Obsessive-Compulsive Disorder
Conditions
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.
Interventions
BEHAVIORALExposure 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.
BEHAVIORALOC-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.
Sponsors
Virtually Better, Inc.
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
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.
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
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed