Randomized Controlled Trial of Standard ERP and OC-Go

NCT03601312 | Completed

• 1 other identifier: R42MH111277-02
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Homework compliance

  Homework Compliance (%; range 0-100) = (Total homework assignments completed treatment weeks 2-11/Total homework assignments assigned weeks 2-11) \* 100

  End of Week 14

Secondary Outcomes (2)

• Clinical Global Impression - Improvement Scale (acute)

  End of Week 6

• Clinical Global Impression - Improvement Scale (crossover)

  End of Week 14

Study Arms (2)

Treatment-As-Usual

ACTIVE COMPARATOR

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

OC-Go

EXPERIMENTAL

Individuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application.

Behavioral: OC-Go

Interventions

Exposure and Response Prevention BEHAVIORAL

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.

Treatment-As-Usual

OC-Go BEHAVIORAL

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.

OC-Go

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 9-17 years old
• Primary diagnosis of OCD based on diagnostic interview (ADIS)
• CGI-Severity score \> 3

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Virtually Better, Inc.: collaborator

Study Sites (1)

Univ. of California / Los Angeles / Semel Inst.

Los Angeles, California, 90024-1759, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• John Piacentini, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 26, 2018
• Study Start: November 1, 2018
• Primary Completion: June 18, 2021
• Study Completion: August 11, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)