Randomized Controlled Trial of Standard ERP and OC-Go (OC-GoPhaseII)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure and Response Prevention
OC-Go
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- Ages 9-17 years old
- Primary diagnosis of OCD based on diagnostic interview (ADIS)
- CGI-Severity score > 3
Exclusion Criteria:
- Anti-OCD medication/unstable dose (with changes expected during the study)
- Significant and interfering comorbid psychiatric, psychosocial, neurological, or medical condition (e.g., acute suicidality, low IQ, etc.) precluding the child's ability to complete all study procedures
Sites / Locations
- Univ. of California / Los Angeles / Semel Inst.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment-As-Usual
OC-Go
Arm Description
Individuals receiving treatment as usual will be receiving exposure and response prevention (ERP), the standard of care for pediatric OCD.
Individuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application.
Outcomes
Primary Outcome Measures
Homework compliance
Homework Compliance (%; range 0-100) = (Total homework assignments completed treatment weeks 2-11/Total homework assignments assigned weeks 2-11) * 100
Secondary Outcome Measures
Clinical Global Impression - Improvement Scale (acute)
The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response.
Clinical Global Impression - Improvement Scale (crossover)
The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response.
Full Information
NCT ID
NCT03601312
First Posted
June 5, 2018
Last Updated
April 7, 2022
Sponsor
University of California, Los Angeles
Collaborators
Virtually Better, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03601312
Brief Title
Randomized Controlled Trial of Standard ERP and OC-Go
Acronym
OC-GoPhaseII
Official Title
OC-Go: Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
August 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Virtually Better, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase II of this study will examine the efficacy of the OC-Go application via a randomized controlled trial comparing standard exposure and response prevention (ERP) treatment for pediatric obsessive compulsive disorder (OCD) to exposure/response prevention (ERP) augmented with OC-Go. A cross-over design will be implemented for these 12 sessions of treatment, in which participants that were randomized to standard ERP will receive OC-Go augmented ERP for the second half of treatment, and vice versa. Efficacy will be investigated in a sample of 32 children with OCD.
Detailed Description
This project seeks to refine and assess OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (EBT) for OCD, a common and impairing condition, and provider ability to effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. Accordingly, patients can be guided to do assignments by themselves between sessions with increased fidelity over the course of treatment. Once therapy assignments are created and shared to a crowd-sourced and curated public library, any clinician can assign any task to any patient for homework or in-session use with one touch. Use of OC-Go is expected to increase patient engagement, compliance, treatment efficiency, dissemination of EBTs, and therapist confidence and expertise.
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
Crossover Assignment
Model Description
All participants will receive 12 weeks of exposure/response/prevention (ERP). Sessions 1 (psychoeducation/hierarchy creation) and 12 (relapse prevention & generalization training) will be identical across both randomization groups.
Treatment sequences for the randomization groups will be as follows:
OC-GO-FIRST - Sessions 2-6: ERP+OC-Go, Sessions 7-11: Standard ERP
STANDARD ERP-FIRST - Sessions 2-6: Standard ERP, Sessions 7-11: ERP+OC-Go
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will not have information about the participant's treatment condition, so they will not know whether or not they are receiving treatment as usual (Standard ERP) or OC-Go augmented ERP.
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment-As-Usual
Arm Type
Active Comparator
Arm Description
Individuals receiving treatment as usual will be receiving exposure and response prevention (ERP), the standard of care for pediatric OCD.
Arm Title
OC-Go
Arm Type
Experimental
Arm Description
Individuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application.
Intervention Type
Behavioral
Intervention Name(s)
Exposure and Response Prevention
Intervention Description
Exposure and response prevention is an evidence-based behavioral treatment that primarily focuses on exposures, in which the child faces OCD-related fears in a methodical manner and acquires more adaptive coping strategies.
Intervention Type
Behavioral
Intervention Name(s)
OC-Go
Intervention Description
OC-Go is a HIPAA-compliant web-based clinician portal and patient-side mobile application that allows clinicians to create and push tailored treatment assignments to patients on their mobile devices. Individuals receiving this intervention will receive exposure and response prevention with OC-Go.
Primary Outcome Measure Information:
Title
Homework compliance
Description
Homework Compliance (%; range 0-100) = (Total homework assignments completed treatment weeks 2-11/Total homework assignments assigned weeks 2-11) * 100
Time Frame
End of Week 14
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Improvement Scale (acute)
Description
The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response.
Time Frame
End of Week 6
Title
Clinical Global Impression - Improvement Scale (crossover)
Description
The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response.
Time Frame
End of Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 9-17 years old
Primary diagnosis of OCD based on diagnostic interview (ADIS)
CGI-Severity score > 3
Exclusion Criteria:
Anti-OCD medication/unstable dose (with changes expected during the study)
Significant and interfering comorbid psychiatric, psychosocial, neurological, or medical condition (e.g., acute suicidality, low IQ, etc.) precluding the child's ability to complete all study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Piacentini, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ. of California / Los Angeles / Semel Inst.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024-1759
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Controlled Trial of Standard ERP and OC-Go
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