Digital Health Interventions for Obsessive Compulsive Disorder (OCD)

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04136626
• Other study ID #: 2018P001669
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: November 1, 2024
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• Perspectives OCD
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).
• The Health and Well-Being Program
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Koa Health B.V.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)