NCT05377840

Use of Psychologist-administered Cognitive Behavioral Therapy (CBT) or Self-administered CBT for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)

Effect Cognitive Behavioral Therapy (CBT) in the Treatment of Anxiety and Depression in Patients With Inflammatory Bowel Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single center, randomized treatment study to assess if anxiety and depression in participants with IBD can be improved with CBT compared to those treated with SKY.

Detailed description

This is a prospective, single center, randomized treatment study, where participants will be screened for anxiety and depression in an inflammatory bowel disease (Crohn's disease and ulcerative colitis) population using the Generalized Anxiety Disorder (GAD) questionnaire and the Patient Health Questionnaire (PHQ). Participants with GAD scores of ≥8 will be considered to have anxiety and those with a PHQ score of ≥10 will be considered to have depression. All participants with screening questionnaire scores positive for anxiety or depression will be randomized to treatment with either cognitive behavioral therapy (CBT) with a clinical psychologist (virtual visits) or CBT using a book written for IBD patients. The GAD and PHQ surveys will be repeated post treatment at weeks 6, 12 and 24. The primary objective of this study is to assess for an improvement in GAD and PHQ scores among subjects treated with CBT comparing 2 modalities of CBT. The secondary objectives are to assess for improvements in health-related quality of life, based on short IBD Questionnaire scores; assess for improvement in pain scores, based on the Brief Pain Inventory Short Form; and assess for improvement in fatigue scores based on the FACIT-Fatigue Scale, among subjects with poor scores at baseline following treatment with CBT.

Conditions

• Crohn Disease
• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
BEHAVIORAL	Psychologist-administered Cognitive Behavioral Therapy	CBT is a combined psycho-social intervention that aims to improve overall mental health focusing on developing coping strategies. For psychologist-administered CBT: Participants will have individual weekly sessions (virtually) lasting 60 minutes each over an 8-week period with 1 follow-up maintenance session at week 12.
BEHAVIORAL	Self-Administered Cognitive Behavioral Therapy	CBT is a combined psycho-social intervention that aims to improve overall mental health focusing on developing coping strategies. For self-administered CBT: Participants will be given a book written for patients on CBT for IBD with instructions on how to self-administer CBT.

Timeline

• Start date: 2022-07-05
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-05-17
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States