Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-10 @ 1:23 AM
Study NCT ID:
NCT02701361
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Mindfulness to Improve Psychological Distress After Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christopher.cox@duke.edu', 'phone': '9196817232', 'title': 'Christopher Cox', 'organization': 'Duke University Health System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Eligible Participants Who Provided Consent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Subjects Approached to Participate in the Study', 'description': 'All eligible subjects approached to participate in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'pre-randomization', 'description': 'Percent of eligible participants who provided consent. Because this includes eligible yet not-as-yet randomized participants, there are no study arm differences analyzed. This is a feasibility measure. Target is 70%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '121, not 90 subjects, are analyzed because this outcome measure applies to a pre-consent and pre-randomization time period.'}, {'type': 'PRIMARY', 'title': 'Percent of Eligible Participants Who Provide Informed Consent and Were Randomized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'randomization', 'description': 'Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Following consent, two participants were found to be ineligible.'}, {'type': 'PRIMARY', 'title': 'Client Satisfaction Questionnaire (CSQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}, {'id': 'OG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.'}, {'id': 'OG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '25.7', 'spread': '3.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month post-randomization', 'description': 'Acceptability was measured with the adapted Client Satisfaction Questionnaire (CSQ), which assesses credibility and satisfaction (range 9 \\[low, a worse outcome\\] to 36 \\[highest, a better outcome\\]). Target is mean score \\>10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'System Usability Scale (SUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.5', 'spread': '13.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 month post-randomization', 'description': 'Usability of the mobile app was assessed with open-ended participant feedback and with the 10-item System Usability Scale (SUS; 0 \\[lowest\\] to 100 \\[highest\\]). A SUS score above a 68 would be considered above average and anything below 68 is below average.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Randomized Participants Who Drop Out of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}, {'id': 'OG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.'}, {'id': 'OG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.'}], 'classes': [{'title': 'before intervention initiated', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'after intervention initiated', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'A feasibility measure. Target is 20% or less.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}, {'id': 'OG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.'}, {'id': 'OG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'Percent of participants who have neither dropped out nor died who complete telephone interviews. A feasibility measure. Target is 75%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Self-directed MBT Sessions Attended by Eligible Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'A feasibility measure. Target is 50% among those who neither dropped out nor died.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Analog Satisfaction Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}], 'timeFrame': 'after intervention completion, up to 8 weeks post-randomization', 'description': 'A measure of acceptability of the intervention. Target mean score is 75% or greater.', 'reportingStatus': 'POSTED', 'populationDescription': 'measure was mistakenly omitted from study CRF and therefore data not collected.'}, {'type': 'PRIMARY', 'title': 'Number of Participant Clicks on Study Website', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}], 'classes': [{'categories': [{'measurements': [{'value': '188.4', 'spread': '220.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'A usability measure obtained using Google Analytics.', 'unitOfMeasure': 'clicks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}, {'id': 'OG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.'}, {'id': 'OG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.8', 'groupId': 'OG000', 'lowerLimit': '-6.6', 'upperLimit': '-2.9'}, {'value': '-3.9', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '-2.2'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-5.3', 'upperLimit': '-0.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'Depression symptoms were assessed with the PHQ-9, a 9-item scale (range 0 \\[no distress\\] to 27 \\[high distress\\]); symptom severity is interpreted as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Distress Associated With Physical Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}, {'id': 'OG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.'}, {'id': 'OG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '-3.7'}, {'value': '-3.7', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '-2.2'}, {'value': '-4.8', 'groupId': 'OG002', 'lowerLimit': '-6.8', 'upperLimit': '-2.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'The PHQ-10 (Patient Health Questionnaire) was used to measure distress associated with physical symptoms (range 0 \\[none\\] to 30 \\[very troublesome\\]).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Mindfulness Skills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}, {'id': 'OG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.'}, {'id': 'OG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '3.0'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '1.3'}, {'value': '-1.3', 'groupId': 'OG002', 'lowerLimit': '-4.1', 'upperLimit': '1.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'Mindfulness skills were measured with the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), a 12-item measure of mindful qualities (range 12 \\[low ability\\] to 48 \\[highest ability\\]).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Psychological Distress Symptoms as Measured by the GAD-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}, {'id': 'OG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.'}, {'id': 'OG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '-0.5'}, {'value': '-1.6', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '-0.1'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-2.5', 'upperLimit': '1.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'Anxiety symptoms were measured using the Generalized Anxiety Disorder 7-item scale (GAD-7; range 0 \\[no distress\\] to 21 \\[high distress\\]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Psychological Distress Symptoms as Measured by the PTSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}, {'id': 'OG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.'}, {'id': 'OG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '1.2'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '1.2'}, {'value': '-3.5', 'groupId': 'OG002', 'lowerLimit': '-8.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'The Post Traumatic Stress Scale (PTSS), a 10-item scale (range 10 \\[no symptoms\\] to 70 \\[high burden of symptoms\\]), was used to assess PTSD symptoms; \\>20 represents clinically important symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Avoidance Domain of the Brief COPE Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.'}, {'id': 'OG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.'}, {'id': 'OG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '1.0'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '-0.03', 'upperLimit': '2.7'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-2.0', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'Coping skills were measured with the Brief COPE scale (range 10 \\[low use\\] to 40 \\[highest use\\]). The Brief COPE is a self-report questionnaire used to assess a number of different coping behaviors and thoughts a person may have in response to a specific situation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Usability Themes Developed From Semi-structured Participant Interviews', 'timeFrame': 'end of study', 'description': 'A usability measure. Open-ended feedback questions will be arranged in themes.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.\n\nmobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.'}, {'id': 'FG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.\n\nstandard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks.'}, {'id': 'FG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.\n\neducation: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'timed out in rehab center', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '90 participants signed consent; 2 participants who signed consent were later found not to be eligible(88 eligible). 80 participants were randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Mobile Mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.\n\nmobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.'}, {'id': 'BG001', 'title': 'Standard Mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.\n\nstandard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks.'}, {'id': 'BG002', 'title': 'Education Group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.\n\neducation: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.7', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '48.1', 'spread': '16.1', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '12.6', 'groupId': 'BG002'}, {'value': '49.5', 'spread': '15.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-09', 'size': 120009, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-10-30T09:43', 'hasProtocol': False}, {'date': '2016-10-14', 'size': 1396929, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-10-30T12:55', 'hasProtocol': True}, {'date': '2016-05-09', 'size': 85946, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-11T13:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-11', 'studyFirstSubmitDate': '2016-02-24', 'resultsFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-14', 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Usability Themes Developed From Semi-structured Participant Interviews', 'timeFrame': 'end of study', 'description': 'A usability measure. Open-ended feedback questions will be arranged in themes.'}], 'primaryOutcomes': [{'measure': 'Percent of Eligible Participants Who Provided Consent', 'timeFrame': 'pre-randomization', 'description': 'Percent of eligible participants who provided consent. Because this includes eligible yet not-as-yet randomized participants, there are no study arm differences analyzed. This is a feasibility measure. Target is 70%.'}, {'measure': 'Percent of Eligible Participants Who Provide Informed Consent and Were Randomized', 'timeFrame': 'randomization', 'description': 'Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.'}, {'measure': 'Client Satisfaction Questionnaire (CSQ) Score', 'timeFrame': '1 month post-randomization', 'description': 'Acceptability was measured with the adapted Client Satisfaction Questionnaire (CSQ), which assesses credibility and satisfaction (range 9 \\[low, a worse outcome\\] to 36 \\[highest, a better outcome\\]). Target is mean score \\>10.'}, {'measure': 'System Usability Scale (SUS)', 'timeFrame': '1 month post-randomization', 'description': 'Usability of the mobile app was assessed with open-ended participant feedback and with the 10-item System Usability Scale (SUS; 0 \\[lowest\\] to 100 \\[highest\\]). A SUS score above a 68 would be considered above average and anything below 68 is below average.'}, {'measure': 'Percent of Randomized Participants Who Drop Out of Study', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'A feasibility measure. Target is 20% or less.'}, {'measure': 'Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'Percent of participants who have neither dropped out nor died who complete telephone interviews. A feasibility measure. Target is 75%.'}, {'measure': 'Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.'}, {'measure': 'Percentage of Self-directed MBT Sessions Attended by Eligible Participants', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'A feasibility measure. Target is 50% among those who neither dropped out nor died.'}, {'measure': 'Visual Analog Satisfaction Scale', 'timeFrame': 'after intervention completion, up to 8 weeks post-randomization', 'description': 'A measure of acceptability of the intervention. Target mean score is 75% or greater.'}, {'measure': 'Number of Participant Clicks on Study Website', 'timeFrame': 'baseline, end of study (approx. 4 months)', 'description': 'A usability measure obtained using Google Analytics.'}], 'secondaryOutcomes': [{'measure': 'Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'Depression symptoms were assessed with the PHQ-9, a 9-item scale (range 0 \\[no distress\\] to 27 \\[high distress\\]); symptom severity is interpreted as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).'}, {'measure': 'Change in Distress Associated With Physical Symptoms', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'The PHQ-10 (Patient Health Questionnaire) was used to measure distress associated with physical symptoms (range 0 \\[none\\] to 30 \\[very troublesome\\]).'}, {'measure': 'Change in Mindfulness Skills', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'Mindfulness skills were measured with the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), a 12-item measure of mindful qualities (range 12 \\[low ability\\] to 48 \\[highest ability\\]).'}, {'measure': 'Change in Psychological Distress Symptoms as Measured by the GAD-7', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'Anxiety symptoms were measured using the Generalized Anxiety Disorder 7-item scale (GAD-7; range 0 \\[no distress\\] to 21 \\[high distress\\]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21).'}, {'measure': 'Change in Psychological Distress Symptoms as Measured by the PTSS', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'The Post Traumatic Stress Scale (PTSS), a 10-item scale (range 10 \\[no symptoms\\] to 70 \\[high burden of symptoms\\]), was used to assess PTSD symptoms; \\>20 represents clinically important symptoms.'}, {'measure': 'Change in the Avoidance Domain of the Brief COPE Scale', 'timeFrame': 'Between randomization and 3 months post-randomization', 'description': 'Coping skills were measured with the Brief COPE scale (range 10 \\[low use\\] to 40 \\[highest use\\]). The Brief COPE is a self-report questionnaire used to assess a number of different coping behaviors and thoughts a person may have in response to a specific situation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mindfulness', 'critical illness', 'intensive care unit', 'mindfulness-based stress reduction'], 'conditions': ['Psychological Distress', 'Depression', 'Anxiety', 'Post-traumatic Stress Disorder', 'Informal Caregivers', 'Family Members']}, 'referencesModule': {'references': [{'pmid': '24303911', 'type': 'BACKGROUND', 'citation': 'Cox CE, Porter LS, Buck PJ, Hoffa M, Jones D, Walton B, Hough CL, Greeson JM. Development and preliminary evaluation of a telephone-based mindfulness training intervention for survivors of critical illness. Ann Am Thorac Soc. 2014 Feb;11(2):173-81. doi: 10.1513/AnnalsATS.201308-283OC.'}, {'pmid': '29793970', 'type': 'DERIVED', 'citation': 'Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.'}]}, 'descriptionModule': {'briefSummary': 'Many survivors of the intensive care unit (ICU) suffer from persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD). In this study, the investigators will test the impact of mindfulness to address this distress.', 'detailedDescription': "A majority of the \\>1 million people who require life support in an intensive care unit (ICU) now survive. As survival has improved however, growing numbers suffer not only from subsequent physical disability, but also persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD). Few interventions address ICU survivors' psychological distress. Fewer still address the physical, geographical, and logistical barriers to receiving post-discharge support that medically ill populations encounter. Consequently, this population suffers with an unmet need of great public health importance.\n\nMindfulness is an adaptable self-regulation practice that alleviates psychological distress symptoms using a variety of meditative techniques, typically taught face-to face over months. As an extension of standard mindfulness practices, the investigators developed a telephone-/web-delivered mobile mindfulness-based training (mMBT) system informed by ICU survivors' input that could address medically ill patients' delivery barriers. The investigators' recent pilot study demonstrated early support for mMBT's feasibility and acceptability, now with enhanced content and electronic patient-reported outcomes capability.\n\nThe investigators' early work on mMBT, while promising, identified key knowledge gaps in population targeting, plausible ranges of psychological distress estimates relevant to study design, and assurance of acceptability that must be addressed before a definitive clinical trial is conducted. Therefore, the study team proposes a 2-year pilot study in which 90 ICU survivors are randomized to an education control, 'standard' telephone sessions of mMBT, or self-directed / app-based mMBT. A mixed methods approach will be used to determine treatment effect."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (the investigators will target patients at high risk for psychological distress):\n\n* age ≥18 years\n* acute cardiorespiratory failure managed in an intensive care unit\n* reside at home before hospital admission (i.e., not in a facility)\n\n * Respiratory failure, ≥1 of these:\n* mechanical ventilation via endotracheal tube for ≥ 12 hours\n* non-invasive ventilation (CPAP, BiPAP) for \\> 4 hours in a 24 hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)\n* high flow nasal cannula or face mask O2 with FiO2 ≥ 0.5 for ≥4 hours\n\n * Cardiac / circulatory failure, ≥1 of these:\n* use of vasopressors for shock of any etiology for \\> 1 hour\n* use of inotropes for shock of any etiology for \\> 1 hour\n* use of aortic balloon pump for cardiogenic shock\n\nExclusion Criteria (present before consent): Patients will be excluded if they have characteristics that would prohibit adequate participation including:\n\n* pre-existing significant cognitive impairment (e.g., dementia)\n* treated for severe or unstable mental illness within 6 months preceding current admission (e.g., depression with psychosis, suicidality, schizophrenia as per medical record)\n* hospital inpatient within 3 months before current admission\n* active substance abuse at the time of admission\n* lack of decisional capacity \\[\\*'Decisional capacity' is defined as the ability to participate in effective decision making and provide informed consent. That is, in the judgment of the examiner, the patient, after reading the IRB approved patient consent document (or having it read to them) can (a) generally understand the terms of participation in the study: the purpose of the study, what will be required of study participants; the potential risks, benefits and alternatives of study participation; pros \\& cons of study involvement and (b) can communicate a choice in his/her own words (or write on a communication board)\\]\n* current significant cognitive impairment (≥3 errors on the Callahan cognitive status screen; see below)\n* need for a translator because of poor English fluency \\[many study instruments are not validated in other languages\\]\n* expected survival \\<6 months per attending physician\n* ICU length of stay \\>30 days\n* lack of either:\n* reliable or sufficient smartphone with cellular data plan or\n* reliable computer online access plus telephone access\n* unable to complete study procedures as determined by study staff\n* discharge to a location other than a home setting\n* complex medical care expected soon after discharge (e.g., multiple planned surgeries, transplantation evaluation (including outpatient daily cardiopulmonary rehabilitation), extensive travel needs for hemodialysis, disruptive chemotherapy or XRT regimen, etc)\n\nOther issues relevant to the consent process:\n\n* unable to approach patient for logistical reasons (e.g., off ward in test at time of approach, etc)\n* patient discharged before consent could be obtained\n* patient dies before consent obtained\n\nPatient exclusion criteria present after consent but before randomization:\n\nAfter providing informed consent, patients will become ineligible if any of the following are present:\n\n* they become too ill to participate (or die)\n* they exhibit significant cognitive disability\n* they exhibit suicidality\n* patient was unexpectedly discharged to location other than a home setting and then did not arrive home within 1 month from hospital discharge"}, 'identificationModule': {'nctId': 'NCT02701361', 'briefTitle': 'Mobile Mindfulness to Improve Psychological Distress After Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Mobile Mindfulness to Improve Psychological Distress After Critical Illness', 'orgStudyIdInfo': {'id': 'Pro00064250'}, 'secondaryIdInfos': [{'id': 'R34AT008819', 'link': 'https://reporter.nih.gov/quickSearch/R34AT008819', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Education group', 'description': 'A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.', 'interventionNames': ['Behavioral: education']}, {'type': 'EXPERIMENTAL', 'label': 'Standard mindfulness', 'description': 'Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.', 'interventionNames': ['Behavioral: standard mindfulness']}, {'type': 'EXPERIMENTAL', 'label': 'Mobile mindfulness', 'description': 'Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.', 'interventionNames': ['Behavioral: mobile mindfulness']}], 'interventions': [{'name': 'mobile mindfulness', 'type': 'BEHAVIORAL', 'description': 'Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.', 'armGroupLabels': ['Mobile mindfulness']}, {'name': 'standard mindfulness', 'type': 'BEHAVIORAL', 'description': 'Receives weekly calls from mindfulness expert for 4 weeks.', 'armGroupLabels': ['Standard mindfulness']}, {'name': 'education', 'type': 'BEHAVIORAL', 'description': 'Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.', 'armGroupLabels': ['Education group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Christopher E Cox, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}