Waitlist-Control Trial of Smartphone CBT for Obsessive-Compulsive Disorder (OCD)

Smartphone Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder: A Randomized, Waitlist-control Trial

Sponsors

Lead Sponsor: Massachusetts General Hospital

Collaborator: Telefónica S.A.

Source Massachusetts General Hospital
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).

Overall Status Withdrawn
Start Date 2019-07-01
Completion Date 2022-06-01
Primary Completion Date 2022-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Difference in OCD severity (Y-BOCS) at the end of treatment/waitlist period. Endpoint (week 12)
Secondary Outcome
Measure Time Frame
Difference in depression at the end of treatment/waitlist period Endpoint (week 12)
Difference in functional impairment at the end of treatment/waitlist period Endpoint (week 12)
Difference in quality of life at the end of treatment/waitlist period Endpoint (week 12)
Condition
Intervention

Intervention Type: Device

Intervention Name: Smartphone-delivered CBT for OCD

Description: 12-week Smartphone-delivered CBT for OCD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for OCD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Sabine Wilhelm, PhD Principal Investigator Massachusetts General Hospital
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Anna Schwartzberg
Location Countries

United States

Verification Date

2020-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Massachusetts General Hospital

Investigator Full Name: Sabine Wilhelm, PhD

Investigator Title: Chief of Psychology

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Smartphone-delivered CBT for OCD

Type: Experimental

Description: 12-week Smartphone delivered CBT for OCD.

Label: 12 Week Waitlist Control

Type: Other

Description: 12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for OCD following the 12-week waitlist control).

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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