Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE March 26, 2018
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE October 27, 2017
Estimated Primary Completion Date October 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
  • 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.
  • 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).
Change History Complete list of historical versions of study NCT03476902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility, Acceptability, and Preliminary Efficacy of a Mobile App (nOCD) for OCD
Official Title  ICMJE Feasibility, Acceptability, and Preliminary Efficacy of a Mobile App (nOCD) for OCD
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obsessive Compulsive Disorder (OCD)
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Therapist assisted mobile intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 27, 2019
Estimated Primary Completion Date October 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachel Middleton, B.A. 646-774-8138 Rachel.Middleton@nyspi.columbia.edu
Contact: Marina Gershkovich, Ph.D. Marina.Gershkovich@nyspi.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03476902
Other Study ID Numbers  ICMJE 7572
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Helen Blair Simpson, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marina Gershkovich, Ph.D. New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP