VoIP Delivered Behavior Therapy for Tourette Syndrome

Voice Over Internet Protocol Delivered Behavior Therapy for Tourette Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Tourette Syndrome; Chronic Tic Disorder
• Intervention / Treatment: Behavioral: Behavior Therapy for Tics (CBIT)

Detailed 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53211
      • University of Wisconsin-Milwaukee Psychology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavior Therapy for Tics (CBIT); The child 1) learns to become more aware of any sensations, or urges that may trigger tics, and 2) learn some other behavior (competing response) to do every time he/she feels the urge to tic. The child's parent is trained to provide prompts and praise for use of the competing response. The parent and family also receive psychoeducation about tics, and learn ways to reduce the impact of environmental stimuli on tic severity. The child learns relaxation techniques to reduce stress and make it easier for him/her to resist his or her tics. Prior to treatment sessions, the parent and child spend about 10 minutes discussing with the therapist any problematic issues he/she is having. At the end of treatment sessions the child is assigned some tasks to practice prior to the next session.	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.; Other Names: Comprehensive Behavioral Intervention for Tics (CBIT); Habit Reversal Training (HRT)
No Intervention: Waitlist-control Group; Participants in the waitlist-control group, do not receive behavior therapy for tics or any other treatment during the 10-week acute treatment period. Instead they child are placed on a waitlist to receive videoconference-delivered treatment following the end of the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Milwaukee
• Collaborators: National Institute of Mental Health (NIMH); University of Utah
• Investigators: Principal Investigator: Emily J Ricketts, PhD, University of Wisconsin, Milwaukee; Study Director: Douglas W Woods, PhD, Texas A&M University; Study Chair: Michael B Himle, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: September 15, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 23, 2014

Study Record Updates

• Last Update Posted (Estimate): September 23, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: behavior therapy; Tourette Syndrome; tic disorders; web-based videoconferencing; VoIP
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Syndrome; Tourette Syndrome; Tic Disorders; Tics
• Other Study ID Numbers: MIL105611; F31MH096375-01 (U.S. NIH Grant/Contract); 5F31MH096375-02 (U.S. NIH Grant/Contract)