Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease
- Conditions
- Psychological DistressInflammatory Bowel Diseases
- Interventions
- Behavioral: Internet-based Cognitive Behavioral Therapy
- Registration Number
- NCT05413941
- Lead Sponsor
- Montefiore Medical Center
- 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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- severe psychological distress
- active suicidality, past suicide attempt, or psychiatric hospitalization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Internet-based Cognitive Behavioral Therapy Internet-based Cognitive Behavioral Therapy -
- Primary Outcome Measures
Name Time Method Recruitment Rate 8 weeks Proportion of eligible patients who enroll into the trial
Adherence Rate 8 weeks Number of activities and weekly sessions completed
- Secondary Outcome Measures
Name Time Method Coping 8 weeks Manner of dealing with stress measured via Brief Resilient Coping Scale (minimum 4, maximum 20; higher scores indicate greater resilience)
Illness Perception 8 weeks 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)
Self-efficacy 8 weeks 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)
Crohn's Activity 8 weeks Level of symptomatic disease measured via Short Crohn's Disease Activity index
Interleukin-6 level 8 weeks Inflammatory biomarker
Ulcerative Colitis Activity 8 weeks Level of symptomatic disease measured via Simple Clinical Colitis Activity index
Health related quality of life 8 weeks Quality of life measured via PROMIS-29 questionnaire (mean T score is 50, higher scores indicate higher degree of measured trait)
Trial Locations
- Locations (1)
Montefiore Hutchinson Campus
🇺🇸Bronx, New York, United States