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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05166707
Other study ID # BX-DT-FP-OCF-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 18, 2021
Est. completion date May 2023

Study information

Verified date February 2023
Source BIXINK Therapeutics Co., Ltd.
Contact Nick Lee, MS
Phone +82-70-5223-2869
Email cl.lee@bixink.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.'


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
United States Spectrum Neuroscience and Treatment Institute New York New York

Sponsors (1)

Lead Sponsor Collaborator
BIXINK Therapeutics Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Clinical Global Impression - Improvement scale (CGI-I) The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response. Endpoint (week 6), Follow-up (week 10)
Secondary Clinical Global Impression-Severity Scale (CGI-S) The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. Scores range from 1 (Normal - not at all ill, symptoms of disorder not present past seven days) to 7 (extremely ill - pathology drastically interferes in many life functions; may be hospitalized). Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)
Secondary Beck Depression Inventory II The BDI is a 21 item self-reporting measure of depression, rated on a 0-3 scale, with responses being specific to the questions. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression. Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)
Secondary Beck Anxiety Inventory The BAI is a 21 item self-reporting measure of anxiety, rated on a 0-3 scale, with 0 being not at all to 3 being severely-it bothered me a lot. A total score of 0-7 is interpreted as a "Minimal" level of anxiety; 8-15 as "Mild"; 16-25 as "Moderate", and; 26-63 as "Severe". Screening/Baseline (week 0), Endpoint (week 6), Follow-up (week 10)
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