Randomized Controlled Trial of Standard ERP and OC-Go
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Behavioral: OC-GoBehavioral: Exposure and Response Prevention
- Registration Number
- NCT03601312
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- Ages 9-17 years old
- Primary diagnosis of OCD based on diagnostic interview (ADIS)
- CGI-Severity score > 3
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description OC-Go OC-Go Individuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application. Treatment-As-Usual Exposure and Response Prevention Individuals receiving treatment as usual will be receiving exposure and response prevention (ERP), the standard of care for pediatric OCD.
- Primary Outcome Measures
Name Time Method Homework compliance 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
Name Time Method Clinical Global Impression - Improvement Scale (acute) 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.
Clinical Global Impression - Improvement Scale (crossover) 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.
Trial Locations
- Locations (1)
Univ. of California / Los Angeles / Semel Inst.
🇺🇸Los Angeles, California, United States