Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT04419168
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2020-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cjonassaint@pitt.edu', 'phone': '412-586-9850', 'title': 'Dr. Charles Jonassaint', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.', 'otherNumAtRisk': 181, 'deathsNumAtRisk': 181, 'otherNumAffected': 0, 'seriousNumAtRisk': 181, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 0, 'seriousNumAtRisk': 178, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6-month Change in PROMIS Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000', 'lowerLimit': '-3.42', 'upperLimit': '-0.84'}, {'value': '-2.66', 'groupId': 'OG001', 'lowerLimit': '-3.97', 'upperLimit': '-1.36'}]}]}], 'analyses': [{'pValue': '.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.54', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '2.37', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': "The 8-item Patient Reported Outcomes Measure Information System Pain Interference (PROMIS-8a) assesses the effect of patient-reported pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. The items use 1-5 Likert scale with higher scores indicating greater pain interference. The raw total score (ranging from 8 to 40) is transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Higher T-scores indicate greater pain.", 'unitOfMeasure': 'T-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '6-month Change in Daily Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '0.58'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '-0.25', 'upperLimit': '0.51'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.61', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'At each timepoint, participants will be asked to enter their daily pain via a mobile website for 2 weeks. The mean pain intensity is calculated during this 2 week period and used for analyses. Pain ratings range from 0-10 where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of randomization participants with sufficient pain diary data over the 2 week period after each visit.'}, {'type': 'SECONDARY', 'title': '6-month Change in Patient Health Questionnaire (PHQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.33', 'groupId': 'OG000', 'lowerLimit': '-2.28', 'upperLimit': '-0.39'}, {'value': '-1.12', 'groupId': 'OG001', 'lowerLimit': '-2.06', 'upperLimit': '-0.18'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '1.12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'PHQ-9 assesses the degree of depression severity. The PHQ-9 total score is for nine items, all rated as 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of randomization participants with PHQ2\\>0.'}, {'type': 'SECONDARY', 'title': '6-month Change in Generalized Anxiety Disorder Scale-7 (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.85', 'groupId': 'OG000', 'lowerLimit': '-1.68', 'upperLimit': '-0.01'}, {'value': '-1.49', 'groupId': 'OG001', 'lowerLimit': '-2.40', 'upperLimit': '-0.58'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '1.87', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'GAD-7 evaluates the severity of anxiety. The GAD-7 total score for the 7 items ranges from 0 to 21. Scores of 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of randomization participants with GAD2\\>0.'}, {'type': 'SECONDARY', 'title': '6-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'title': 'ASCQ-ME Social Functioning Impact', 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '3.76'}, {'value': '2.34', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.68'}]}]}, {'title': 'ASCQ-Me Emotional Impact', 'categories': [{'measurements': [{'value': '3.51', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '4.73'}, {'value': '1.79', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '3.04'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '1.99', 'groupDescription': 'These results correspond to ASCQ-Me Social Functioning Impact only.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '3.46', 'groupDescription': 'These results correspond to ASCQ-Me Emotional Impact only.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The ASCQ-ME emotional functioning and social impact quality-of-life measure was specifically designed for SCD and evaluates the health care experience of patients with SCD, emotional response to stress, and social relationships. For each subscale (emotional impact in the past 7 days and social functioning impact in the past 30 days), there are 5 questions using a 1-5 Likert scale with lower scores indicating worse health. Raw total scores (ranging from 5 to 25) are transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Lower T-scores indicate worse health.', 'unitOfMeasure': 'T-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '6-month Change in Sickle Cell Self-Efficacy Scale (SCSES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '2.46'}, {'value': '0.32', 'groupId': 'OG001', 'lowerLimit': '-0.70', 'upperLimit': '1.35'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '2.56', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The Sickle Cell Disease Self-Efficacy Scale is a nine-item self-administered questionnaire that measures disease-specific perceptions of the ability to manage day-to-day issues resulting from sickle cell disease (SCD). Items are scores according to a five-point scale ranging from "1 - Not sure at all" to "5 - Very sure." Responses from individual items are summed to give an overall score with higher scores indicating greater self-efficacy (ranging from 9 to 45).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0338', 'groupId': 'OG000', 'lowerLimit': '-0.0633', 'upperLimit': '-0.0042'}, {'value': '-0.0314', 'groupId': 'OG001', 'lowerLimit': '-0.0611', 'upperLimit': '-0.0016'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0024', 'ciLowerLimit': '-0.0443', 'ciUpperLimit': '0.0395', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Painimation is an electronic pain assessment tool that allows users to better communicate pain symptoms. Patients are provided with a selection of animations (painimations) that they use to describe the quality of their pain. The painimations can be adjusted to reflect pain intensity. Screenshots of the Painimation app illustrate the splash screen, paintable body image, and selection of painimations to indicate the quality and intensity of pain. A higher mean % is indicative of greater pain. For analyses, mean percentages are transformed via arc-sine square in order to normalize.', 'unitOfMeasure': 'percentage of total body area shaded', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '12-month Change in PROMIS Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.50', 'groupId': 'OG000', 'lowerLimit': '-2.94', 'upperLimit': '-0.07'}, {'value': '-1.93', 'groupId': 'OG001', 'lowerLimit': '-3.39', 'upperLimit': '-0.47'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '2.48', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': "The 8-item Patient Reported Outcomes Measure Information System Pain Interference (PROMIS-8a) assesses the effect of patient-reported pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. The items use 1-5 Likert scale with higher scores indicating greater pain interference. The raw total score (ranging from 8 to 40) is transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Higher T-scores indicate greater pain.", 'unitOfMeasure': 'T-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '12-month Change in Daily Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.44'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.42', 'upperLimit': '0.37'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.63', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'At each timepoint, participants will be asked to enter their daily pain via a mobile website for 2 weeks. The mean pain intensity is calculated during this 2 week period and used for analyses. Pain ratings range from 0-10 where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of randomization participants with sufficient pain diary data over the 2 week period after each visit.'}, {'type': 'SECONDARY', 'title': '12-month Change in Patient Health Questionnaire (PHQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.34', 'groupId': 'OG000', 'lowerLimit': '-2.39', 'upperLimit': '-0.29'}, {'value': '-0.24', 'groupId': 'OG001', 'lowerLimit': '-1.24', 'upperLimit': '0.77'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-2.56', 'ciUpperLimit': '0.35', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'PHQ-9 assesses the degree of depression severity. The PHQ-9 total score is for nine items, all rated as 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PHQ-9 for Clinic participants and PHQ-8 for Virtual participants with baseline PHQ-2 \\>0'}, {'type': 'SECONDARY', 'title': '12-month Change in Generalized Anxiety Disorder Scale-7 (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.70', 'groupId': 'OG000', 'lowerLimit': '-1.69', 'upperLimit': '0.29'}, {'value': '-0.46', 'groupId': 'OG001', 'lowerLimit': '-1.52', 'upperLimit': '0.59'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '1.21', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'GAD-7 evaluates the severity of anxiety. The GAD-7 total score for the 7 items ranges from 0 to 21. Scores of 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'GAD-7 for all participants with baseline GAD-2 \\>0'}, {'type': 'SECONDARY', 'title': '12-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'title': 'ASCQ-Me Social Functioning Impact', 'categories': [{'measurements': [{'value': '2.31', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '3.72'}, {'value': '1.61', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '3.04'}]}]}, {'title': 'ASCQ-Me Emotional Impact', 'categories': [{'measurements': [{'value': '3.03', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '4.34'}, {'value': '1.03', 'groupId': 'OG001', 'lowerLimit': '-0.31', 'upperLimit': '2.37'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '2.71', 'groupDescription': 'These results correspond to ASCQ-Me Social Functioning Impact only.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '0.12', 'ciUpperLimit': '3.88', 'groupDescription': 'These results correspond to ASCQ-Me Emotional Impact only.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The ASCQ-ME emotional functioning and social impact quality-of-life measure was specifically designed for SCD and evaluates the health care experience of patients with SCD, emotional response to stress, and social relationships. For each subscale (emotional impact in the past 7 days and social functioning impact in the past 30 days), there are 5 questions using a 1-5 Likert scale with lower scores indicating worse health. Raw total scores (ranging from 5 to 25) are transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Lower T-scores indicate worse health.', 'unitOfMeasure': 'T-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '12-month Change in Sickle Cell Self-Efficacy Scale (SCSES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '0.40', 'upperLimit': '2.61'}, {'value': '-0.63', 'groupId': 'OG001', 'lowerLimit': '-1.75', 'upperLimit': '0.50'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.13', 'ciLowerLimit': '0.56', 'ciUpperLimit': '3.71', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The Sickle Cell Disease Self-Efficacy Scale is a nine-item self-administered questionnaire that measures disease-specific perceptions of the ability to manage day-to-day issues resulting from sickle cell disease (SCD). Items are scores according to a five-point scale ranging from "1 - Not sure at all" to "5 - Very sure." Responses from individual items are summed to give an overall score with higher scores indicating greater self-efficacy (ranging from 9 to 45).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '12-month Change in Current Opioid Misuse Measure (COMM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.72', 'groupId': 'OG000', 'lowerLimit': '-2.54', 'upperLimit': '-0.91'}, {'value': '-1.38', 'groupId': 'OG001', 'lowerLimit': '-2.21', 'upperLimit': '-0.55'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '0.82', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Current Opioid Misuse Measure (COMM) is a self-reported measure to monitor indicators of current aberrant drug-related behaviors in patients with chronic pain on opioid therapy. Total scores are summed across the 9 individual items and range from 0-36, with higher scores representing greater misuse.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.08', 'upperLimit': '-0.02'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '-0.02'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0013', 'ciLowerLimit': '-0.0464', 'ciUpperLimit': '0.0437', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Painimation is an electronic pain assessment tool that allows users to better communicate pain symptoms. Patients are provided with a selection of animations (painimations) that they use to describe the quality of their pain. The painimations can be adjusted to reflect pain intensity. Screenshots of the Painimation app illustrate the splash screen, paintable body image, and selection of painimations to indicate the quality and intensity of pain. A higher mean % is indicative of greater pain. For analyses, mean percentages are transformed via arc-sine square in order to normalize.', 'unitOfMeasure': 'percentage of total body area shaded', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Opioid Prescriptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.15', 'groupId': 'OG000', 'lowerLimit': '23.97', 'upperLimit': '37.91'}, {'value': '27.19', 'groupId': 'OG001', 'lowerLimit': '21.77', 'upperLimit': '33.95'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.48', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': "For patients recruited at one of the six clinical sites, study team will evaluate objectively measured opioid medication prescriptions and refills. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records.", 'unitOfMeasure': 'Prescriptions per person-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of randomization participants with available data from PCORnet.'}, {'type': 'SECONDARY', 'title': 'Number of Emergency Department Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.65', 'groupId': 'OG000', 'lowerLimit': '1.92', 'upperLimit': '3.66'}, {'value': '1.86', 'groupId': 'OG001', 'lowerLimit': '1.34', 'upperLimit': '2.59'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '0.93', 'ciUpperLimit': '2.18', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': "For patients recruited at one of the six clinical sites, study team will evaluate objectively measured emergency department visits. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records.", 'unitOfMeasure': 'ED visits per person-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of randomization participants with available data from PCORnet.'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'OG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.62'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '1.23'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.85', 'ciUpperLimit': '2.03', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': "For patients recruited at one of the six clinical sites, study team will evaluate objectively measured hospitalizations. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records.", 'unitOfMeasure': 'Hospitalizations per person-year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of randomization participants with available data from PCORnet.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'FG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': '3-month Follow up Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Missed 6-month Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '45'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.\n\ncCBT: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.'}, {'id': 'BG001', 'title': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.\n\nm-Education: A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.4', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '36.3', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Biological Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PROMIS Pain Interference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62.2', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '7', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The 8-item Patient Reported Outcomes Measure Information System Pain Interference (PROMIS-8a) assesses the effect of patient-reported pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. The items use 1-5 Likert scale with higher scores indicating greater pain interference. The raw total score (ranging from 8 to 40) is transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Higher T-scores indicate greater pain.", 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average pain intensity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '4.4', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'At each timepoint, participants will be asked to enter their daily pain via a mobile website for 2 weeks. The mean pain intensity is calculated during this 2 week period and used for analyses. Pain ratings range from 0-10 where 0 is no pain and 10 is the worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants who completed the pain diary were included.'}, {'title': 'Patient Health Questionnaire (PHQ)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'spread': '5', 'groupId': 'BG000'}, {'value': '10', 'spread': '5', 'groupId': 'BG001'}, {'value': '10', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'PHQ-9 assesses the degree of depression severity. The PHQ-9 total score is for nine items, all rated as 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants who scored \\>0 on PHQ-2 (first two items of the PHQ) were administered the rest of the survey.'}, {'title': 'Generalized Anxiety Disorder Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'spread': '5', 'groupId': 'BG000'}, {'value': '9', 'spread': '5', 'groupId': 'BG001'}, {'value': '9', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'GAD-7 evaluates the severity of anxiety. The GAD-7 total score for the 7 items ranges from 0 to 21. Scores of 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants who scored \\>0 on GAD-2 (first two items of the GAD) were administered the rest of the survey.'}, {'title': 'Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME)', 'classes': [{'title': 'Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47.4', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '47.3', 'spread': '7.9', 'groupId': 'BG002'}]}]}, {'title': 'Emotional Impact', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47.2', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '48.8', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '48.0', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The ASCQ-ME emotional functioning and social impact quality-of-life measure was specifically designed for SCD and evaluates the health care experience of patients with SCD, emotional response to stress, and social relationships. For each subscale (emotional impact and social functioning impact), there are 5 questions using a 1-5 Likert scale with lower scores indicating worse health. Raw total scores (ranging from 5 to 25) are transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Lower T-scores indicate worse health.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sickle Cell Self-Efficacy Scale (SCSES)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'spread': '6', 'groupId': 'BG000'}, {'value': '29', 'spread': '7', 'groupId': 'BG001'}, {'value': '29', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Sickle Cell Disease Self-Efficacy Scale is a nine-item self-administered questionnaire that measures disease-specific perceptions of the ability to manage day-to-day issues resulting from sickle cell disease (SCD). Items are scores according to a five-point scale ranging from "1 - Not sure at all" to "5 - Very sure." Responses from individual items are summed to give an overall score with higher scores indicating greater self-efficacy (ranging from 9 to 45).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Body Area Shaded (Painimation)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '14', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '13.5', 'spread': '15.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Painimation is an electronic pain assessment tool that allows users to better communicate pain symptoms. Patients are provided with a selection of animations (painimations) that they use to describe the quality of their pain. For each participant, there are 22 body sections that can be shaded to show where they have pain. To get the percent of total body area shaded across all sections of the body, the sum of the body area shaded for each section of the body (numerator) was divided by the sum of the total body area of each section that could be shaded (denominator).', 'unitOfMeasure': 'mean percentage of total body area shade', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current Opioid Misuse Measure (COMM)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'spread': '6', 'groupId': 'BG000'}, {'value': '8', 'spread': '5', 'groupId': 'BG001'}, {'value': '9', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Current Opioid Misuse Measure (COMM) is a self-report measure to monitor indicators of current aberrant drug-related behaviors in patients with chronic pain on opioid therapy. Total scores are summed across the 9 individual items and range from 0-36, with higher scores representing greater misuse.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-15', 'size': 1788834, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-19T10:39', 'hasProtocol': True}, {'date': '2023-01-13', 'size': 181585, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-15T14:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'comparative effectiveness trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 359}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2020-05-28', 'resultsFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-27', 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month Change in PROMIS Pain Interference', 'timeFrame': 'Baseline and 6 months', 'description': "The 8-item Patient Reported Outcomes Measure Information System Pain Interference (PROMIS-8a) assesses the effect of patient-reported pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. The items use 1-5 Likert scale with higher scores indicating greater pain interference. The raw total score (ranging from 8 to 40) is transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Higher T-scores indicate greater pain."}], 'secondaryOutcomes': [{'measure': '6-month Change in Daily Pain Intensity', 'timeFrame': 'Baseline and 6 months', 'description': 'At each timepoint, participants will be asked to enter their daily pain via a mobile website for 2 weeks. The mean pain intensity is calculated during this 2 week period and used for analyses. Pain ratings range from 0-10 where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': '6-month Change in Patient Health Questionnaire (PHQ)', 'timeFrame': 'Baseline and 6 months', 'description': 'PHQ-9 assesses the degree of depression severity. The PHQ-9 total score is for nine items, all rated as 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.'}, {'measure': '6-month Change in Generalized Anxiety Disorder Scale-7 (GAD-7)', 'timeFrame': 'Baseline and 6 months', 'description': 'GAD-7 evaluates the severity of anxiety. The GAD-7 total score for the 7 items ranges from 0 to 21. Scores of 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively.'}, {'measure': '6-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME)', 'timeFrame': 'Baseline and 6 months', 'description': 'The ASCQ-ME emotional functioning and social impact quality-of-life measure was specifically designed for SCD and evaluates the health care experience of patients with SCD, emotional response to stress, and social relationships. For each subscale (emotional impact in the past 7 days and social functioning impact in the past 30 days), there are 5 questions using a 1-5 Likert scale with lower scores indicating worse health. Raw total scores (ranging from 5 to 25) are transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Lower T-scores indicate worse health.'}, {'measure': '6-month Change in Sickle Cell Self-Efficacy Scale (SCSES)', 'timeFrame': 'Baseline and 6 months', 'description': 'The Sickle Cell Disease Self-Efficacy Scale is a nine-item self-administered questionnaire that measures disease-specific perceptions of the ability to manage day-to-day issues resulting from sickle cell disease (SCD). Items are scores according to a five-point scale ranging from "1 - Not sure at all" to "5 - Very sure." Responses from individual items are summed to give an overall score with higher scores indicating greater self-efficacy (ranging from 9 to 45).'}, {'measure': 'Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'Painimation is an electronic pain assessment tool that allows users to better communicate pain symptoms. Patients are provided with a selection of animations (painimations) that they use to describe the quality of their pain. The painimations can be adjusted to reflect pain intensity. Screenshots of the Painimation app illustrate the splash screen, paintable body image, and selection of painimations to indicate the quality and intensity of pain. A higher mean % is indicative of greater pain. For analyses, mean percentages are transformed via arc-sine square in order to normalize.'}, {'measure': '12-month Change in PROMIS Pain Interference', 'timeFrame': 'Baseline and 12 months', 'description': "The 8-item Patient Reported Outcomes Measure Information System Pain Interference (PROMIS-8a) assesses the effect of patient-reported pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. The items use 1-5 Likert scale with higher scores indicating greater pain interference. The raw total score (ranging from 8 to 40) is transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Higher T-scores indicate greater pain."}, {'measure': '12-month Change in Daily Pain Intensity', 'timeFrame': 'Baseline and 12 months', 'description': 'At each timepoint, participants will be asked to enter their daily pain via a mobile website for 2 weeks. The mean pain intensity is calculated during this 2 week period and used for analyses. Pain ratings range from 0-10 where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': '12-month Change in Patient Health Questionnaire (PHQ)', 'timeFrame': 'Baseline and 12 months', 'description': 'PHQ-9 assesses the degree of depression severity. The PHQ-9 total score is for nine items, all rated as 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.'}, {'measure': '12-month Change in Generalized Anxiety Disorder Scale-7 (GAD-7)', 'timeFrame': 'Baseline and 12 months', 'description': 'GAD-7 evaluates the severity of anxiety. The GAD-7 total score for the 7 items ranges from 0 to 21. Scores of 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively.'}, {'measure': '12-month Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME)', 'timeFrame': 'Baseline and 12 months', 'description': 'The ASCQ-ME emotional functioning and social impact quality-of-life measure was specifically designed for SCD and evaluates the health care experience of patients with SCD, emotional response to stress, and social relationships. For each subscale (emotional impact in the past 7 days and social functioning impact in the past 30 days), there are 5 questions using a 1-5 Likert scale with lower scores indicating worse health. Raw total scores (ranging from 5 to 25) are transformed using a T-score for a mean of 50, standard deviation of 10, in referent population. Lower T-scores indicate worse health.'}, {'measure': '12-month Change in Sickle Cell Self-Efficacy Scale (SCSES)', 'timeFrame': 'Baseline and 12 months', 'description': 'The Sickle Cell Disease Self-Efficacy Scale is a nine-item self-administered questionnaire that measures disease-specific perceptions of the ability to manage day-to-day issues resulting from sickle cell disease (SCD). Items are scores according to a five-point scale ranging from "1 - Not sure at all" to "5 - Very sure." Responses from individual items are summed to give an overall score with higher scores indicating greater self-efficacy (ranging from 9 to 45).'}, {'measure': '12-month Change in Current Opioid Misuse Measure (COMM)', 'timeFrame': 'Baseline and 12 months', 'description': 'Current Opioid Misuse Measure (COMM) is a self-reported measure to monitor indicators of current aberrant drug-related behaviors in patients with chronic pain on opioid therapy. Total scores are summed across the 9 individual items and range from 0-36, with higher scores representing greater misuse.'}, {'measure': 'Change From Baseline in Percent of Total Body Area Shaded (Painimation) at 12 Months', 'timeFrame': '12 months', 'description': 'Painimation is an electronic pain assessment tool that allows users to better communicate pain symptoms. Patients are provided with a selection of animations (painimations) that they use to describe the quality of their pain. The painimations can be adjusted to reflect pain intensity. Screenshots of the Painimation app illustrate the splash screen, paintable body image, and selection of painimations to indicate the quality and intensity of pain. A higher mean % is indicative of greater pain. For analyses, mean percentages are transformed via arc-sine square in order to normalize.'}, {'measure': 'Number of Opioid Prescriptions', 'timeFrame': '12 months', 'description': "For patients recruited at one of the six clinical sites, study team will evaluate objectively measured opioid medication prescriptions and refills. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records."}, {'measure': 'Number of Emergency Department Visits', 'timeFrame': '12 months', 'description': "For patients recruited at one of the six clinical sites, study team will evaluate objectively measured emergency department visits. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records."}, {'measure': 'Number of Hospitalizations', 'timeFrame': '12 months', 'description': "For patients recruited at one of the six clinical sites, study team will evaluate objectively measured hospitalizations. Study team will work in collaboration with PCORnet to collect outcome data 12 months after enrollment from patients' electronic health records."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sickle cell disease', 'pain', 'opioids', 'depression', 'cognitive behavioral therapy', 'mobile technology', 'digital health', 'mHealth', 'implementation science', 'community-based participatory research'], 'conditions': ['Chronic Pain', 'Depression, Anxiety', 'Opioid Use']}, 'referencesModule': {'references': [{'pmid': '40763347', 'type': 'DERIVED', 'citation': "Oluwole OB, McGill LS, Gayle K, O'Brien JA, Abebe KZ, Jonassaint CR, Hamm M. Experiences With a Multicomponent Digital Behavioral Pain Management Intervention for Adults With Sickle Cell Disease: Qualitative Analysis of the CaRISMA Trial. JMIR Hum Factors. 2025 Aug 5;12:e73719. doi: 10.2196/73719."}, {'pmid': '38171495', 'type': 'DERIVED', 'citation': "Jonassaint CR, Parchuri E, O'Brien JA, Lalama CM, Lin J, Badawy SM, Hamm ME, Stinson J, Lalloo C, Carroll CP, Saraf SL, Gordeuk VR, Cronin R, Shah N, Lanzkron SM, Liles D, Trimnell C, Bailey L, Lawrence RH, Abebe KZ. Mental health, pain and likelihood of opioid misuse among adults with sickle cell disease. Br J Haematol. 2024 Mar;204(3):1029-1038. doi: 10.1111/bjh.19243. Epub 2024 Jan 3."}, {'pmid': '33988517', 'type': 'DERIVED', 'citation': 'Badawy SM, Abebe KZ, Reichman CA, Checo G, Hamm ME, Stinson J, Lalloo C, Carroll P, Saraf SL, Gordeuk VR, Desai P, Shah N, Liles D, Trimnell C, Jonassaint CR. Comparing the Effectiveness of Education Versus Digital Cognitive Behavioral Therapy for Adults With Sickle Cell Disease: Protocol for the Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA) Study. JMIR Res Protoc. 2021 May 14;10(5):e29014. doi: 10.2196/29014.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are conducting a comparative effectiveness trial among adult patients with sickle cell disease (SCD) who report chronic pain (N = 350), randomized to receive either mobile phone-delivered computerized cognitive behavioral therapy (cCBT; n = 175) or digital education (m-Education; n = 175). Both intervention groups will receive weekly (more frequent if requested or needed) follow-up with a health coach for at least 3 months to reinforce learned materials. Both groups will also use their mobile device to track daily pain, mood, and medication used for two-week periods at baseline and each of the follow-up points (3, 6 and 12 months). Participants will also be given access to a study-associated online support group page where members can discuss with other patients, issues participants faced and what skills were or could be used to address them. Participants will continue all routine care including opioid pain management and novel therapies.', 'detailedDescription': 'CaRISMA is a randomized comparative effectiveness trial among adult patients with SCD who report chronic pain (N = 350) randomized to receive either cCBT (n = 175) or m-Education (n = 175). A third group of adult patients with SCD who do not meet the criteria for having chronic pain or who are not interested in participating in the intervention will be a convenience non-chronic pain comparison group and will not receive any intervention or scheduled follow-up. The non-chronic pain comparison group will only complete the battery of questionnaires at baseline and each time they return to the clinic for a medical visit. The study will access patients\' stored information or verbally obtained information to assess a person\'s eligibility and suitability for potential participation in the study.\n\nAll adult patients, age 18 or above, with a self-report SCD diagnosis, are willing to complete a brief stress and pain functioning screener (stress/pain screener). The stress/pain screener includes measures of depression, anxiety, disability, pain (intensity, quality, and location), and quality of life. The PHQ-9 and GAD-7 measures are administered as part of routine clinical care at the UPMC comprehensive sickle cell clinic and will both be utilized as part of the stress and pain functioning screener for research purposes in the study. Each patient completes electronic versions of all or some of these scales before the sickle cell clinic social worker or psychologist sees them. The total screener typically takes patients about 15-20 minutes to complete.\n\nPatients who do meet the criteria for having chronic pain will be randomized to one of the two intervention groups. For at least 12 weeks, one group will be asked to engage in a mobile cCBT program tailored for adults with SCD. The second group will receive pain and SCD education on mobile phones (m-Education). Both programs use identical mobile technology platforms; only the content differs. The cCBT program focuses on teaching behavioral coping skills through participants\' "seeing and doing" while the pain education arm focuses on improving self-management through participants\' "learning and knowing" more about pain and SCD. All participants in the intervention group will have weekly follow-ups with a health coach and will track pain symptoms daily during the intervention. A smartphone is required to participate in the intervention. If an interested and eligible participant does not have a smartphone, one may be provided to them. Upon completion of the study, the participant may keep the phone after completing all study elements, including having the study team remove all study-related data from the phone.\n\nBoth arms of the intervention will be delivered through pre-programmed chatbot interactions administered in a mobile messaging app. The intervention arm is automatically assigned via the chatbot. When the CaRISMA intervention is opened for the first time, it will automatically randomize each participant to either study arm: cCBT or m-Education. The participants will not know which arm they have been assigned to, and they will only have access to the materials included in the respective study arm\n\nParticipants will receive a link to our online survey tool where they will be asked to respond to a set of questionnaires and Painimation, a novel pain assessment tool.\n\nThe questionnaires are as follows: Sickle Cell Self-Efficacy Scale (SCSS), Patient- Reported Outcomes Measurement Information System (PROMIS) Pain Interference, Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorders Scale (GAD- 7), and the Current Opioid Misuse Measure (COMM). For participants who are eligible to be randomized, in addition to baseline questionnaires, items from the Coping Strategies Questionnaire (CSQ) will be asked through the messaging app as participants progress through their respective programs.\n\nThe Painimation tool is an electronic pain assessment tool developed by our team at the University of Pittsburgh that allows users to better communicate their pain symptoms. Patients are provided with a selection of animations that they use to describe the quality of their pain. The animations can be increased or decreased in speed, color saturation, focus, and size, to reflect the intensity of their pain.\n\nFor intervention participants, in addition to the quantitative assessments, our partners at the Qualitative, Evaluation, And Stakeholder Engagement (Qual EASE) Research Services will conduct a set of qualitative interviews to further understand which intervention works best for whom and when, the lived experience of patients in the trial, and differences in perceptions between depression subgroups. Qual- EASE will randomly select 48 participants (of the 350) to be interviewed. Attending the qualitative interviews is completely voluntary and participants may opt out at any time. However, if one of the 48 selected participants does opt out, Qual-EASE will invite another participant, of those not previously selected, as a replacement.\n\nIn the first three months of the study, intervention participants will complete all modules of their assigned study arm (cCBT or m-Education) at their own pace. The recommended progression is one module per week; this will give participants time to practice the techniques taught in each module. Participants will be asked to complete a daily electronic diary to track their pain symptoms. Only intervention arm participants will receive follow-up assessment. The convenience comparison group will not be followed with scheduled assessments.\n\nAt the 3-month assessment (T1) (i.e., three months after enrollment, on the same date the participant began the study) participants will again receive a link to our online survey tool to complete the second iteration of Painimation, the SCSS, PROMIS, ASCQ-ME, PHQ-9 and GAD-7. If participants have questions while completing these questionnaires, they may contact their health coach for guidance.\n\nParticipants will also be asked to complete daily pain intensity entries in the electronic diary. If participants do not complete the questionnaires or the pain intensity entries, health coaches will contact them and remind them to do so. The 48 patients selected for qualitative interviews will have their second interview with Qual- EASE at this time.\n\nBetween months 4-6, participants will continue to use the CaRISMA intervention but will no longer have weekly follow-ups with a health coach except upon request or on an as-needed basis. At the end of month 6 (T2), they will receive a link to our online survey tool to complete Painimation, the SCSS, PROMIS, ASCQ-ME, PHQ-9, and GAD-7 for the third time. Participants will continue to complete daily pain intensity entries through the electronic diary.\n\nBetween months 6-12, participants will continue daily pain diary submissions and communication with health coaches only as desired. Additionally, Qual-EASE will conduct the final set of qualitative interviews with 48 of the 350 participants.\n\nIn the final month of the study (T3), participants will receive a link to our online survey tool to complete Painimation, the SCSS, PROMIS, ASCQ-ME, PHQ-9, GAD- 7 and COMM for the final time.\n\nThe pain diary may include some version of the following types of questions in daily assessments:\n\n* Using any number from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable, what is your pain level today?\n* Did you take opiate medications today?\n* Which one of the following emojis best represents your mood today? The pain diary may include some version of the following types of questions in weekly assessments:\n* Using any number from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable, what is your pain level today?\n* Did you take opiate medications today?\n* Compared to what you used yesterday, is the amount of opiate meds you took today less than yesterday, the same as yesterday, or more than yesterday?\n* Did you take non-opiate medications today?\n* This past week, how often have you been bothered by little interest or pleasure in doing things?\n* This past week, how often have you been bothered by feeling down, depressed, or irritable?\n* This past week, how often have you been bothered by feeling nervous, anxious, or on edge?\n* This past week, how often have you been bothered by not being able to stop or control worry?\n\nMedical Outcomes (PCORnet). For patients recruited at one of the five clinical sites, we will evaluate objectively measured opioid medication refills and emergency department visits or hospitalizations for pain crisis. We will be working in collaboration with PCORnet to collect data retrospectively (from the past 12 months) and prospectively (12 months from the date of enrollment) from patient medical records.\n\nThese data will allow us to track medications including opioid pain medication prescriptions and refills, and health care utilization (i.e., emergency department visits and hospitalizations), as well as lab values (e.g., hemoglobin level) and clinical outcomes (e.g., end-organ damage score). For the patients recruited from our community partner organizations or online who are not affiliated with a participating clinical center, we will only acquire or evaluate their medical records for the purpose of confirming their sickle cell diagnosis.\n\nThe primary outcome is the change in pain interference at 6 months. Secondary outcomes include changes in pain intensity, depression (PHQ), anxiety (GAD), quality of life (ASCQ-ME), self-efficacy (SCSES), opioid misuse (COMM), and health care utilization at 6 and 12 months. The study team has updated the outcomes to be more comprehensive due to the funder\'s requirement that it align with the contract milestones'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with any type of sickle cell disease\n* Male or female, age 18 years or older\n* Reports chronic pain: i.e pain more days that not for the past 3 months or longer and/or is prescribed daily or long-acting opioids for pain.\n* English speaking\n\nExclusion Criteria:\n\n* Any potential participants who fail consent comprehension questions'}, 'identificationModule': {'nctId': 'NCT04419168', 'acronym': 'CaRISMA', 'briefTitle': 'Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications', 'orgStudyIdInfo': {'id': 'STUDY20110346'}, 'secondaryIdInfos': [{'id': 'CER-2018C2-13320 20', 'type': 'OTHER_GRANT', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cCBT', 'description': 'Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.', 'interventionNames': ['Other: cCBT']}, {'type': 'EXPERIMENTAL', 'label': 'm-Education', 'description': 'Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.', 'interventionNames': ['Other: m-Education']}], 'interventions': [{'name': 'cCBT', 'type': 'OTHER', 'description': 'A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.', 'armGroupLabels': ['cCBT']}, {'name': 'm-Education', 'type': 'OTHER', 'description': 'A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.', 'armGroupLabels': ['m-Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinous-Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kaleab Abebe, PhD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}