Recruiting

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

Sponsor:

BIXINK Therapeutics Co., Ltd.

Code:

NCT05166707

Conditions

Obsessive-compulsive Disorders and Symptoms

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BIXINK OC Free

Study Details

Brief summary:

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.'

Conditions

Obsessive-compulsive Disorders and Symptoms

Obsessive-Compulsive Disorder

Study ID

NCT05166707

Start date

Oct 18, 2021

Status verified date

Feb, 2023

Completion date

May, 2023

Anticipated

Primary completion date

Nov 18, 2022

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BIXINK OC Free

A 6 week ERP-based intervention

Interventions

BIXINK OC Free

OC Free is a 6-week ERP-based intervention to deliver Exposure and Response Prevention (ERP) to reduce the anxiety from obsessive thoughts and compulsive rituals.

Primary outcome measure

Yale-Brown Obsessive-Compulsive Scale (Y-BOCs) [ Time Frame: Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10) ]

Central Contacts and Locations

Central contacts

Nick Lee, MS

+82-70-5223-2869 cl.lee@bixink.com

Locations

Spectrum Neuroscience and Treatment Institute

Recruiting

New York, New York, United States, 10021

Contacts

Emily Sachs, BA

646-351-0220 emilysachs@spectrumneuroscience.org

Principal Investigator:

Eric Hollander, MD

More Information

Sponsor

BIXINK Therapeutics Co., Ltd.

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BIXINK Therapeutics Co., Ltd. on 2023-02-08.