Feasibility, Acceptability, and Preliminary Efficacy of a Mobile App (nOCD) for OCD

Obsessive Compulsive Disorder (OCD) Clinical Trial

— nOCD  

Official title:

Feasibility, Acceptability, and Preliminary Efficacy of a Mobile App (nOCD) for OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476902
• Other study ID #: 7572
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2020
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, acceptability, and potential usefulness of using a mobile application (nOCD) for treatment of obsessive compulsive disorder (OCD) in a sample of 25 adults (ages 18-65) in an 8 week trial. nOCD is a free iOS/Android application that provides treatment strategies. The study team will evaluate the effect of the application using gold-standard clinician-administered and self-report measures. Prior to downloading the application, participants will receive 4 (up to 5) in-person visit (orientation to the app and psychoeducation) and receive brief weekly phone check-ins. The long-term goal of this study is to use this information to develop new treatments for patients with OCD. All study procedures will be conducted on site at the New York State Psychiatric Institute.

Description:

The purpose of this study is to evaluate the feasibility, acceptability, and potential usefulness of using a mobile app (nOCD) for treatment of OCD in a sample of 25 adults (ages 18-65). nOCD is a free iOS/Android app that provides EX/RP-consistent treatment strategies. The study team will evaluate the effect of the app using gold-standard clinician-administered and self-report measures. Prior to downloading the app, participants will receive 4 (up to 5) in-person visits and receive brief weekly phone check-in. The long term goal of this line of research is to increase access to evidence-based treatment and to ultimately reach more patients giving them access to tools to reduce their OCD symptoms and improve their quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Primary DSM-5 diagnosis of obsessive-compulsive disorder

• Age 18-65

• Not currently receiving psychotherapy focused on OCD symptoms, and no EX/RP within the past 12 weeks

• For those currently on medication: On a stable dose of psychiatric medication (for at least 12 weeks)

• Capacity to provide informed consent

Exclusion Criteria:

• Comorbid psychiatric conditions that significantly elevate the risk of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality).

Related Conditions & MeSH terms

• Obsessive Compulsive Disorder (OCD)
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Therapist assisted mobile intervention
Individuals will receive 4 introductory sessions with a therapist followed by weekly phone calls. Participants will utilize nOCD application to assist with treatment protocol adherence.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of using a therapist assisted mobile app using the System Usability Scale (SUS).	Feasibility and acceptability will be assessed using the System Usability Scale (SUS) at post treatment. SUS scores range from 0-100 with higher scores indicating better outcomes.	8 weeks
Primary	Effect of therapist assisted mobile app on OCD symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).	Reduction in OCD symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Y-BOCS scores range from 0-40 with lower values representing better outcomes.	Baseline and approximately 8 weeks

External Links

•   Center for OCD & Related Disorders Webpage