Back to resultsDigital Health Interventions for Obsessive Compulsive Disorder (OCD)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perspectives OCD
The Health and Well-Being Program
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, OCD, randomized controlled trial, digital health
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Current diagnosis of primary DSM-5 OCD, based on MINI
- Currently living in the United States
Exclusion Criteria:
- Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
- Past participation in ≥4 sessions of CBT for OCD
- Past use of a CBT for OCD app
- Current severe substance use disorder
- Lifetime bipolar disorder or psychosis
- Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥2 on the suicidal ideation subscale of the C-SSRS.
- Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21
- Current post-traumatic stress disorder (PTSD)
- Concurrent psychological treatment
- Does not own a supported mobile Smartphone with a data plan
- Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Perspectives OCD
The Health and Well-Being Program
Arm Description
12 week Smartphone-delivered CBT for OCD.
12 week health and well-being education
Outcomes
Primary Outcome Measures
Difference in OCD severity (YBOCS) at the end of Week 12
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the gold-standard, semi-structured clinician-administered assessment of OCD severity. It contains 10 items ranging from 0 to 4, which are summed to generate a total score (range = 0-40). Higher scores indicate more severe OCD symptoms. The Y-BOCS will be used to assess change in OCD symptoms from baseline to endpoint.
Secondary Outcome Measures
Difference in depression at the end of Week 12
The QIDS-SR is a self-report measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.
Difference in functional impairment at the end of Week 12
The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.
Difference in quality of life at the end of Week 12
The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Full Information
NCT ID
NCT04136626
First Posted
October 17, 2019
Last Updated
October 10, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Koa Health B.V.
1. Study Identification
Unique Protocol Identification Number
NCT04136626
Brief Title
Digital Health Interventions for Obsessive Compulsive Disorder (OCD)
Official Title
Digital Health Interventions for Obsessive Compulsive Disorder: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
October 6, 2023 (Actual)
Study Completion Date
November 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Koa Health B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are testing two digital health interventions for obsessive compulsive disorder (OCD). The investigators hope that these digital health programs will increase access to treatment for OCD.
Detailed Description
The primary aims of this study are to test the feasibility, acceptability, and efficacy of two digital health interventions for adults with OCD recruited nationally. Eligible subjects (N=120) will be randomly assigned (50/50 chance) to 12 weeks of app-based CBT on their personal Smartphone or 12 weeks of web-based health and well-being education in addition to completing clinical assessments and questionnaires from home. All participants will have access to a coach to help guide them through their assigned program. Total participation time for the study is approximately 6 months, and all study appointments (5 total) occur over secure phone or video conference call.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, OCD, randomized controlled trial, digital health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perspectives OCD
Arm Type
Experimental
Arm Description
12 week Smartphone-delivered CBT for OCD.
Arm Title
The Health and Well-Being Program
Arm Type
Active Comparator
Arm Description
12 week health and well-being education
Intervention Type
Device
Intervention Name(s)
Perspectives OCD
Intervention Description
The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work) and behavioral skills (e.g., exposure and response prevention).
Intervention Type
Device
Intervention Name(s)
The Health and Well-Being Program
Intervention Description
The website includes 12 modules related to general health and well-being (e.g., sleep and nutrition). Each module contains educational information and questions about an indvidual's experience with the given topic.
Primary Outcome Measure Information:
Title
Difference in OCD severity (YBOCS) at the end of Week 12
Description
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the gold-standard, semi-structured clinician-administered assessment of OCD severity. It contains 10 items ranging from 0 to 4, which are summed to generate a total score (range = 0-40). Higher scores indicate more severe OCD symptoms. The Y-BOCS will be used to assess change in OCD symptoms from baseline to endpoint.
Time Frame
Endpoint (week 12)
Secondary Outcome Measure Information:
Title
Difference in depression at the end of Week 12
Description
The QIDS-SR is a self-report measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.
Time Frame
Endpoint (week 12)
Title
Difference in functional impairment at the end of Week 12
Description
The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.
Time Frame
Endpoint (week 12)
Title
Difference in quality of life at the end of Week 12
Description
The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Time Frame
Endpoint (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Current diagnosis of primary DSM-5 OCD, based on MINI
Currently living in the United States
Exclusion Criteria:
Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
Past participation in ≥4 sessions of CBT for OCD
Past use of a CBT for OCD app
Current severe substance use disorder
Lifetime bipolar disorder or psychosis
Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥2 on the suicidal ideation subscale of the C-SSRS.
Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21
Current post-traumatic stress disorder (PTSD)
Concurrent psychological treatment
Does not own a supported mobile Smartphone with a data plan
Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Digital Health Interventions for Obsessive Compulsive Disorder (OCD)
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