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

Primary Purpose

Obsessive Compulsive Disorder (OCD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapist assisted mobile intervention
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder (OCD) focused on measuring OCD, Mobile, Technology, CBT, Cognitive-Behavioral Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Integrated Mobile Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2018
Last Updated
March 17, 2020
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03476902
Brief Title
Feasibility, Acceptability, and Preliminary Efficacy of a Mobile App (nOCD) for OCD
Acronym
nOCD
Official Title
Feasibility, Acceptability, and Preliminary Efficacy of a Mobile App (nOCD) for OCD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder (OCD)
Keywords
OCD, Mobile, Technology, CBT, Cognitive-Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Mobile Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapist assisted mobile intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and acceptability of using a therapist assisted mobile app using the System Usability Scale (SUS).
Description
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.
Time Frame
8 weeks
Title
Effect of therapist assisted mobile app on OCD symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
Description
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.
Time Frame
Baseline and approximately 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Gershkovich, Ph.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33622508
Citation
Gershkovich M, Middleton R, Hezel DM, Grimaldi S, Renna M, Basaraba C, Patel S, Simpson HB. Integrating Exposure and Response Prevention With a Mobile App to Treat Obsessive-Compulsive Disorder: Feasibility, Acceptability, and Preliminary Effects. Behav Ther. 2021 Mar;52(2):394-405. doi: 10.1016/j.beth.2020.05.001. Epub 2020 May 11.
Results Reference
derived
Links:
URL
http://columbiapsychiatry.org/ocd
Description
Center for OCD & Related Disorders Webpage

Learn more about this trial

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

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