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Managing Stress With Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Disease, Anxiety, Depression

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring cognitive behavioral therapy, online intervention

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with inflammatory bowel disease - Crohn's disease or ulcerative colitis
  • A score on a scale measuring perceived stress, anxiety or depression indicating the presence of a clinically significant problem
  • Regular access to a personal computer and Internet to allow access to the program
  • Ability to read and write English

Exclusion Criteria:

  • Presence of significant suicidal ideation or suicidal intent within the last six months
  • Presence of self-harming behavior in the last six months
  • Currently active substance use disorder (last six months)
  • Psychotic disorder (last six months)
  • Eating disorder (last six months)

Sites / Locations

  • University of Manitoba - College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cognitive Behavioral Therapy

Arm Description

Online cognitive behavioral therapy intervention for 2 hours a week for 12 weeks.

Outcomes

Primary Outcome Measures

Change in Hospital Anxiety and Depression Scale (HADS)
scale measuring anxiety and depression (14 items); likert scale 0 (not at all) to 3 (most of the time); higher scores(summed) indicate presence of anxiety or depression
Change in Perceived Stress Scale 4 (PSS-4)
scale measuring psychological stress (4 items); likert scale 0 (never) to 4 (very often); higher scores indicate higher levels of perceived stress

Secondary Outcome Measures

Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
scale measuring health-related quality of life (29 items); likert scale 1 to 5, varying anchor points; in symptom oriented domains higher scores represent worse symptomology and in function oriented domains higher scores represent better functioning
Change in Clinical Global Impression - Improvement scale (CGI-I)
scale measuring confidence in ability to manage stress (2 items); likert scale with varying anchor points; higher scores indicate higher stress and lower confidence
Change in the Work and Social Adjustment Scale (WSAS)
scale measuring how inflammatory bowel disease impact daily functioning; likert scale 1(not at all) to 5 (very severely); higher scores indicate higher levels higher functional impairment
Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI)
scale measuring symptoms of inflammatory bowel disease; likert scale with varying anchor points

Full Information

First Posted
August 1, 2018
Last Updated
September 27, 2021
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT03852745
Brief Title
Managing Stress With Inflammatory Bowel Disease
Official Title
Managing Stress With Inflammatory Bowel Disease - an Open Trial of a Web-based Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

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

5. Study Description

Brief Summary
This study will recruit persons with Inflammatory Bowel Disease. The investigators will contact people in an ongoing study (called IMAGINE) to recruit persons with high levels of stress, anxiety, or depression who are interested in a web-based program focused on skills in managing stress, anxiety and depression (a self-directed psychosocial intervention). The goal is to develop an internet-based psychosocial intervention to help persons with inflammatory bowel disease to cope with high levels of stress, anxiety or depression.
Detailed Description
Depression and anxiety are highly prevalent in IBD, with depression rates almost twice as high for those with IBD compared to the general community, and an estimated 30% overall with depression or anxiety. Perceived stress is a factor in the development of anxiety and depression. These comorbid conditions complicate management of IBD, adversely impacting patient outcomes and health, and increasing the resource burden to the health care system. However, comorbid depression and anxiety in IBD patients is undertreated, paralleling unmet mental health treatment needs in the general Canadian population. Development of alternate modes of effective treatment delivery is vital to enhance access, given limited mental health service availability. CBT has strong clinical evidence for its effectiveness in treating episodes of depression and anxiety as well as in preventing relapses. CBT may be successfully delivered as an internet-based intervention. While there are limited data on the efficacy of CBT tailored to the IBD population, studies targeting comorbid depression in IBD have resulted in significant mental health improvement. A recent study described an internet-based CBT for IBD reported modest outcomes (150), but participants were not selected to have psychiatric comorbidity and the primary outcomes were not improvement in mood or anxiety symptoms. The internet-based program used in this study will involve brief modules focused on areas important in managing stress, anxiety and depression including: Core Topics: 1. About the Program, 2. IBD and Stress 3. Commitment to Living Life Fully, 4. The Brain-Gut Connection, 5. Understanding Anxiety, 6. Overcoming Avoidance, 7. Depression, 8. Behavioural Activation; Optional Topics: 9. Treatment Options, 10. IBD and the Workplace 11. Mindfulness Procedures: Participants will be recruited with the use of a resources informing possible participants about the project. Patients expressing an interest in the program will receive a copy of the consent form for the study by email but asked not to sign it. They will be asked to schedule a time with the study coordinator to review with consent form, discuss any questions about the consent form or the program, and at the end to indicate verbally whether or not they provide consent. Those who provide consent will complete a brief psychiatric interview with the study coordinator to check for inclusion and exclusion criteria. The interview used will be the Mini International Neuropsychiatric Interview (MINI) for DSM5. Those who meet the inclusion criteria for the study will be sent a survey link to complete a the baseline measures for the program.Once participants are accepted into the study assessments will be completed at baseline, week 6, week 12, and during follow up at week 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Anxiety, Depression
Keywords
cognitive behavioral therapy, online intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cognitive behavior therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Other
Arm Description
Online cognitive behavioral therapy intervention for 2 hours a week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
cognitive behavioral therapy; focus on learning skills including acceptance and commitment
Primary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
scale measuring anxiety and depression (14 items); likert scale 0 (not at all) to 3 (most of the time); higher scores(summed) indicate presence of anxiety or depression
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Change in Perceived Stress Scale 4 (PSS-4)
Description
scale measuring psychological stress (4 items); likert scale 0 (never) to 4 (very often); higher scores indicate higher levels of perceived stress
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
Description
scale measuring health-related quality of life (29 items); likert scale 1 to 5, varying anchor points; in symptom oriented domains higher scores represent worse symptomology and in function oriented domains higher scores represent better functioning
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Change in Clinical Global Impression - Improvement scale (CGI-I)
Description
scale measuring confidence in ability to manage stress (2 items); likert scale with varying anchor points; higher scores indicate higher stress and lower confidence
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Change in the Work and Social Adjustment Scale (WSAS)
Description
scale measuring how inflammatory bowel disease impact daily functioning; likert scale 1(not at all) to 5 (very severely); higher scores indicate higher levels higher functional impairment
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks
Title
Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI)
Description
scale measuring symptoms of inflammatory bowel disease; likert scale with varying anchor points
Time Frame
Baseline, 6 weeks, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with inflammatory bowel disease - Crohn's disease or ulcerative colitis A score on a scale measuring perceived stress, anxiety or depression indicating the presence of a clinically significant problem Regular access to a personal computer and Internet to allow access to the program Ability to read and write English Exclusion Criteria: Presence of significant suicidal ideation or suicidal intent within the last six months Presence of self-harming behavior in the last six months Currently active substance use disorder (last six months) Psychotic disorder (last six months) Eating disorder (last six months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Furer, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba - College of Medicine
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0W2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Managing Stress With Inflammatory Bowel Disease

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