Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-25 @ 12:08 AM
Study NCT ID:
NCT06646757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-03
First Post:
2024-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IBD-related disability based on the validated IBD-Disability Index', 'timeFrame': '12 weeks', 'description': 'The study seeks to identify any changes in IBD-related disability pre-post intervention (week 0 and week 12) as measured by the IBD Disability Index (IBD-DI). IBD-related disability is measured by the validated 14-item IBD-disability index (yes-no responses and 1-5 point Likert scales) for limitations across 5 domains of International Classification of Functioning, Health, and Disability. Higher score indicates more disability. Total score ranges from 0-100, interpreted as 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability), and 50-100 (severe disability).'}], 'secondaryOutcomes': [{'measure': 'Change in IBD self-efficacy as measured by the IBD Self-Efficacy Scale Wasson Health Confidence Scale', 'timeFrame': '12 weeks', 'description': 'The study seeks to identify any changes in IBD self-efficacy as measured in the 13-item IBD-Self Efficacy Wasson Health Confidence Scale. This is one survey. A higher score indicates more confidence in self-efficacy and health confidence relative to chronic illness. Total score ranges from 0-130'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis (UC)', 'Crohn Disease (CD)']}, 'descriptionModule': {'briefSummary': "EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four multimodal behavioral interventions to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy. The interventions are four existing, publicly available disease-specific self-help resources offered at no cost to the participants: a book, smart app, help center, and peer mentor. Participants will complete online surveys and may engage in virtual focus groups. Participants may receive an honorarium (e-gift card) and/or be entered into a lottery for a giftcards post-survey completion and focus group participation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related (IBD) Disability Index score \\> 35 26,27)\n2. Able to consent, complete surveys, and participate in focus groups in English.\n\nExclusion Criteria:\n\n1. No/low disability (IBD-DI \\< 35) on the baseline survey\n2. Inability or unwillingness to participate in the interventions\n3. Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)\n4. Limited English proficiency (necessary because some interventions are currently only offered in English)'}, 'identificationModule': {'nctId': 'NCT06646757', 'acronym': 'EMPOWER-IBD', 'briefTitle': 'Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability', 'orgStudyIdInfo': {'id': '853060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm 1', 'description': 'No resource provision'}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': "Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \\& Colitis Foundation", 'interventionNames': ['Behavioral: PEER']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': "IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost", 'interventionNames': ['Behavioral: HELP']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': "IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \\& Colitis Foundation", 'interventionNames': ['Behavioral: HELP', 'Behavioral: PEER']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': '"Coping with Crohn\'s and Colitis: A Patient and Clinician\'s Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)', 'interventionNames': ['Behavioral: CBT']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6', 'description': '"Coping with Crohn\'s and Colitis: A Patient and Clinician\'s Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)\n\nPower of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn\'s \\& Colitis Foundation', 'interventionNames': ['Behavioral: CBT', 'Behavioral: PEER']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7', 'description': '"Coping with Crohn\'s and Colitis: A Patient and Clinician\'s Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn\'s and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost', 'interventionNames': ['Behavioral: CBT', 'Behavioral: HELP']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 8', 'description': '"Coping with Crohn\'s and Colitis: A Patient and Clinician\'s Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy) IBD Help Center (HELP) is a resource operated by the Crohn\'s and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn\'s \\& Colitis Foundation', 'interventionNames': ['Behavioral: CBT', 'Behavioral: HELP', 'Behavioral: PEER']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 9', 'description': "1\\) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs", 'interventionNames': ['Behavioral: APP']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 10', 'description': "My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs\n\nPower of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \\& Colitis Foundation", 'interventionNames': ['Behavioral: APP', 'Behavioral: PEER']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 11', 'description': "My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs\n\nIBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost", 'interventionNames': ['Behavioral: APP', 'Behavioral: HELP']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 12', 'description': "My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs\n\nIBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost\n\nPower of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \\& Colitis Foundation", 'interventionNames': ['Behavioral: APP', 'Behavioral: HELP', 'Behavioral: PEER']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 13', 'description': 'My IBD Care (APP) is a free smartapp that supports patients\' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs\n\n"Coping with Crohn\'s and Colitis: A Patient and Clinician\'s Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)', 'interventionNames': ['Behavioral: APP', 'Behavioral: CBT']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 14', 'description': 'My IBD Care (APP) is a free smartapp that supports patients\' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs\n\n"Coping with Crohn\'s and Colitis: A Patient and Clinician\'s Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)\n\nPower of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn\'s \\& Colitis Foundation', 'interventionNames': ['Behavioral: APP', 'Behavioral: CBT', 'Behavioral: PEER']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 15', 'description': 'My IBD Care (APP) is a free smartapp that supports patients\' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs\n\n"Coping with Crohn\'s and Colitis: A Patient and Clinician\'s Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)\n\nIBD Help Center (HELP) is a resource operated by the Crohn\'s and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost', 'interventionNames': ['Behavioral: APP', 'Behavioral: CBT', 'Behavioral: HELP']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 16', 'description': '1. My IBD Care (APP) is a free smartapp that supports patients\' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs\n2. "Coping with Crohn\'s and Colitis: A Patient and Clinician\'s Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)\n3. IBD Help Center (HELP) is a resource operated by the Crohn\'s and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost\n4. Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn\'s \\& Colitis Foundation', 'interventionNames': ['Behavioral: APP', 'Behavioral: CBT', 'Behavioral: HELP', 'Behavioral: PEER']}], 'interventions': [{'name': 'APP', 'type': 'BEHAVIORAL', 'description': "1\\) My IBD Care (APP) is a free smartapp that supports patients' tracking of symptoms, medical appointments, and medications; self-paced behavioral change programs", 'armGroupLabels': ['Arm 10', 'Arm 11', 'Arm 12', 'Arm 13', 'Arm 14', 'Arm 15', 'Arm 16', 'Arm 9']}, {'name': 'CBT', 'type': 'BEHAVIORAL', 'description': '2\\) "Coping with Crohn\'s and Colitis: A Patient and Clinician\'s Guide to CBT for IBD" (CBT) is an IBD-specific cognitive behavioral therapy (CBT) workbook (e-book or hardcopy)', 'armGroupLabels': ['Arm 13', 'Arm 14', 'Arm 15', 'Arm 16', 'Arm 5', 'Arm 6', 'Arm 7', 'Arm 8']}, {'name': 'HELP', 'type': 'BEHAVIORAL', 'description': "3\\) IBD Help Center (HELP) is a resource operated by the Crohn's and Colitis Foundation (CCF) for individuals to connect with an information specialist via email, call, or online live chat at no cost", 'armGroupLabels': ['Arm 11', 'Arm 12', 'Arm 15', 'Arm 16', 'Arm 3', 'Arm 4', 'Arm 7', 'Arm 8']}, {'name': 'PEER', 'type': 'BEHAVIORAL', 'description': "4\\) Power of Two (PEER) is a one-on-one peer mentoring program operated by the Crohn's \\& Colitis Foundation", 'armGroupLabels': ['Arm 10', 'Arm 12', 'Arm 14', 'Arm 16', 'Arm 2', 'Arm 4', 'Arm 6', 'Arm 8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}