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

March 17, 2020 updated by: Helen Blair Simpson, New York State Psychiatric Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: Marina Gershkovich, Ph.D., New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2017

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7572

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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