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Virtual Group Therapy for IBD Patients With Anxiety and Depression

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 11 weeks
  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether online group talk therapy is practical and acceptable for adults with inflammatory bowel disease (IBD) and moderate or worse anxiety or depression. IBD causes swelling and irritation in the digestive tract. Participants attend 3 in-person visits and 10 online group sessions over 11 weeks, fill out surveys, and give blood and stool samples.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have Crohn’s disease or ulcerative colitis, two types of IBD.
  • Speak English.
  • Have a score of 10 or higher on the GAD-7 anxiety survey or PHQ-9 depression survey within the past 3 months. These scores mean moderate or worse symptoms.
  • Can give written consent to join the study.

Who can't join

  • Are unwilling or unable to take part.
  • Do not speak English.
  • Cannot understand the instructions or give consent, including because of a diagnosed problem with thinking or memory.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

IL