Recruiting

Cognitive Behavioral Therapy

Sponsor:

Montefiore Medical Center

Code:

NCT05413941

Conditions

Inflammatory Bowel Diseases

Psychological Distress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internet-based Cognitive Behavioral Therapy

Study Details

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.

Conditions

Inflammatory Bowel Diseases

Psychological Distress

Study ID

NCT05413941

Start date

Sep 26, 2022

Status verified date

Jul, 2024

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Internet-based Cognitive Behavioral Therapy

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).

Primary outcome measure

  • Recruitment Rate [ Time Frame: 8 weeks ]
  • Adherence Rate [ Time Frame: 8 weeks ]

Central Contacts and Locations

Locations

Montefiore Hutchinson Campus

Recruiting

Bronx, New York, United States, 10461

Contacts

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 8, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2024-07-08.