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)

NCT05377840 | Recruiting DMC

• 2 other identifiers: 2000031323878888
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease; Ulcerative Colitis (UC)

Keywords

anxiety, depression

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Psychologist-administered Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Self-administered Cognitive Behavioral Therapy

EXPERIMENTAL

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

Interventions

Psychologist-administered Cognitive Behavioral Therapy BEHAVIORAL

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.

Psychologist-administered Cognitive Behavioral Therapy

Self-Administered Cognitive Behavioral Therapy BEHAVIORAL

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.

Self-administered Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Crohn's & Colitis Foundation of America (CCFA): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

Related Publications (1)

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jill Gaidos, MD, FACG

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Gaidos, MD, FACG

CONTACT

203-785-4138; jill.gaidos@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this prospective, single center, randomized treatment study, participants will be screening for anxiety and depression in an inflammatory bowel disease population (Crohn's disease and ulcerative colitis) using the Generalized Anxiety Disorder (GAD) questionnaire and the Patient Health Questionnaire (PHQ). Subjects 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 subjects with screening questionnaire scores positive for anxiety or depression will be randomized to treatment with either psychologist-administered or self-administered cognitive behavioral therapy (CBT).

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: July 5, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

US (1)