VoIP Delivered Behavior Therapy for Tourette Syndrome

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Brief Title

VoIP Delivered Behavior Therapy for Tourette Syndrome

Official Title

Voice Over Internet Protocol Delivered Behavior Therapy for Tourette Syndrome

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks

Secondary Outcome

 Change from baseline on the Clinical Global Impressions-Severity scale at 10 weeks

Condition

Tourette Syndrome

Intervention

Behavior Therapy for Tics (CBIT)

Study Arms / Comparison Groups

 Behavior Therapy for Tics (CBIT)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Behavioral

Estimated Enrollment

20

Start Date

December 2012

Completion Date

November 2013

Primary Completion Date

September 2013

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.

Gender

All

Ages

8 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Emily J Ricketts, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02247206

Organization ID

MIL105611

Secondary IDs

F31MH096375-01

Responsible Party

Principal Investigator

Study Sponsor

University of Wisconsin, Milwaukee

Collaborators

 National Institute of Mental Health (NIMH)

Study Sponsor

Emily J Ricketts, PhD, Principal Investigator, University of Wisconsin, Milwaukee

Verification Date

September 2014