Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

Sponsor
Montefiore Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05413941
Collaborator
(none)
70
1
35

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet-based Cognitive Behavioral Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Internet-based Cognitive Behavioral Therapy for Black and Latino Patients With Inflammatory Bowel Disease
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Internet-based Cognitive Behavioral Therapy

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).

Outcome Measures

Primary Outcome Measures

  1. Recruitment Rate [8 weeks]

    Proportion of eligible patients who enroll into the trial

  2. Adherence Rate [8 weeks]

    Number of activities and weekly sessions completed

Secondary Outcome Measures

  1. Ilness Perception [8 weeks]

    Cognitive and emotional representations formed about one's illness measured via Brief Ilness Perception Questionnaire

  2. 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

  3. Coping [8 weeks]

    Manner of dealing with stress measured via Brief Resilient Coping Scale

  4. Crohn's Activity [8 weeks]

    Level of symptomatic disease measured via Short Crohn's Disease Activity index

  5. Ulcerative Colitis Activity [8 weeks]

    Level of symptomatic disease measured via Simple Clinical Colitis Activity index

  6. Interleukin-6 level [8 weeks]

    Inflammatory biomarker

  7. Health related quality of life [8 weeks]

    Quality of life measured via PROMIS-29 questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Montefiore Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruby Greywoode, Assistant Professor of Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT05413941
Other Study ID Numbers:
  • 2022-14155
First Posted:
Jun 10, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022