Digital Health Interventions for Obsessive Compulsive Disorder (OCD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Digital Health Interventions for Obsessive Compulsive Disorder: A Randomized Controlled Trial

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: Perspectives OCD
* Device: The Health and Well-Being Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perspectives OCD<br>12 week Smartphone-delivered CBT for OCD. | Device: Perspectives OCD<br>* 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).<br>|
| Active Comparator: The Health and Well-Being Program<br>12 week health and well-being education | Device: The Health and Well-Being Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Endpoint (week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Endpoint (week 12) | 
| 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. | Endpoint (week 12) | 
| 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). | Endpoint (week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive-Compulsive Disorder, OCD, randomized controlled trial, digital health