Virtual Group Therapy for Inflammatory Bowel Disease

LS
Overseen ByLead Study Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AB

Alyse Bedell, PhD, CST

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis) who are also experiencing significant anxiety and/or depression. Participants must be able to attend virtual group sessions and a few in-person visits.

Inclusion Criteria

English-speaking
I have Crohn's disease or ulcerative colitis.
Patients with score ≥10 on General Anxiety Disorder-7 (GAD-7) questionnaire or ≥10 on the Patient Health Questionnaire-9 (PHQ-9) within 3 months
See 2 more

Exclusion Criteria

I am not willing or able to take part in the study.
Non-English speakers
I am unable to understand study instructions or give consent due to cognitive issues.

What Are the Treatments Tested in This Trial?

Interventions

  • Group Psychotherapy Intervention

Trial Overview

The study is testing whether virtual group therapy helps people with IBD manage symptoms of anxiety and depression. Over 11 weeks, participants join online group psychotherapy sessions, complete surveys, and provide blood and stool samples.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Patients with IBD who self-report moderate or higher anxiety or depression symptomsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

GI Research Foundation

Collaborator

Trials
1
Recruited
20+