Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

NCT ID: NCT05413941

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2025-06-30

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.

Conditions

Inflammatory Bowel Diseases; Psychological Distress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Internet-based Cognitive Behavioral Therapy

Group Type: EXPERIMENTAL

Internet-based Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruby Greywoode, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Other Identifiers

K12TR004411

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022-14155

Identifier Type: -

Identifier Source: org_study_id