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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Ulcerative Colitis (UC)
• Intervention / Treatment: Behavioral: Psychologist-administered Cognitive Behavioral Therapy; Behavioral: Self-Administered Cognitive Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Gaidos, MD, FACG; Phone Number: 203-785-4138; Email: jill.gaidos@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• verified inflammatory bowel disease (Crohn's disease and ulcerative colitis)
• IBD patients on a stable treatment regimen with no evidence of active intestinal inflammation based on either normal c-reactive protein and/or fecal calprotectin, imaging studies, or endoscopy who meet the criteria for anxiety or depression based on the screening questionnaires
• subjects who have been on stable doses of anxiety and/or depression medications (defined as no dose adjustment in the prior 12 weeks) at the screening visit who meet the criteria for anxiety and/or depression based on screening questionnaires and are willing to stay on the same dose of these medications throughout the study duration
• may meet the criteria for both anxiety and depression and cohort assignment will be based on the survey with the highest scores suggesting more severe symptoms

Exclusion Criteria:

• declines to participate for the full duration of the study
• evidence of active intestinal inflammation based on an elevated c-reactive protein and/or fecal calprotectin, imaging studies or endoscopy
• non-English speaker
• any subject who expresses suicidal ideation or has severe mental illness as they will be taken to the emergency room for urgent psychiatric care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychologist-administered Cognitive Behavioral Therapy; Participants in this arm will participate in psychologist-administered CBT to assess the impact it will have on anxiety or depression among patients with inflammatory bowel disease	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.
Experimental: Self-administered Cognitive Behavioral Therapy; Participants in this arm will be given a patient education book that teaches how to self-administer cognitive behavioral therapy to assess the impact it will have on anxiety or depression among patients with inflammatory bowel disease	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in anxiety scores using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire	Change from baseline in anxiety using GAD-7 compared to week 6, week 12 and week 24 (post treatment). Generalized Anxiety Disorder-7 questionnaire is a 7-item validated questionnaire used to screen for anxiety with a range of scores from 0-3. A cumulative score of ≥8 is considered positive for anxiety with lower scores indicating no or mild anxiety.	baseline, week 6, week 12, week 24 and week 52
Change from baseline in depression scores using the Patient Health Questionnaire-9 (PHQ-9)	Change from baseline in depression using PHQ-9 compared to week 6, week 12 and week 24 (post treatment). PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.	baseline, week 6, week 12, week 24, and week 52

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Crohn's & Colitis Foundation of America (CCFA)
• Investigators: Principal Investigator: Jill Gaidos, MD, FACG, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: anxiety, depression
• Additional Relevant MeSH Terms: Intestinal Diseases; Behavioral Symptoms; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Depression; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: 2000031323; 878888 (Other Grant/Funding Number: Crohn's & Colitis Foundation of America (CCFA))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No