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

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03476902

Collaborator

(none)

Enrollment

Location

Arm

23.1

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder (OCD)	Behavioral: Therapist assisted mobile intervention	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 27, 2017

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Integrated Mobile Treatment 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.	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.

Arm

Intervention/Treatment

Experimental: Integrated Mobile Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility and acceptability of using a therapist assisted mobile app using the System Usability Scale (SUS). [8 weeks]
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.
Effect of therapist assisted mobile app on OCD symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). [Baseline and approximately 8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).