Clinical trial NCT05413941: Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease
Official title: Internet-based Cognitive Behavioral Therapy for Black and Latino Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Psychological Distress
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-06-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: 8 weeks
measure: Adherence Rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Illness Perception
timeFrame: 8 weeks
measure: Self-efficacy
timeFrame: 8 weeks
measure: Coping
timeFrame: 8 weeks
measure: Crohn's Activity
timeFrame: 8 weeks
measure: Ulcerative Colitis Activity
timeFrame: 8 weeks
measure: Interleukin-6 level
timeFrame: 8 weeks
measure: Health related quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Hutchinson Campus
state: New York
Study officials:
References: