VoIP Delivered Behavior Therapy for Tourette Syndrome

NCT02247206 | Completed Phase 2

• 3 other identifiers: MIL105611F31MH096375-015F31MH096375-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome; Chronic Tic Disorder

Keywords

Tourette Syndrome; tic disorders; behavior therapy; web-based videoconferencing; VoIP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Baseline, 10-week (post-treatment)

• Treatment response rate using the Clinical Global Impressions-Improvement scale at 10 weeks

  10-week (post-treatment)

Study Arms (2)

Behavior Therapy for Tics (CBIT)

EXPERIMENTAL

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)

Waitlist-control Group

NO INTERVENTION

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.

Interventions

Behavior Therapy for Tics (CBIT) BEHAVIORAL

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.

Also known as: Comprehensive Behavioral Intervention for Tics (CBIT), Habit Reversal Training (HRT)

Behavior Therapy for Tics (CBIT)

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Utah: collaborator

Study Sites (1)

University of Wisconsin-Milwaukee Psychology Department

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Emily J Ricketts, PhD

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

• Douglas W Woods, PhD

  Texas A&M University

  STUDY DIRECTOR

• Michael B Himle, PhD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 23, 2014
• Study Start: December 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 23, 2014

Record last verified: 2014-09

Locations

US (1)