Virtual Group Therapy for IBD Patients With Anxiety and Depression

NCT07796568 | Not Yet Recruiting

• 1 other identifier: IRB26-0657
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn's Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Diseases (IBD); Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• 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).

  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)

  End of treatment at 10 weeks

Secondary Outcomes (9)

• Change in depression

  Before, during, and after treatment (weeks 0, 5, and 10).

• Change in anxiety

  Before, during, and after treatment (weeks 0, 5, and 10).

• Change in fatigue

  Before, during, and after treatment (weeks 0, 5, and 10).

• Change in sleep quality

  Before, during, and after treatment (weeks 0, 5, and 10).

• Change in gastrointestinal symptom-specific anxiety (GSA)

  Before, during, and after treatment (weeks 0, 5, and 10).

Study Arms (1)

Patients with IBD who self-report moderate or higher anxiety or depression symptoms

EXPERIMENTAL

Behavioral: Group Psychotherapy Intervention

Interventions

Group Psychotherapy Intervention BEHAVIORAL

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.

Patients with IBD who self-report moderate or higher anxiety or depression symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Patients with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
• English-speaking
• Patients with score ≥10 on General Anxiety Disorder-7 (GAD-7) questionnaire (considered moderate or higher anxiety symptoms) or ≥10 on the Patient Health Questionnaire-9 (PHQ-9) (considered moderate or higher depressive symptoms) within 3 months
• Able to provide written consent

You may not qualify if:

• Unwilling and/or unable to participate
• Non-English speakers
• Unable to understand the instructions or to consent to participation in the study, including patients with a diagnosed cognitive impairment

Sponsors & Collaborators

• University of Chicago: lead
• GI Research Foundation: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alyse Bedell, PhD, CST

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Study Coordinator

CONTACT

872-303-7886; Ela.Chintagunta@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)