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Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Diseases, Psychological Distress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based Cognitive Behavioral Therapy
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Hutchinson CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-based Cognitive Behavioral Therapy

Arm Description

Outcomes

Primary Outcome Measures

Recruitment Rate
Proportion of eligible patients who enroll into the trial
Adherence Rate
Number of activities and weekly sessions completed

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2022
Last Updated
July 13, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05413941
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Psychological Distress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet-based Cognitive Behavioral Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Internet-based Cognitive Behavioral Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Proportion of eligible patients who enroll into the trial
Time Frame
8 weeks
Title
Adherence Rate
Description
Number of activities and weekly sessions completed
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Illness Perception
Description
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)
Time Frame
8 weeks
Title
Self-efficacy
Description
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)
Time Frame
8 weeks
Title
Coping
Description
Manner of dealing with stress measured via Brief Resilient Coping Scale (minimum 4, maximum 20; higher scores indicate greater resilience)
Time Frame
8 weeks
Title
Crohn's Activity
Description
Level of symptomatic disease measured via Short Crohn's Disease Activity index
Time Frame
8 weeks
Title
Ulcerative Colitis Activity
Description
Level of symptomatic disease measured via Simple Clinical Colitis Activity index
Time Frame
8 weeks
Title
Interleukin-6 level
Description
Inflammatory biomarker
Time Frame
8 weeks
Title
Health related quality of life
Description
Quality of life measured via PROMIS-29 questionnaire (mean T score is 50, higher scores indicate higher degree of measured trait)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruby Greywoode, MD
Phone
347-671-8205
Email
rgreywoode@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Benitez
Phone
347-429-0253
Email
sheila.benitez@einsteinmed.edu
Facility Information:
Facility Name
Montefiore Hutchinson Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruby Greywoode, MD
Phone
347-671-8205
Email
rgreywoode@montefiore.org

12. IPD Sharing Statement

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Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease

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