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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Obsessive-Compulsive Disorder

Treatments: Behavioral: OC-Go; Behavioral: Exposure and Response Prevention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03601312

R42MH111277-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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27 participants in 2 patient groups

Treatment-As-Usual

Active Comparator group

Description:

Individuals receiving treatment as usual will be receiving exposure and response prevention (ERP), the standard of care for pediatric OCD.

Treatment:

Behavioral: Exposure and Response Prevention

OC-Go

Experimental group

Description:

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

Treatment:

Behavioral: OC-Go