Clinical trial NCT03601312: Randomized Controlled Trial of Standard ERP and OC-Go
Official title: OC-Go: Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Virtually Better, Inc.
First posted: 2018-07-26
Enrollment: 27
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Homework compliance
timeFrame: End of Week 14
Secondary outcomes:
measure: Clinical Global Impression - Improvement Scale (acute)
timeFrame: End of Week 6
measure: Clinical Global Impression - Improvement Scale (crossover)
timeFrame: End of Week 14
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Univ. of California / Los Angeles / Semel Inst.
state: California
Study officials:
affiliation: University of California, Los Angeles
name: John Piacentini, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: