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

NCT03767491 | Withdrawn DMC FDA Device

• 1 other identifier: 2018P001669-a
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Difference in OCD severity (Y-BOCS) at the end of treatment/waitlist period.

  The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the gold-standard, semi-structured clinician-administered assessment of OCD severity. It contains 10 items ranging from 0 to 4, which are summed to generate a total score (range = 0-40). Higher scores indicate more severe OCD symptoms. The Y-BOCS will be used to assess change in OCD symptoms from baseline to endpoint.

  Endpoint (week 12)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Smartphone-delivered CBT for OCD

EXPERIMENTAL

12-week Smartphone delivered CBT for OCD.

Device: Smartphone-delivered CBT for OCD

12 Week Waitlist Control

OTHER

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

Device: Smartphone-delivered CBT for OCD

Interventions

Smartphone-delivered CBT for OCD 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; Smartphone-delivered CBT for OCD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age
• current diagnosis of primary DSM-5 OCD, based on MINI
• currently living in the United States

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Telefónica S.A.: collaborator

Study Sites (1)

Anna Schwartzberg

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Sabine Wilhelm, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychology

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: July 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 8, 2022

Record last verified: 2020-05

Locations

US (1)