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Completed

NCT Number: 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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline in anxiety scores using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire

    Time frame: baseline, week 6, week 12, week 24 and week 52

    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.

  2. Change from baseline in depression scores using the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: baseline, week 6, week 12, week 24, and week 52

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Crohn's & Colitis Foundation of America (CCFA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 17, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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