Virtual Group Therapy for IBD Patients With Anxiety and Depression
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Chicago
- Study ID
- NCT07796568
- Status
- Not Yet Recruiting
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Conditions
- Anxiety
- Crohn's Disease (CD)
- Depression
- Inflammatory Bowel Diseases (IBD)
- Ulcerative Colitis (UC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Group Psychotherapy Intervention — BEHAVIORALParticipants will engage in a course of ten, 120-minute sessions of group psychotherapy. The intervention will be guided by the Mind Over Mood treatment manual. Mind Over Mood is a manual that is published and commonly used to treat depression and anxiety as guided by a therapist and for self-help. For this study, the manual will be adapted for patients with IBD. Session content will include interventions such as psychoeducation on the brain-gut connection and the CBT model, behavioral activation and activity scheduling, cognitive monitoring and restructuring, development of behavioral experiments to test underlying assumptions, building acceptance and gratitude, and maintenance of gains and relapse prevention.
Study Details
This study is being done to better understand the complex relationship between mental health and Inflammatory Bowel Disease (IBD), with a particular focus on symptoms of depression and anxiety. While depression and anxiety have traditionally been viewed as reactions to the burden of living with IBD, new research suggests that the biological factors involved in IBD may also contribute directly to these mental health challenges. This study aims to evaluate whether a virtual, group-based psychological treatment is both acceptable and feasible for patients with IBD who experience significant depression and/or anxiety. Researchers will also evaluate participants' depression, generalized anxiety, and associated psychosocial factors (poor sleep quality, GI-specific anxiety, fatigue) before, during, and after treatment. Finally, researchers will evaluate disease severity as it relates to mental health status by comparing it to symptoms, biochemical disease and tryptophan metabolites from blood and stool samples. People who agree to join the study will be asked to attend three in-person visits and 10 virtual group psychotherapy sessions over 11 weeks. Participants will be asked to complete questionnaires, give stool and blood samples, and the research team will collect information about participations from medical records.
Key Dates
- First listed
- Sep 1, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 16 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Patients with IBD who self-report moderate or higher anxiety or depression symptoms
Primary Outcome Measure
Determine acceptability of a 10-session, group-based, virtual treatment guided by the Mind over Mood treatment manual in patients with IBD with clinically significant depression and/or anxiety [ Time Frame: End of intervention at week 10 ]
Central Contacts
- Lead Study Coordinator872-303-7886
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | Alyse Bedell, PhD, CST (PRINCIPAL_INVESTIGATOR) |
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