Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

Not Applicable

Withdrawn

• Conditions: Psychological Distress; Inflammatory Bowel Diseases

• Registration Number: NCT05413941
• Lead Sponsor: Montefiore Medical Center

Brief Summary

While people of color are an increasing segment of the inflammatory bowel disease (IBD) population, they are currently underrepresented in research, including studies of psychological distress. Appreciation for psychological distress (anxiety, depression, perceived stress) as a driver of IBD activity has led to increased efforts to integrate psychological interventions into IBD medical care. Cognitive behavioral therapy (CBT) is the most studied psychotherapeutic approach in IBD and the one that suggests improvements in mental health and quality of life in those with elevated psychological distress. There are unanswered questions in the use of CBT in IBD: how to leverage digital technology to deliver CBT through internet-based cognitive behavioral therapy (iCBT); how do we consider the social context of individuals from racial and ethnic minority groups who may experience distinct social and structural barriers to acceptance and use of psychological interventions? Thus, this study will qualitatively analyze how factors, such as digital access, mental health stigma, and lived experience with IBD and as racial or ethnic minority influence attitudes toward mental health and iCBT in a cohort of Black and Latino IBD patients with elevated psychological distress. Results will lead to adaptation of a CBT program into an iCBT app to be tested for acceptance/use and to explore effects on psychological and disease-related factors.

Detailed Description

The clinical trial component of this study (Aim 3) was never conducted. Only Aim 1, consisting of an assessment of the factors influencing acceptance and use of iCBT via semi-structured interviews, and which did not meet the definition of a clinical trial, was conducted as part of this study. The clinical trial component associated with this study, the internet-based cognitive therapy (iCBT), is being conducted as part of the "Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease (DMBI)," NCT06510296 (ID: 2024-16064) clinical trial.

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-10
• Study Start: 2022-09-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• self-identify as Black or Hispanic/Latino
• diagnosis of Crohn's disease or ulcerative colitis
• ability to provide informed consent in English
• basic computer skills (i.e. ability to self-complete online questionnaire)
• elevated psychological distress

Exclusion Criteria

• severe psychological distress
• active suicidality, past suicide attempt, or psychiatric hospitalization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	8 weeks	Proportion of eligible patients who enroll into the trial
Adherence Rate	8 weeks	Number of activities and weekly sessions completed

Secondary Outcome Measures

Name	Time	Method
Coping	8 weeks	Manner of dealing with stress measured via Brief Resilient Coping Scale (minimum 4, maximum 20; higher scores indicate greater resilience)
Illness Perception	8 weeks	Cognitive and emotional representations formed about one's illness measured via Brief Illness Perception Questionnaire (minimum 0, maximum 80; higher scores indicate more severe illness impact)
Self-efficacy	8 weeks	A task-specific construct of the perception of one's ability to manage a given situation measured via PROMIS-Self Efficacy in Managing Emotions questionnaire (T score 50 is the mean, higher scores indicate greater self efficacy)
Crohn's Activity	8 weeks	Level of symptomatic disease measured via Short Crohn's Disease Activity index
Interleukin-6 level	8 weeks	Inflammatory biomarker
Ulcerative Colitis Activity	8 weeks	Level of symptomatic disease measured via Simple Clinical Colitis Activity index
Health related quality of life	8 weeks	Quality of life measured via PROMIS-29 questionnaire (mean T score is 50, higher scores indicate higher degree of measured trait)

Trial Locations

Locations (1)

Montefiore Hutchinson Campus; 🇺🇸 Bronx, New York, United States