Clinical trial 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)
Official title: Effect Cognitive Behavioral Therapy (CBT) in the Treatment of Anxiety and Depression in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Ulcerative Colitis (UC)
Keywords: anxiety, depression
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Crohn's & Colitis Foundation of America (CCFA)
First posted: 2022-05-17
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in anxiety scores using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire
timeFrame: baseline, week 6, week 12, week 24 and week 52
measure: Change from baseline in depression scores using the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, week 6, week 12, week 24, and week 52
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Jill Gaidos, MD, FACG
role: PRINCIPAL_INVESTIGATOR
References: