NCT03476902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

March 12, 2018

Last Update Submit

March 17, 2020

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

OCDMobileTechnologyCBTCognitive-Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 weeks

  • 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.

    Baseline and approximately 8 weeks

Study Arms (1)

Integrated Mobile Treatment

EXPERIMENTAL

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

Interventions

Therapist assisted mobile interventionBEHAVIORAL

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.

Integrated Mobile Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 33622508DERIVED

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Marina Gershkovich, Ph.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Chief

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 26, 2018

Study Start

October 27, 2017

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)