Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 7:00 AM
Study NCT ID:
NCT05612750
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2022-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and research staff will know arm assignment. Co-investigators, project statisticians, and the protocol director at each study site will remain blinded until final assessment.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A pragmatic clinical trial randomizing to one of two (standard of care) online group behavioral treatments: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1650}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2022-08-05', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Outcome Health Service Utilization', 'timeFrame': '6 months', 'description': 'We will utilize EMR and database records to compare treatment groups for healthcare utilization (e.g., medical visits) during final 3 months of the study vs. 3 months prior to enrollment.'}], 'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '1 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)'}, {'measure': 'Pain Intensity', 'timeFrame': '2 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)'}, {'measure': 'Pain Intensity', 'timeFrame': '3 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)'}, {'measure': 'Pain Intensity', 'timeFrame': '6 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)'}, {'measure': 'Pain Interference', 'timeFrame': '1 month', 'description': 'Compare study treatments for primary outcomes post-treatment with the Numeric Rating Scale (0-10)'}, {'measure': 'Pain Interference', 'timeFrame': '2 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.'}, {'measure': 'Pain Interference', 'timeFrame': '3 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.'}, {'measure': 'Pain Interference', 'timeFrame': '6 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS Pain Interference 6-item scale.'}], 'secondaryOutcomes': [{'measure': 'Sleep Disturbance', 'timeFrame': '1 month', 'description': 'Compare treatment groups on the PROMIS Sleep Disturbance 6-item'}, {'measure': 'Sleep Disturbance', 'timeFrame': '2 months', 'description': 'Compare treatment groups on the PROMIS Sleep Disturbance 6-item'}, {'measure': 'Sleep Disturbance', 'timeFrame': '3 months', 'description': 'Compare treatment groups on the PROMIS Sleep Disturbance 6-item'}, {'measure': 'Sleep Disturbance', 'timeFrame': '6 months', 'description': 'Compare treatment groups on the PROMIS Sleep Disturbance 6-item'}, {'measure': 'Pain Bothersomeness', 'timeFrame': '1 month', 'description': 'Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)'}, {'measure': 'Pain Bothersomeness', 'timeFrame': '2 months', 'description': 'Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)'}, {'measure': 'Pain Bothersomeness', 'timeFrame': '3 months', 'description': 'Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)'}, {'measure': 'Pain Bothersomeness', 'timeFrame': '6 months', 'description': 'Compare treatment groups for Pain Bothersomeness on a Numeric Rating Scale (0-10)'}, {'measure': 'Pain Catastrophizing', 'timeFrame': '1 months', 'description': 'Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.'}, {'measure': 'Pain Catastrophizing', 'timeFrame': '2 months', 'description': 'Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.'}, {'measure': 'Pain Catastrophizing', 'timeFrame': '3 months', 'description': 'Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. We aim to obtain \\>30% reduction in PCS scores after the intervention'}, {'measure': 'Pain Catastrophizing', 'timeFrame': '6 months', 'description': 'Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.'}, {'measure': 'Anxiety', 'timeFrame': '1 month', 'description': 'Compare treatment groups for anxiety using the PROMIS Anxiety 6-item'}, {'measure': 'Anxiety', 'timeFrame': '2 months', 'description': 'Compare treatment groups for anxiety using the PROMIS Anxiety 6-item'}, {'measure': 'Anxiety', 'timeFrame': '3 months', 'description': 'Compare treatment groups for anxiety using the PROMIS Anxiety 6-item'}, {'measure': 'Anxiety', 'timeFrame': '6 months', 'description': 'Compare treatment groups for anxiety using the PROMIS Anxiety 6-item'}, {'measure': 'Satisfaction with Social Roles/Responsibilities', 'timeFrame': '1 month', 'description': 'Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities'}, {'measure': 'Satisfaction with Social Roles/Responsibilities', 'timeFrame': '2 months', 'description': 'Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities'}, {'measure': 'Satisfaction with Social Roles/Responsibilities', 'timeFrame': '3 months', 'description': 'Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities'}, {'measure': 'Satisfaction with Social Roles/Responsibilities', 'timeFrame': '6 months', 'description': 'Compare treatment groups for PROMIS 6 item Satisfaction with Social Roles/Responsibilities'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': '1months', 'description': 'Compare treatment groups for PROMISE 1 item Global Impression of Change scale'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': '2 month', 'description': 'Compare treatment groups for PROMISE 1 item Global Impression of Change scale'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': '3 months', 'description': 'Compare treatment groups for PROMISE 1 item Global Impression of Change scale'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': '6 months', 'description': 'Compare treatment groups for PROMISE 1 item Global Impression of Change scale'}, {'measure': 'Depression', 'timeFrame': '1 month', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.'}, {'measure': 'Depression', 'timeFrame': '2 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.'}, {'measure': 'Depression', 'timeFrame': '3 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.'}, {'measure': 'Depression', 'timeFrame': '6 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Depression scale.'}, {'measure': 'Fatigue', 'timeFrame': '1 month', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.'}, {'measure': 'Fatigue', 'timeFrame': '2 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.'}, {'measure': 'Fatigue', 'timeFrame': '3 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.'}, {'measure': 'Fatigue', 'timeFrame': '6 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 6 item Fatigue scale.'}, {'measure': 'Anger', 'timeFrame': '1 month', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.'}, {'measure': 'Anger', 'timeFrame': '2 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.'}, {'measure': 'Anger', 'timeFrame': '3 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.'}, {'measure': 'Anger', 'timeFrame': '6 months', 'description': 'Compare study treatments for primary outcomes post-treatment with the PROMIS 5 item Anger scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Young adult', 'Lupus', 'Pelvic Pain', 'Behavioral Health'], 'conditions': ['Pain, Chronic', 'Lupus', 'Pelvic Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment time).', 'detailedDescription': 'The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness: (1) 8-session cognitive behavioral therapy for chronic pain (pain-CBT); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief). The investigators aim to understand for patients which treatment works best.\n\nOnline evidence-based behavioral treatment for pain will greatly expand access to patients across the U.S. living with diverse chronic pain conditions. Results from this study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care.\n\nThis study will provide a low-cost, relatively low-risk, widely available and feasible protocol that directly addresses the needs of millions of community-based outpatients and their physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age or older of either sex (and all genders).\n2. Chronic pain (pain that occurs on at least half of the days of 3 months or more).\n3. Past-month average pain intensity score of at least 3/10.\n4. Ability to adhere to and complete study protocols.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent.\n2. Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study including group treatment.\n3. Active suicidality at screening.\n4. Study staff may exclude individuals with a known history of disruptive behavior to minimize contamination of the learning environment for an entire treatment cohort.\n5. Receipt of either study treatment in the past 3 months.'}, 'identificationModule': {'nctId': 'NCT05612750', 'acronym': 'PROGRESS', 'briefTitle': 'Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparative Effectiveness of Online Cognitive Behavioral Therapy vs. An Online Single-Session Pain Relief Skills Class for Chronic Pain - The PROGRESS Study', 'orgStudyIdInfo': {'id': 'IRB-65439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lupus Chronic Pain Cohort', 'description': '150 participants with Lupus and Chronic Pain', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)', 'Behavioral: Empowered Relief']}, {'type': 'EXPERIMENTAL', 'label': 'Chronic Pelvic Pain', 'description': '150 participants with Chronic Pelvic Pain', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)', 'Behavioral: Empowered Relief']}, {'type': 'EXPERIMENTAL', 'label': 'Young Adult (18-23) Chronic Pain', 'description': '150 participants ages 18-23 with Chronic Pain', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)', 'Behavioral: Empowered Relief']}, {'type': 'EXPERIMENTAL', 'label': 'PRIME Sample', 'description': '1200 participants with chronic pain', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)', 'Behavioral: Empowered Relief']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.', 'armGroupLabels': ['Chronic Pelvic Pain', 'Lupus Chronic Pain Cohort', 'PRIME Sample', 'Young Adult (18-23) Chronic Pain']}, {'name': 'Empowered Relief', 'type': 'BEHAVIORAL', 'description': 'A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.', 'armGroupLabels': ['Chronic Pelvic Pain', 'Lupus Chronic Pain Cohort', 'PRIME Sample', 'Young Adult (18-23) Chronic Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ken Cook, CCRC', 'role': 'CONTACT', 'email': 'arthur.cook@va.gov', 'phone': '602.277.5551', 'phoneExt': '2451'}, {'name': 'Aram Mardian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eric Hanson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Phoenix VA Health Care System', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabby Riazi, MPH', 'role': 'CONTACT', 'email': 'g.riazi@scanhealthplan.com', 'phone': '(562) 308-5880', 'phoneExt': '5880'}, {'name': 'Gabrielle Riazi, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SCAN Health Plan', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arayam Hailu, BS', 'role': 'CONTACT', 'email': 'arayamyh@stanford.edu', 'phone': '650-887-4497'}, {'name': 'Jackie Miefert, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Quanli Chen, MS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Humana', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Heggan, BS', 'role': 'CONTACT', 'email': 'elizabeth_a.heggan@lvhn.org'}, {'name': 'Steve Denton, LCSW', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lehigh Valley Health Network', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Haroldsen', 'role': 'CONTACT'}, {'name': 'Joel Porter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Intermountain Healthcare', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Emma A Adair, BS', 'role': 'CONTACT', 'email': 'eadair@stanford.edu', 'phone': '6097448937'}, {'name': 'Corinne Jung, PhD', 'role': 'CONTACT', 'email': 'Cejung@stanford.edu', 'phone': '(650) 724-0522'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Beth Darnall', 'investigatorAffiliation': 'Stanford University'}}}}