Evaluation of the Efficacy and Safety of an Accelerated Protocol for Obsessive and Compulsive Behaviour Using the BTL-699-2 Device
BTL Industries Ltd.
Summary
The goal of this investigational study is to evaluate if the treatment using EXOMIND(BTL-699-2) device is able to improve severity of obsessive and compulsive symptoms in adults (aged 22 and older). The main question it aims to answer is: Does the treatment using EXOMIND (BTL-699-2) device is able safely and efficiently reduce the severity of obsessive and compulsive behaviors? Participants will be asked to: * Complete six treatment visits (twelve treatment sessions) * Complete The Yale-Brown Obsessive-Compulsive Severity Scale Second Edition Self Report Version (Y-BOCS-II SR) * Complete Short UPPS-P Impulsive Behaviour Scale (SUPPS-P) * Compete The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) * Compete The Patient Health Questionnaire-9 (PHQ-9) * Compete Columbia Suicide Severity Rating Scale -screen version(CSSRS) * Complete Trigger Recall Experience Questionnaire (only for participants who agree to participate in trigger recall procedure during the treatment sessions) * Compete The Therapy Comfort Questionnaire * Compete The Subject Satisfaction Questionnaire
Description
This is a prospective, interventional, multi-centre, single-blinded, two-arm study. The subjects will be enrolled and randomly assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with the BTL-699-2 device. Group A will receive active treatment (BTL-699-2 with intensity up to 80% of the individual's motor threshold (MT), and Group B will receive sham treatment (BTL-699-2 with intensity of 5% of the individual's MT). The Yale-Brown Obsessive-Compulsive Severity Scal…