RECRUITING

An ERP-based Mobile Intervention as an Adjunctive Treatment for OCD

Conditions

Obsessive-compulsive Disorders and Symptoms Obsessive-Compulsive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this feasibility study is to evaluate the feasibility, acceptability, and potential usefulness of the investigational device, a mobile software application (app) (OC Free) for treatment of OCD (contamination obsession only), adjunctive to individuals receiving outpatient ERP therapy. OC Free is an iOS/Android app that provides treatment via computerized exposure and response prevention (ERP). The study will evaluate preliminary safety and effectiveness of the app using gold-standard, validated 'clinician-administered' and 'self-reporting measures.'

Official Title

A Prospective, Single Arm, Open, Single-center, Feasibility Study to Assess the Effectiveness and Safety of Mobile App (OC Free) for Patients With Obsessive-Compulsive Disorder (OCD)

Quick Facts

Study Start:2021-10-18

Study Completion:2023-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05166707

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ages 18 years and older * Primary DSM-5 diagnosis of obsessive-compulsive disorder * Mild to Moderate OCD severity (8 ≤ Y-BOCS ≤ 23) * Subjects must currently be engaged (initiated and ongoing) in formal psychotherapy, ERP, prior to enrollment * Subjects currently on medication that wish to participate in the study: Taking a confirmed adequate and stable dose of a Serotonin Reuptake Inhibitor (SRI) or Selective Serotonin Reuptake Inhibitor (SSRI), as determined by the Investigator, for at least 6 consecutive weeks prior to screening * Confirmed contamination fears, as defined by a score of at least 10 points on the Padua Inventory Contamination Fear Subscale 30 (PI CF) during the initial telephone screening and at least 9 on the PI CF during the first laboratory testing session * CGI-Severity score ≥ 2 * Currently living in the United States * Ability to read, write, and comprehend English * Patient willing to provide informed consent	* Subjects who are study site staff members or subjects who are employees directly involved in the conduct of the study * Subjects with a history of at least two (2) treatment failures with a Serotonin Reuptake Inhibitor (SRI) and/or Selective Serotonin Reuptake Inhibitor (SSRI) at a confirmed adequate dose and for an adequate duration, as determined by the investigator * Severe and extreme OCD severity (Y-BOCS ≥ 24) * Current or previous symptoms of psychosis, including delusions, or history consistent with a psychotic disorder, in the opinion of the investigator * Current or previous compulsions that may place the subject or others at risk, in the opinion of the Investigator * History of a violent tendencies, action(s) or thoughts or predilection towards violence in the opinion of the Investigator * Any comorbid diseases or disorders (as determined by clinical judgement and supported by the MINI v.6 diagnostic instrument) that significantly elevates the risk of study participation or obscure the evaluation of effectiveness (e.g., psychotic disorders, Major Depressive Disorder, Bipolar Disorder, evidence of dementia or other Cognitive Disorder) * Baseline C-SSRS: answer of yes to items 3, 4 or 5 within previous 12-month period) and/or BDI-II Exclusion (item 9, score of 2 or 3) * History of one or more suicide attempts (in the last 12 months) or subjects who, in the opinion of the investigator, present a serious risk of suicide, determined also by C-SSRS * Subjects presenting a risk for self-harm or self-injurious behavior(s) or a risk of harming others (in the last 12 months) as judged by the investigator in consultation with the medical monitor * Current severe substance use disorder as determined by the M.I.N.I diagnostic instrument excluding caffeine * Vision or hearing impairment that, in the opinion of the Investigator, might reduce, limit or adversely affect the subject's ability to comply with the requirements of the study or might affect the integrity of the data * Does not own a supported mobile smartphone with a data plan * Any physical, medical (including psychiatric) or other condition that, in the opinion of the investigator, might reduce, limit or adversely affect the subject's ability to comply with the requirements of the study or might affect the integrity of the data * Use of a smartphone app in past for treatment of any psychiatric disorder, including OCD, depression or anxiety disorder * A history of addiction to, dependence on, abuse of, misuse of, distribution of or use of any substance, including alcohol and nicotine, within the past one year

Inclusion Criteria

Exclusion Criteria

* Ages 18 years and older
* Primary DSM-5 diagnosis of obsessive-compulsive disorder
* Mild to Moderate OCD severity (8 ≤ Y-BOCS ≤ 23)
* Subjects must currently be engaged (initiated and ongoing) in formal psychotherapy, ERP, prior to enrollment
* Subjects currently on medication that wish to participate in the study: Taking a confirmed adequate and stable dose of a Serotonin Reuptake Inhibitor (SRI) or Selective Serotonin Reuptake Inhibitor (SSRI), as determined by the Investigator, for at least 6 consecutive weeks prior to screening
* Confirmed contamination fears, as defined by a score of at least 10 points on the Padua Inventory Contamination Fear Subscale 30 (PI CF) during the initial telephone screening and at least 9 on the PI CF during the first laboratory testing session
* CGI-Severity score ≥ 2
* Currently living in the United States
* Ability to read, write, and comprehend English
* Patient willing to provide informed consent

* Subjects who are study site staff members or subjects who are employees directly involved in the conduct of the study
* Subjects with a history of at least two (2) treatment failures with a Serotonin Reuptake Inhibitor (SRI) and/or Selective Serotonin Reuptake Inhibitor (SSRI) at a confirmed adequate dose and for an adequate duration, as determined by the investigator
* Severe and extreme OCD severity (Y-BOCS ≥ 24)
* Current or previous symptoms of psychosis, including delusions, or history consistent with a psychotic disorder, in the opinion of the investigator
* Current or previous compulsions that may place the subject or others at risk, in the opinion of the Investigator
* History of a violent tendencies, action(s) or thoughts or predilection towards violence in the opinion of the Investigator
* Any comorbid diseases or disorders (as determined by clinical judgement and supported by the MINI v.6 diagnostic instrument) that significantly elevates the risk of study participation or obscure the evaluation of effectiveness (e.g., psychotic disorders, Major Depressive Disorder, Bipolar Disorder, evidence of dementia or other Cognitive Disorder)
* Baseline C-SSRS: answer of yes to items 3, 4 or 5 within previous 12-month period) and/or BDI-II Exclusion (item 9, score of 2 or 3)
* History of one or more suicide attempts (in the last 12 months) or subjects who, in the opinion of the investigator, present a serious risk of suicide, determined also by C-SSRS
* Subjects presenting a risk for self-harm or self-injurious behavior(s) or a risk of harming others (in the last 12 months) as judged by the investigator in consultation with the medical monitor
* Current severe substance use disorder as determined by the M.I.N.I diagnostic instrument excluding caffeine
* Vision or hearing impairment that, in the opinion of the Investigator, might reduce, limit or adversely affect the subject's ability to comply with the requirements of the study or might affect the integrity of the data
* Does not own a supported mobile smartphone with a data plan
* Any physical, medical (including psychiatric) or other condition that, in the opinion of the investigator, might reduce, limit or adversely affect the subject's ability to comply with the requirements of the study or might affect the integrity of the data
* Use of a smartphone app in past for treatment of any psychiatric disorder, including OCD, depression or anxiety disorder
* A history of addiction to, dependence on, abuse of, misuse of, distribution of or use of any substance, including alcohol and nicotine, within the past one year

Contacts and Locations

Study Contact

Nick Lee, MS

CONTACT

+82-70-5223-2869

cl.lee@bixink.com

Principal Investigator

Eric Hollander, MD

PRINCIPAL_INVESTIGATOR

Spectrum Neuroscience and Treatment Institute

Study Locations (Sites)

Spectrum Neuroscience and Treatment Institute

New York, New York, 10021

United States

Collaborators and Investigators

Sponsor: BIXINK Therapeutics Co., Ltd.

Eric Hollander, MD, PRINCIPAL_INVESTIGATOR, Spectrum Neuroscience and Treatment Institute

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 Registration Dates

Study Start Date2021-10-18

Study Completion Date2023-05

Study Record Updates

Study Start Date2021-10-18

Study Completion Date2023-05

Terms related to this study

Additional Relevant MeSH Terms

Obsessive-compulsive Disorders and Symptoms
Obsessive-Compulsive Disorder