Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

Internet-based Cognitive Behavioral Therapy for Black and Latino Patients With Inflammatory Bowel Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Inflammatory Bowel Diseases; Psychological Distress
• Intervention / Treatment: Behavioral: Internet-based Cognitive Behavioral Therapy

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Hutchinson Campus
      • Contact: Ruby Greywoode, MD; Phone Number: 347-671-8205; Email: rgreywoode@montefiore.org

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based Cognitive Behavioral Therapy	Behavioral: Internet-based Cognitive Behavioral Therapy; Cognitive behavioral therapy (CBT) is a form of psychotherapy in which individuals are taught to identify and modify maladaptive thinking and behavior to improve their psychological status and coping skills. CBT in this trial will be delivered digitally (internet-based).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	Proportion of eligible patients who enroll into the trial	8 weeks
Adherence Rate	Number of activities and weekly sessions completed	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illness Perception	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)	8 weeks
Self-efficacy	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)	8 weeks
Coping	Manner of dealing with stress measured via Brief Resilient Coping Scale (minimum 4, maximum 20; higher scores indicate greater resilience)	8 weeks
Crohn's Activity	Level of symptomatic disease measured via Short Crohn's Disease Activity index	8 weeks
Ulcerative Colitis Activity	Level of symptomatic disease measured via Simple Clinical Colitis Activity index	8 weeks
Interleukin-6 level	Inflammatory biomarker	8 weeks
Health related quality of life	Quality of life measured via PROMIS-29 questionnaire (mean T score is 50, higher scores indicate higher degree of measured trait)	8 weeks

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Ruby Greywoode, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 2022-14155; K12TR004411 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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