Clinical trial NCT04136626: Digital Health Interventions for Obsessive Compulsive Disorder (OCD)
Official title: Digital Health Interventions for Obsessive Compulsive Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
OCD
randomized controlled trial
digital health
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Koa Health B.V.
First posted: 2019-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in OCD Symptom Severity at the End of Week 12
timeFrame: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)
Secondary outcomes:
measure: Difference in Depression at the End of Week 12
timeFrame: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)
measure: Difference in Functional Impairment at the End of Week 12
timeFrame: Week 0, Week 6, and Week 12
measure: Difference in Quality of Life at the End of Week 12
timeFrame: Week 0, Week 6, and Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: