VoIP Delivered Behavior Therapy for Tourette Syndrome

University of Wisconsin, Milwaukee

Status and phase: Completed; Phase 2

Conditions: Chronic Tic Disorder; Tourette Syndrome

Treatments: Behavioral: Behavior Therapy for Tics (CBIT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02247206

F31MH096375-01 (U.S. NIH Grant/Contract)

5F31MH096375-02 (U.S. NIH Grant/Contract)

MIL105611

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Behavior Therapy for Tics (CBIT)

Experimental group

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.

Treatment:

Behavioral: Behavior Therapy for Tics (CBIT)

Waitlist-control Group

No Intervention group

Description:

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.