VoIP Delivered Behavior Therapy for Tourette Syndrome

Status Completed

Clinical Trial Summary

The purpose of this research is to examine the preliminary efficacy, feasibility, and acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette Syndrome through in a randomized waitlist-controlled trial.

Clinical Trial Description

A Comprehensive Behavioral Intervention for Tics (CBIT) is an emerging treatment for children with Tourette Syndrome (TS) and has been shown to be efficacious in separate randomized trials with children and adults; however, many families of children with TS are prevented from accessing it due to limited availability of adequately trained treatment providers. Recent research has shown that videoconference-delivered CBIT is as effective as face to face delivery, and that both modalities are efficacious. Despite its effectiveness, traditional videoconferencing has limitations including lack of portability, ease of access, the need for third party clinics, and cost. A newer, more convenient alternative to increase access is the use of Voice over Internet Protocol (VoIP) transmission, allowing for the direct delivery of CBIT to patients' homes.

Therefore the objective of this study (the final phase of a three-phase project) is to establish the preliminary efficacy of VoIP-modified CBIT for reducing tics in children with TS relative to a waitlist-control. Twenty children (ages 9-17) with TS or Chronic Tic Disorder as a primary diagnosis will be recruited for a randomized, observer-blind, waitlist controlled trial of VoIP-delivered CBIT. Participants will be randomly assigned to 8 weekly sessions of CBIT-VoIP over a 10-week acute treatment period, or waitlist control condition. As an exploratory aim, the current study will investigate potential correlates of treatment outcome, including home computer equipment available (i.e., web camera type, microphone type, internet upload speed, and type of internet connection), prior computer experience, and comfort with study computer equipment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02247206
Study type	Interventional
Source	University of Wisconsin, Milwaukee
Contact
Status	Completed
Phase	Phase 2
Start date	December 2012
Completion date	November 2013

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.