Clinical trial NCT03767491: Waitlist-Control Trial of Smartphone CBT for Obsessive-Compulsive Disorder (OCD)
Official title: Smartphone Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder: A Randomized, Waitlist-control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Telefónica S.A.
First posted: 2018-12-06
Enrollment: 0
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 the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for obsessive compulsive disorder (OCD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in Y-BOCS scores than those in the waitlist condition at treatment endpoint (week 12).

Detailed description: The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with OCD recruited nationally. Eligible subjects (N=58) will be randomly assigned to 12 weeks of Smartphone-delivered CBT for OCD either immediately, or after a 12-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for OCD will be feasible and acceptable to individuals with OCD, and that it will lead to greater reductions in OCD symptom severity compared to the passage of time (waitlist control).

Eligibility criteria: 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
* 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
* 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 severity (Y-BOCS) at the end of treatment/waitlist period.
timeFrame: Endpoint (week 12)
Secondary outcomes:
measure: Difference in depression at the end of treatment/waitlist period
timeFrame: Endpoint (week 12)
measure: Difference in functional impairment at the end of treatment/waitlist period
timeFrame: Endpoint (week 12)
measure: Difference in quality of life at the end of treatment/waitlist period
timeFrame: Endpoint (week 12)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Anna Schwartzberg
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References: