NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Virtual Group Therapy for IBD Patients With Anxiety and Depression
Virtual Group Therapy for IBD Patients With Anxiety and Depression

NCT07796568

Not Yet RecruitingNA

Sponsor: University of Chicago

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

Interventions: Group Psychotherapy Intervention

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (1)
  • Chicago, Illinois, United States