PSYC Tech, Ltd. — Department of Health and Human Services SBIR Phase II: 104

Description

Abstract (Project 2R44MH111450-03A1) Tic disorders (TDs) are a class of neurodevelopmental disorders characterized by involuntary motor and vocal tics1 that affect 1%-3% of the population2 and cause substantial distress, interference and disability.3-9 Comprehensive Behavioral Intervention for Tics (CBIT) is an empirically-validated collection of behavioral tic management techniques that is now internationally recommended as a first-line intervention for patients with TD 10,15,16. Although CBIT is effective and highly desired by patients,8,17-19 it is not widely available due to a lack of trained providers.8,17-19 Within the current Phase II SBIR project, we successfully employed a stakeholder- informed CTAP implementation framework21 and iterative development process to create an interactive online program for training therapists to administer CBIT (CBIT-Trainer) and pilot tested the program with a sample of CBIT-Naïve therapists. Results from the pilot test surpassed our a priori criteria for initiation of the final stage of the project, which is to conduct a large-scale test of CBIT-Trainer, examining both therapist and patient outcomes, using an effectiveness- implementation hybrid approach23 to conduct a randomized controlled noninferiority trial comparing CBIT-Trainer to the gold-standard in-person BTI training (BTI). The primary and secondary aims of the clinical trial are to (1) compare CBIT-Trainer to the in-person BTI on therapists’ ability to administer the core components of CBIT; (2) to compare patient response to CBIT when treated by a therapist trained via the in-person BTI or CBIT-Trainer; and (3) to identify therapist-level facilitators/barriers to adopting CBIT-Trainer and to implementing and sustaining CBIT as a first-line intervention for TD patients after training.