Clinical trial NCT02247206: VoIP Delivered Behavior Therapy for Tourette Syndrome
Official title: Voice Over Internet Protocol Delivered Behavior Therapy for Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tourette Syndrome
Chronic Tic Disorder
Keywords: Tourette Syndrome
tic disorders
behavior therapy
web-based videoconferencing
VoIP
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Utah
First posted: 2014-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks
timeFrame: Baseline, 10-week (post-treatment)
Secondary outcomes:
measure: Change from baseline on the Clinical Global Impressions-Severity scale at 10 weeks
timeFrame: Baseline, 10-week (post-treatment)
measure: Treatment response rate using the Clinical Global Impressions-Improvement scale at 10 weeks
timeFrame: 10-week (post-treatment)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: University of Wisconsin-Milwaukee Psychology Department
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Emily J Ricketts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas A&M University
name: Douglas W Woods, PhD
role: STUDY_DIRECTOR
affiliation: University of Utah
name: Michael B Himle, PhD
role: STUDY_CHAIR
References: