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

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ClinicalTrials.gov Identifier: NCT03476902
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Helen Blair Simpson, New York State Psychiatric Institute

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : October 27, 2017
Estimated Primary Completion Date : October 27, 2019
Estimated Study Completion Date : December 27, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476902


Contacts
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Contact: Rachel Middleton, B.A. 646-774-8138 Rachel.Middleton@nyspi.columbia.edu
Contact: Marina Gershkovich, Ph.D. Marina.Gershkovich@nyspi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Rachel Middleton, B.A.    646-774-8138    Rachel.Middleton@nyspi.columbia.edu   
Principal Investigator: Marina Gershkovich, Ph.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Marina Gershkovich, Ph.D. New York State Psychiatric Institute

Additional Information:
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Responsible Party: Helen Blair Simpson, Research Chief, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03476902     History of Changes
Other Study ID Numbers: 7572
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helen Blair Simpson, New York State Psychiatric Institute:
OCD
Mobile
Technology
CBT
Cognitive-Behavioral Therapy
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders