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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone-delivered CBT for OCD
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anna Schwartzberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Smartphone-delivered CBT for OCD

12 Week Waitlist Control

Arm Description

12-week Smartphone delivered CBT for OCD.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Difference in depression at the end of treatment/waitlist period
Participants who receive app-CBT will have greater improvement on depression (QIDS-SR). The QIDS-SR is a self-report measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.
Difference in functional impairment at the end of treatment/waitlist period
Participants who receive app-CBT will have greater improvement on functional impairment (SDS). The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.
Difference in quality of life at the end of treatment/waitlist period
Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).

Full Information

First Posted
December 5, 2018
Last Updated
August 4, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Telefónica S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03767491
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study must be registered under the sponsor instead of the site, so we have created a new posting in the sponsor's account.
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Telefónica S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone-delivered CBT for OCD
Arm Type
Experimental
Arm Description
12-week Smartphone delivered CBT for OCD.
Arm Title
12 Week Waitlist Control
Arm Type
Other
Arm 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).
Intervention Type
Device
Intervention Name(s)
Smartphone-delivered CBT for OCD
Intervention 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.
Primary Outcome Measure Information:
Title
Difference in OCD severity (Y-BOCS) at the end of treatment/waitlist period.
Description
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.
Time Frame
Endpoint (week 12)
Secondary Outcome Measure Information:
Title
Difference in depression at the end of treatment/waitlist period
Description
Participants who receive app-CBT will have greater improvement on depression (QIDS-SR). The QIDS-SR is a self-report measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.
Time Frame
Endpoint (week 12)
Title
Difference in functional impairment at the end of treatment/waitlist period
Description
Participants who receive app-CBT will have greater improvement on functional impairment (SDS). The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.
Time Frame
Endpoint (week 12)
Title
Difference in quality of life at the end of treatment/waitlist period
Description
Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Time Frame
Endpoint (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anna Schwartzberg
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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