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

NCT ID: NCT03767491

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-06-01

Brief Summary

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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

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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).

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Smartphone-delivered CBT for OCD

12-week Smartphone delivered CBT for OCD.

Group Type EXPERIMENTAL

Smartphone-delivered CBT for OCD

Intervention Type DEVICE

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.

12 Week Waitlist Control

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

Group Type OTHER

Smartphone-delivered CBT for OCD

Intervention Type DEVICE

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.

Interventions

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Smartphone-delivered CBT for OCD

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Telefónica S.A.

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sabine Wilhelm, PhD

Chief of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sabine Wilhelm, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Anna Schwartzberg

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2018P001669-a

Identifier Type: -

Identifier Source: org_study_id

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