Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

Montefiore Medicine Academic Health System

Status: Withdrawn

Conditions: Inflammatory Bowel Diseases; Psychological Distress

Treatments: Behavioral: Internet-based Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05413941

2022-14155

K12TR004411 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Internet-based Cognitive Behavioral Therapy

Experimental group

Treatment:

Behavioral: Internet-based Cognitive Behavioral Therapy