Digital Health Interventions for Obsessive Compulsive Disorder (OCD)

NCT04136626 | Completed Results DMC FDA Device

• 1 other identifier: 2018P001669
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; OCD; randomized controlled trial; digital health

Outcome Measures

Primary Outcomes (1)

• Difference in OCD Symptom Severity at the End of Week 12

  Symptom severity for OCD was measured with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), 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 to 40). Higher scores indicate more severe OCD symptoms.

  Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)

Secondary Outcomes (3)

• Difference in Depression at the End of Week 12

  Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)

• Difference in Functional Impairment at the End of Week 12

  Week 0, Week 6, and Week 12

• Difference in Quality of Life at the End of Week 12

  Week 0, Week 6, and Week 12

Study Arms (2)

Perspectives OCD

EXPERIMENTAL

12 week Smartphone-delivered cognitive behavioral therapy (CBT) for OCD.

Device: Perspectives OCD

The Health and Well-Being Program

ACTIVE COMPARATOR

12 week health and well-being education

Device: The Health and Well-Being Program

Interventions

Perspectives OCD DEVICE

The app-delivered cognitive behavioral therapy (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).

Perspectives OCD

The Health and Well-Being Program DEVICE

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.

The Health and Well-Being Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Current diagnosis of primary obsessive compulsive disorder (OCD), based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Mini International Neuropsychiatric Interview (MINI)
• Currently living in the United States

You may not qualify if:

• 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 cognitive behavioral therapy (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 Columbia Suicide Severity Rating Scale (C-SSRS).
• Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology, self-report version (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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Koa Health B.V.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Wilhelm S, Greenberg JL, Jacoby RJ, Weingarden H, Hoeppner SS, Klare D, Snorrason I, Jaroszewski AC, McCoy TH, Harrison O. A randomized clinical trial of app cognitive behavior therapy vs. HealthWatch for obsessive compulsive disorder. NPJ Digit Med. 2025 Dec 15;8(1):800. doi: 10.1038/s41746-025-02230-9.

  PMID: 41398456 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Sabine Wilhelm, Chief of Psychology
• Organization: Massachusetts General Hospital

swilhelm@mgh.harvard.edu

617-724-6146

Study Officials

• Sabine Wilhelm, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychology

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 23, 2019
• Study Start: July 26, 2021
• Primary Completion: October 6, 2023
• Study Completion: October 25, 2024
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-11

Locations

US (1)