Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413941
• Other study ID #: 2022-14155
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Montefiore Medical Center
• Contact: Ruby Greywoode, MD
• Phone: 347-671-8205
• Email: rgreywoode[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Psychological Distress

Intervention

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).

Locations

Country	Name	City	State
United States	Montefiore Hutchinson Campus	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Proportion of eligible patients who enroll into the trial	8 weeks
Primary	Adherence Rate	Number of activities and weekly sessions completed	8 weeks
Secondary	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
Secondary	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
Secondary	Coping	Manner of dealing with stress measured via Brief Resilient Coping Scale (minimum 4, maximum 20; higher scores indicate greater resilience)	8 weeks
Secondary	Crohn's Activity	Level of symptomatic disease measured via Short Crohn's Disease Activity index	8 weeks
Secondary	Ulcerative Colitis Activity	Level of symptomatic disease measured via Simple Clinical Colitis Activity index	8 weeks
Secondary	Interleukin-6 level	Inflammatory biomarker	8 weeks
Secondary	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