Randomized Controlled Trial of Standard ERP and OC-Go

University of California, Los Angeles27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obsessive-Compulsive Disorder

Interventions

Exposure and Response PreventionBEHAVIORAL

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.

OC-GoBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Univ. of California / Los Angeles / Semel Inst.

Los Angeles, California, United States

Outcomes

Primary Outcomes

Homework compliance

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 Outcomes

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.

Time frame: End of Week 6

Clinical Global Impression - Improvement Scale (crossover)

Time frame: End of Week 14

Data from ClinicalTrials.gov

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