An ERP-based Mobile Intervention as an Adjunctive Treatment for OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title: A Prospective, Single Arm, Open, Single-center, Feasibility Study to Assess the Effectiveness and Safety of Mobile App (OC Free) for Patients With Obsessive-Compulsive Disorder (OCD)

Status Recruiting

Clinical Trial Summary

The objective of this feasibility study is to evaluate the feasibility, acceptability, and potential usefulness of the investigational device, a mobile software application (app) (OC Free) for treatment of OCD (contamination obsession only), adjunctive to individuals receiving outpatient ERP therapy. OC Free is an iOS/Android app that provides treatment via computerized exposure and response prevention (ERP). The study will evaluate preliminary safety and effectiveness of the app using gold-standard, validated 'clinician-administered' and 'self-reporting measures.'

Clinical Trial Description

Obsessive Compulsive Disorder (OCD) is characterized by the presence of obsessions and/or compulsions that cause clinically significant distress or impairment in multiple areas of functioning. It has a lifetime prevalence of 1-3% and is considered 1 of the 10 most debilitating diseases by the World Health Organization (WHO). One of the most common types of OCD, affecting up to 46% of OCD patients, is characterized by severe contamination fears and excessive washing behaviors. These patients feel anxious even after incidents of minor "contamination" (for example, touching a door knob), and may spend up to several hours painstakingly washing and scrubbing their hands, sometimes causing bleeding and skin damage.

Exposure and Response Prevention (ERP) treatment is often considered as a first-line intervention for contamination OCD in mild to moderate cases. It is a behavioral therapy with the strongest evidence that exposes patients to situations that provoke their obsessive thoughts while helping them cope with their compulsive rituals. Through repetitive "exposure" and "response prevention," patients with contamination OCD can recognize that the dreaded outcome of their obsession is not likely.

Though ERP treatment may be the first-line and most effective psychotherapeutic intervention for contamination OCD, not everyone treated in this intervention show recovery. In fact, many patients fail to complete all of their ERP tasks such as engaging in the homework or ritual prevention techniques outside of the sessions. Therefore, there is an immediate need to encourage patients to engage ERP tasks between the therapy sessions and increase the retention rate of ERP treatment.

To address the unmet needs described above, the proposed intervention is intended to encourage patients to complete their ERP tasks at home and increase retention in outpatient ERP therapy programs. This study aims to evaluate the clinical effectiveness and safety of an ERP - based digital treatment for patients with contamination OCD.

The study will enroll up to 30 male or female subjects aged 18 years and older with a primary diagnosis of OCD based on the criteria. Subjects should have OCD with prominent contamination fears and obsessions as measured on the Padua Inventory Contamination Fear Subscale. Enrolled patients will receive ERP via OC Free for a 6-week treatment period, followed by a 4-week follow-up period to measure preliminary effectiveness and safety.

The obsessive-compulsive symptom improvement (difference between baseline and end of treatment) will be determined by the Yale-Brown Obsessive-Compulsive scale (Y-BOCS). All subjects who have completed treatment with OC Free will be re-evaluated with the Y-BOCS 4 weeks after the end of the treatment (Week 10). ;

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder
• Obsessive-compulsive Disorders and Symptoms

• NCT number: NCT05166707
• Study type: Interventional
• Source: BIXINK Therapeutics Co., Ltd.
• Contact: Nick Lee, MS
• Phone: +82-70-5223-2869
• Email: cl.lee@bixink.com
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2021
• Completion date: May 2023