An interventional study of Group Psychotherapy Intervention in Crohn's Disease (CD), Ulcerative Colitis (UC) and Inflammatory Bowel Diseases (IBD), sponsored by University of Chicago. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University of Chicago · Not applicable, Interventional, and Treatment
Among 660 studies in Crohn Disease with a site in United States — 122 open to participants now, 163 under way, 35 of them phase 3. Crohn Disease · United States.
Among the 660 studies in Crohn Disease with a site in United States, this one is the 413th largest by planned enrollment of the 528 interventional ones that give a count, is one of 35 that started in 2026, is one of 128 with no phase, reaches primary completion later than 61 of the 162 other live ones, and was the 659th registered.
1,992 studies on the registry are indexed under Crohn Disease; 477 are open to participants now.
Browse Crohn Disease studies →122 of the 660 studies in Crohn Disease with a site in United States are open now. Recruiting first, the newest first:
Shattuck Labs, Inc. · Sites in United States
Ages 18–80
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Sites in United States
Ages 18–85
Agomab Spain S.L.U. · Sites in United States, Serbia, United Kingdom
Ages 18+
University of Miami · Sites in United States
Ages 16–75
The Cleveland Clinic · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 353 Crohn Disease studies recruiting now, 154 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 95 take children under 18; 56 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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660 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 86 · Phase 2 179 · Phase 3 134 · Phase 4 41
First in 1995; this study’s year is marked. 35 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 16 is below the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Median enrollment 60 across the 528 interventional studies, 168 across the 128 observational. Of the 452 that completed or were terminated, 205 (45%) have results posted.
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310 of 660 have an industry lead sponsor. The 10 most frequent:
University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
University of Chicago has 2 studies filed under Crohn Disease — fewer than ten, so there is no comparison to draw.
59 of the studies in Crohn Disease with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06063967Phase 3AbbVieA Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. | 2027-03 |
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT05660746Phase 3Children's Hospital Medical Center, CincinnatiPrecise Infliximab Exposure and Pharmacodynamic Control | 2027-03-31 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT06227910Phase 3TakedaA Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease | 2027-06-08 |
Add all 59 to your calendar (.ics) → With an account.
Among the 660 studies in Crohn Disease with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Group Psychotherapy Intervention
Participants 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.
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
Acceptability will be assessed using the Client Satisfaction Questionnaire-4 (CSQ-4), which is used to measure overall satisfaction and client self-efficacy in healthcare, mental health, and social programs. Scores range from 4-16, with higher scores indicating higher satisfaction with the treatment. CSQ-4 scores are commonly classified as "low satisfaction/dissatisfaction" (4-8), "moderate/neutral satisfaction" (9-12), and "high satisfaction" (13-16).
Time frame: End of intervention at week 10
Determine feasibility 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
Feasibility will be assessed by analyzing recruitment and retention (i.e., number of patients who are referred that enroll in the study and complete treatment)
Time frame: End of treatment at 10 weeks
Change in depression
Measured via Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report tool used to screen, diagnose, and measure the severity of depression in clinical settings. It scores depressive symptoms experienced over the past two weeks on a scale from 0 to 27, with higher scores indicating more severe symptoms. Scores are commonly classified as "minimal or no depression" (0-4), "mild depression" (5-9), "moderate depression" (10-14), "moderately severe depression" (15-19), and "severe depression" (20-27).
Time frame: Before, during, and after treatment (weeks 0, 5, and 10).
Change in anxiety
Measured via Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report tool used to screen for anxiety and measure its severity over the past two weeks. Scores range from 0-21, with higher numbers indicating more severe symptoms. GAD-7 scores are commonly classified as "minimal anxiety" (0-4), "mild anxiety" (5-9), "moderate anxiety" (10-14), and "severe anxiety" (15-21).
Time frame: Before, during, and after treatment (weeks 0, 5, and 10).
Change in fatigue
Measured via Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), 13-item tool that measures tiredness and how it affects daily life over the past 7 days. Scores range from 0-52, with higher numbers indicating less fatigue. FACIT-Fatigue scores are commonly classified as "severe fatigue" (0-21), "moderate fatigue" (22-30), "mild fatigue" (31-40), and "little to no fatigue" (40-52).
Time frame: Before, during, and after treatment (weeks 0, 5, and 10).
Change in sleep quality
Measured via Pittsburgh Sleep Quality Index (PSQI), 19-item self-report questionnaire that evaluates subjective sleep quality and disturbances over a one-month time period. Scores range from 0-21, with higher numbers indicating worse sleep quality. PSQI scores are commonly classified as "good sleep quality" (0-5) and "poor sleep quality" (6-21).
Time frame: Before, during, and after treatment (weeks 0, 5, and 10).
Change in gastrointestinal symptom-specific anxiety (GSA)
Measured via Visceral Sensitivity Index (VSI), a 15-item self-report questionnaire that evaluates GSA, including fear, hypervigilance, and avoidance of belly sensations. Scores range from 0-75, with higher numbers indicating worse GSA.
Time frame: Before, during, and after treatment (weeks 0, 5, and 10).
Change in clinical IBD outcomes (CD)
Measured for patients with CD via change in scores on the Harvey Bradshaw Index (HBI), a clinical tool used to measure the severity of CD based on five patient symptoms from the previous day. Scores range from 0-16 and up, with higher numbers indicating more severe disease activity. HBI scores are commonly classified as "clinical remission" (0-4), "mild disease activity" (5-7), "moderate disease activity" (8-16), and "severe disease activity" (16 or more).
Time frame: Before, during, and after treatment (weeks 0, 5, and 10).
Change in clinical IBD outcomes (UC)
Measured for patients with UC via change in scores on the Simple Clinical Colitis Activity Index (SCCAI), a clinical tool used to measure the severity of UC. Scores range from 0-5 and up, with higher numbers indicating more severe disease activity. UC scores are commonly classified as "clinical remission" (0-2), "mild disease activity" (3-4), and "active flare or relapse" (5 or more).
Time frame: Before, during, and after treatment (weeks 0, 5, and 10).
Change in biomedical IBD outcomes
Change in biochemical inflammation measured by fecal calprotectin and c-reactive protein levels.
Time frame: Before, during, and after treatment (weeks 0, 5, and 10).
Change in targeted metabolites including compounds from tryptophan metabolism
Change in untargeted metabolite levels
Time frame: Before, during, and after treatment (weeks 0, 5, and 10).
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
Of 288 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's planned 9 months is below that.
Counting every sponsor, half of 300 studies reached it within 45 months; a quarter within 21 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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