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Digital Health Interventions for Obsessive Compulsive Disorder (OCD)

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Obsessive-Compulsive Disorder

Treatments

Device: Perspectives OCD
Device: The Health and Well-Being Program

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04136626
2018P001669

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Perspectives OCD
Experimental group
Description:
12 week Smartphone-delivered cognitive behavioral therapy (CBT) for OCD.
Treatment:
Device: Perspectives OCD
The Health and Well-Being Program
Active Comparator group
Description:
12 week health and well-being education
Treatment:
Device: The Health and Well-Being Program

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Jennifer Greenberg, Psy.D.; Simay Ipek, BA

Data sourced from clinicaltrials.gov

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