Digital Behavioral Interventions in Inflammatory Bowel Disease

August 21, 2024 updated by: Montefiore Medical Center
Given the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (IBD), whereby increased psychological distress exacerbates disease activity and vice versa, psychosocial aspects of IBD care are receiving increased attention. However, proposed interventions are generally resource-intensive and have been tested in majority white populations. While people of color are an increasing segment of the IBD population, they are currently underrepresented in research studies. The purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (iCBT) among IBD patients of color with elevated psychological distress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators propose a 1:1 randomized trial design to evaluate the efficacy of iCBT among a population of Black and Latinx IBD patients and to assess factors influencing its implementation. Patients within the integrated health system at Montefiore Medical Center will be actively recruited and screened to identify those with elevated psychological distress.

Eligible patients will be randomized to receive 8 weeks of iCBT or digital mood tracking to evaluate the effect of iCBT on levels of psychological distress, HRQoL and disease activity post-intervention. The investigators will also evaluate individual process level barriers and facilitators to iCBT implementation via surveys and semi-structured interviews.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Hutchinson Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age ≥ 18 years
  • race/ethnicity self-identified as Black/African American or Hispanic/Latino
  • established diagnosis of Crohn's disease or ulcerative colitis
  • elevated psychological distress: at least one T-score within two standard deviations above the mean in the domains of anxiety or depression on the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) with or without a T-score within two standard deviations above the mean for perceived stress on the National Institute of Health Toolbox Perceived Stress Scale (Perceived Stress Scale)
  • internet access (smartphone/mobile device with data plan, computer with internet)
  • ability to provide informed consent in English or Spanish

Exclusion Criteria:

  • PROMIS-29 anxiety or depression T-scores in the severe range (above 2 standard deviations)
  • Current suicidal ideation, past suicidal attempt or hospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based cognitive behavioral therapy
The iCBT platform selected for use in this study (Sanvello™) is an evidence-based mobile app created by clinical experts that has been shown to decrease depression, anxiety, and stress and to increase self-efficacy in a non-IBD population.15 App features include: daily mood tracking; guided journeys (e.g. psychoeducational content providing background information about cognitive behavioral therapy and instructing users on how to use app tools to maintain motivation and interest); coping tools (e.g. meditation, goal setting, and negative thought redirecting activities); weekly progress assessments; community support board.
Behavioral: Internet based cognitive behavioral therapy
Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy
Active Comparator: Digital mood tracking
The digital mood tracking application (app) selected for this study (PixelTM) allows participants to log their mood each day by way of a facial expression emoji and a free-text box. This app is commercially available free of charge through iOS and Android app stores with English and Spanish language options.
Behavioral: Digital mood tracking
Participants with elevated psychological distress will receive 8 weeks of digital mood tracking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Psychological Distress
Time Frame: Post-4 week trial intervention
Level of psychological distress in participants over the prior 7 days was measured by combining the sub-score domains of anxiety and depression from the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) assessment tool. PROMIS-29 is a 29-item form that includes 4 questions in each of the domains of anxiety and depression. Group mean scores of these 8 items are composited. Higher scores indicate a greater level of the measured trait, and raw scores are converted to a T-score that centers at a mean of 50 with a standard deviation of 10 in the general population.
Post-4 week trial intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Activity by Short Crohn's Disease Activity Index
Time Frame: Post-4 week trial intervention
Disease activity over the prior 7 days for Crohn's disease patients will be measured using the Short Crohn's Disease Activity Index (sCDAI). The sCDAI consists of three variables identified as predictors of disease activity: diarrhea frequency (number of liquid or soft stools), abdominal pain, and general well-being. Scoring was calculated as follows to calculate an overall score: 44 + (2 x the number of liquid or soft stools each day for 7 days) + 5 x the sum of seven daily abdominal pain ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) + 7 x the sum of seven general well-being ratings (0 = generally well, 1 = slightly under par, 2 = poor, 3 = very poor, 4 = terrible). Overall scoring ranged from 44 to an undefined upper limit based on diarrhea frequency with increasing scores being indicative of more Crohn's disease activity. Group scores were summarized using basic descriptive statistics.
Post-4 week trial intervention
Disease Activity by Simple Clinical Colitis Activity Index
Time Frame: Post-4 week trial intervention
Disease activity over the prior 7 days in Ulcerative Colitis patients will be measured using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., uveitis, pyoderma gangrenosum, erythema nodusum, and arthropathy). Scores are summarized for an overall possible scoring range of 0-19 with increasing scores being indicative of more colitis activity. Group scores were summarized using basic descriptive statistics.
Post-4 week trial intervention
Perceived Stress Score
Time Frame: Post-4 week trial intervention
Level of perceived stress in IBD patients was measured using the NIH Toolbox Item Bank/Fixed Form v2.0. This form consists of 10 questions or statements used to assess perceptions of stress in IBD patients over the past month. Responses to the 10 items are scored on a 5-point Likert scale ranging from 1 ("Never") to 5 ("Very Often"). Raw scores are auto-converted to a T-score that centers at a mean score of 50 with a Standard Deviation (SD) of 10. Higher scores are indicative of higher levels of the trait (perceived stress). Group scores were summarized using basic descriptive statistics.
Post-4 week trial intervention
Health-related Quality-of-Life
Time Frame: Post-4 week trial intervention
Health-related Quality-of-Life as measured by the overall National Institutes of Health Patient Reported Outcomes Measurement Information System-29
Post-4 week trial intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Ruby Greywoode, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

March 22, 2023

Study Completion (Actual)

March 22, 2023

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 25, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-12896
  • UL1TR002556 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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