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Digital Behavioral Interventions in Inflammatory Bowel Disease

Primary Purpose

Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet based cognitive behavioral therapy
Digital mood tracking
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

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

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

Sites / Locations

  • Montefiore Hutchinson Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internet-based cognitive behavioral therapy

Digital mood tracking

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Anxiety and/or depression
Level of psychological distress measured by the sub-score domains of anxiety and/or depression on the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 assessment tool (minimum score 4, maximum score 20; higher scores indicate higher anxiety or depression).

Secondary Outcome Measures

Perceived Stress Score
Level of perceived stress as measured by the National Institutes of Health Perceived Stress Scale (minimum 14, maximum 75; higher scores indicate higher perceived stress)
Health-related Quality-of-Life
Health-related Quality-of-Life as measured by the overall National Institutes of Health Patient Reported Outcomes Measurement Information System-29
Crohn's Disease Activity
Measured by Short Crohn's Disease Activity Index in individuals with Crohn's disease (minimum 0, maximum 600; higher scores indicate more disease activity)
Ulcerative Colitis Disease Activity
Measured by partial Mayo Score (minimum 0, maximum 6; higher score indicates more disease activity) in individuals with ulcerative colitis

Full Information

First Posted
April 12, 2021
Last Updated
May 31, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04861597
Brief Title
Digital Behavioral Interventions in Inflammatory Bowel Disease
Official Title
Digital Behavioral Interventions in Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 22, 2023 (Actual)
Study Completion Date
March 22, 2023 (Actual)

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, Stress, Psychological, Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based cognitive behavioral therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Digital mood tracking
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet based cognitive behavioral therapy
Intervention Description
Participants with elevated psychological distress will receive 8 weeks of internet-based cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Digital mood tracking
Intervention Description
Participants with elevated psychological distress will receive 8 weeks of digital mood tracking
Primary Outcome Measure Information:
Title
Anxiety and/or depression
Description
Level of psychological distress measured by the sub-score domains of anxiety and/or depression on the National Institutes of Health Patient Reported Outcomes Measurement Information System-29 assessment tool (minimum score 4, maximum score 20; higher scores indicate higher anxiety or depression).
Time Frame
4 weeks post-intervention
Secondary Outcome Measure Information:
Title
Perceived Stress Score
Description
Level of perceived stress as measured by the National Institutes of Health Perceived Stress Scale (minimum 14, maximum 75; higher scores indicate higher perceived stress)
Time Frame
4 weeks post-intervention
Title
Health-related Quality-of-Life
Description
Health-related Quality-of-Life as measured by the overall National Institutes of Health Patient Reported Outcomes Measurement Information System-29
Time Frame
4 weeks post-intervention
Title
Crohn's Disease Activity
Description
Measured by Short Crohn's Disease Activity Index in individuals with Crohn's disease (minimum 0, maximum 600; higher scores indicate more disease activity)
Time Frame
4 weeks post-intervention
Title
Ulcerative Colitis Disease Activity
Description
Measured by partial Mayo Score (minimum 0, maximum 6; higher score indicates more disease activity) in individuals with ulcerative colitis
Time Frame
4 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruby Greywoode, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Hutchinson Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29366841
Citation
Gracie DJ, Guthrie EA, Hamlin PJ, Ford AC. Bi-directionality of Brain-Gut Interactions in Patients With Inflammatory Bowel Disease. Gastroenterology. 2018 May;154(6):1635-1646.e3. doi: 10.1053/j.gastro.2018.01.027. Epub 2018 Jan 31.
Results Reference
background
PubMed Identifier
26841224
Citation
Mikocka-Walus A, Knowles SR, Keefer L, Graff L. Controversies Revisited: A Systematic Review of the Comorbidity of Depression and Anxiety with Inflammatory Bowel Diseases. Inflamm Bowel Dis. 2016 Mar;22(3):752-62. doi: 10.1097/MIB.0000000000000620.
Results Reference
background
PubMed Identifier
25934170
Citation
Mikocka-Walus A, Bampton P, Hetzel D, Hughes P, Esterman A, Andrews JM. Cognitive-behavioural therapy has no effect on disease activity but improves quality of life in subgroups of patients with inflammatory bowel disease: a pilot randomised controlled trial. BMC Gastroenterol. 2015 May 2;15:54. doi: 10.1186/s12876-015-0278-2.
Results Reference
background

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Digital Behavioral Interventions in Inflammatory Bowel Disease

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