VoIP Delivered Behavior Therapy for Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Voice Over Internet Protocol Delivered Behavior Therapy for Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247206
• Other study ID #: MIL105611
• Secondary ID: F31MH096375-015F
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2014
• Last updated: September 18, 2014
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: September 2014
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• Resides in the state of Wisconsin

• Ages 8-17

• Meets DSM-IV-TR diagnostic criteria for Chronic Tic Disorder (CMVT or TS)

• Clinical global Impressions - Severity Score greater than or equal to 4 (moderately ill)

• YGTSS Total Score greater than or equal to 14 and less than 30 OR Total Score greater than or equal to 10 and less than 20 if CTD with motor tics only

• Unmedicated or on stable medication treatment for tics, OCD, ADHD, anxiety, and/or depressive disorder for at least 6 weeks, with no planned changes for duration of study participation

• Fluent English speaker

Exclusion Criteria:

• YGTSS Total Tic Score > 30 (for any score exceeding 30 on the YGTSS, the research team determined the appropriateness of the patient's participation in the study, taking into account the patient's global functioning)

• WASI-Vocab subtest T-Score < 37

• DSM-IV substance abuse or dependence or Conduct Disorder within the past 3 months

• Lifetime DSM-IV diagnosis of Pervasive developmental disorder, Mania, or Psychotic Disorder

• Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current

• Previous treatment with HRT for tics (four or more sessions)

• Lack of a functional, and accessible home computer, and high speed (i.e., cable/DSL) internet connection

• Refusal to sign a release of information form for the child's local primary care physician, mental health professional, or neurologist.

Study Design

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

Related Conditions & MeSH terms

• Chronic Tic Disorder
• Syndrome
• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Behavioral:
• Behavior Therapy for Tics (CBIT)
CBIT is an 8-session 10-week behavioral treatment for chronic tic disorders, including Tourette Syndrome. The first two sessions are 90 minutes, with subsequent sessions lasting 60 minutes. The treatment consists of Habit Reversal Training (awareness training, competing response training, and social support), and function-based assessment to reduce the impact of environmental or other stimuli on tic severity. The treatment also consists of relaxation techniques to reduce tic-related stress and tension, and behavioral rewards to motivate treatment compliance.

Locations

Country	Name	City	State
United States	University of Wisconsin-Milwaukee Psychology Department	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee	National Institute of Mental Health (NIMH), University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks	The YGTSS is a clinician-rated tic severity measure, featuring a total severity score, with a rating from 0 to 50, and independent subtotals for motor and vocal tics each with ratings from 0 to 25. It also features a tic-related 0-50 point impairment scale.	Baseline, 10-week (post-treatment)	No
Secondary	Change from baseline on the Clinical Global Impressions-Severity scale at 10 weeks	The CGI-S is a clinician-rated measure of patient global impairment.	Baseline, 10-week (post-treatment)	No
Secondary	Treatment response rate using the Clinical Global Impressions-Improvement scale at 10 weeks	The CGI-I is a rating of patient improvement compared to baseline. Scores of Much (2) or Very Much (1) Improved indicate positive treatment response in this study.	10-week (post-treatment)	No