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Crohn's Disease (CD)NCT07796568

Virtual Group Therapy for IBD Patients With Anxiety and Depression

A study testing Group Psychotherapy Intervention in people with Crohn's Disease (CD) and Ulcerative Colitis (UC), run by University of Chicago at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Group Psychotherapy Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Sep 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18+ 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lead Study Coordinator contact

872-303-7886

Ela.Chintagunta@bsd.uchicago.edu

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

    Lead Study Coordinator, 872-303-7886, Ela.Chintagunta@bsd.uchicago.edu

    Alyse Bedell, PhD, CST

Other trials in United States

About this study

Official title: Group-based Virtual Psychotherapy Intervention for Anxiety and Depression in Patients With Inflammatory Bowel Disease

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.

Being tested
Group Psychotherapy Intervention
Medical subject headings
Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Psychotherapy InterventionBehavioural

    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.

Study groups in NCT07796568
Study groupRoleWhat they receive
Patients with IBD who self-report moderate or higher anxiety or depression symptomsExperimentalNot described
Receives: Behavioral: Group Psychotherapy Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: End of intervention at week 10

  2. 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)

    Measured: End of treatment at 10 weeks

Secondary outcomes (9)

  1. 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).

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

  2. 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).

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

  3. 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).

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

  4. 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).

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

  5. 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.

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

  6. 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).

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

  7. 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).

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

  8. Change in biomedical IBD outcomes

    Change in biochemical inflammation measured by fecal calprotectin and c-reactive protein levels.

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

  9. Change in targeted metabolites including compounds from tryptophan metabolism

    Change in untargeted metabolite levels

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07796568
Sponsor's protocol ID
IRB26-0657
Status last verified
Aug 2026
First submitted
24 Aug 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group Psychotherapy Intervention in people with Crohn's Disease (CD) and Ulcerative Colitis (UC), run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lead Study Coordinator (872-303-7886, Ela.Chintagunta@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07796568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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