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Randomized Controlled Trial of Standard ERP and OC-Go (OC-GoPhaseII)

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ClinicalTrials.gov Identifier: NCT03601312
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Virtually Better, Inc.
Information provided by (Responsible Party):
John Piacentini, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Exposure and Response Prevention Behavioral: OC-Go Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
Official Title: OC-Go: Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment-As-Usual
Individuals receiving treatment as usual will be receiving exposure and response prevention (ERP), the standard of care for pediatric OCD.
Behavioral: Exposure and Response Prevention
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.

Experimental: OC-Go
Individuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application.
Behavioral: OC-Go
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 Measures :
  1. Homework compliance [ Time Frame: End of Week 14 ]
    Homework Compliance (%; range 0-100) = (Total homework assignments completed treatment weeks 2-11/Total homework assignments assigned weeks 2-11) * 100


Secondary Outcome Measures :
  1. Clinical Global Impression - Improvement Scale (acute) [ Time Frame: End of Week 6 ]
    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.

  2. Clinical Global Impression - Improvement Scale (crossover) [ Time Frame: End of Week 14 ]
    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.



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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601312


Contacts
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Contact: John C Piacentini, Ph.D. 310-825-0122 jpiacentini@mednet.ucla.edu
Contact: Silvia Orellana, B.A. 310-825-0122 sorellana@mednet.ucla.edu

Locations
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United States, California
Univ. of California / Los Angeles / Semel Inst. Not yet recruiting
Los Angeles, California, United States, 90024-1759
Contact: John C Piacentini, PhD    310-825-0122    jpiacentini@mednet.ucla.edu   
Contact: Caitlin Choy, B.A.    310-825-0122    cchoy@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Virtually Better, Inc.
Investigators
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Principal Investigator: John Piacentini, Ph.D. University of California, Los Angeles

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Responsible Party: John Piacentini, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03601312     History of Changes
Other Study ID Numbers: R42MH111277-02 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders