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

NCT05166707 | Unknown DMC FDA Device

• 1 other identifier: BX-DT-FP-OCF-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale (Y-BOCs)

  The Y-BOCS is the gold-standard, semi-structured clinician-administered assessment of OCD severity. It contains 10 items ranging from 0 to 4, which are summed to generate a total score (range = 0-40). Higher scores indicate more severe OCD symptoms. The Y-BOCS will be used to assess change in OCD symptoms from baseline to endpoint.

  Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)

Secondary Outcomes (4)

• Clinical Global Impression - Improvement scale (CGI-I)

  Endpoint (week 6), Follow-up (week 10)

• Clinical Global Impression-Severity Scale (CGI-S)

  Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)

• Beck Depression Inventory II

  Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)

• Beck Anxiety Inventory

  Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)

Study Arms (1)

BIXINK OC Free

EXPERIMENTAL

A 6 week ERP-based intervention

Device: BIXINK OC Free

Interventions

BIXINK OC Free DEVICE

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.

BIXINK OC Free

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• BIXINK Therapeutics Co., Ltd.: lead

Study Sites (1)

Spectrum Neuroscience and Treatment Institute

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Eric Hollander, MD

  Spectrum Neuroscience and Treatment Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nick Lee, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 22, 2021
• Study Start: October 18, 2021
• Primary Completion: November 18, 2022
• Study Completion: May 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)