Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammatory Bowel Diseases, Psychological Distress

Intervention / Treatment
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* Behavioral: Internet-based Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based Cognitive Behavioral Therapy<br> | Behavioral: Internet-based Cognitive Behavioral Therapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Proportion of eligible patients who enroll into the trial | 8 weeks | 
| Adherence Rate | Number of activities and weekly sessions completed | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Coping | Manner of dealing with stress measured via Brief Resilient Coping Scale (minimum 4, maximum 20; higher scores indicate greater resilience) | 8 weeks | 
| Crohn's Activity | Level of symptomatic disease measured via Short Crohn's Disease Activity index | 8 weeks | 
| Ulcerative Colitis Activity | Level of symptomatic disease measured via Simple Clinical Colitis Activity index | 8 weeks | 
| Interleukin-6 level | Inflammatory biomarker | 8 weeks | 
| 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 |