Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder

Phase 2

Completed

• Conditions: Tourette Syndrome; Tic Disorders
• Interventions: Behavioral: Supportive therapy; Behavioral: Habit reversal therapy

• Registration Number: NCT00231985
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study will compare the efficacy of supportive therapy versus habit-reversal therapy for the treatment of Tourette syndrome and chronic tic disorder.

Detailed Description

Tourette syndrome and chronic tic disorder are neurological disorders characterized by tics. Tics are involuntary, rapid motor movements or vocalizations that occur suddenly and repeatedly. In adults, the symptoms of Tourette syndrome or chronic tic disorder can be severe. These symptoms often cause difficulties in interpersonal relationships and high unemployment rates. Medication treatments are available for both Tourette syndrome and chronic tic disorder, but most are not completely effective and cause considerable negative side effects. Therefore, non-medication treatments are needed. This study will compare the efficacy of supportive therapy versus habit-reversal therapy for the treatment of Tourette syndrome and chronic tic disorder.

Participants in this open-label study will be randomly assigned to receive either supportive therapy or habit-reversal therapy. Over the course of 10 weeks, all participants will receive 8 treatment sessions of their assigned therapy. The supportive therapy will focus on educating participants on what tics are, how tics present themselves, the causes of tics, the common conditions that may occur along with tics, and environmental factors that may affect their tics (e.g. family, social, school, stress). Habit-reversal therapy will consist of awareness training, relaxation training, self-monitoring, and competing response training. Tic severity, tic-related impairment, depressive symptoms, anxiety symptoms, and obsessive-compulsive symptoms will be assessed at each study session, using diagnostic interviews and self-report scales.

Study Timeline

• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study Start: 2005-10
• Study First Posted: 2005-10-04
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Meets DSM-IV diagnostic criteria for Tourette syndrome or chronic tic disorder
• The primary reason for seeking treatment is Tourette syndrome and/or chronic tic disorder
• Either Tourette syndrome or chronic tic disorder is of more concern than any other simultaneous disease or disorder
• Score greater than 3 on the Clinical Global Impressions Severity Scale
• Score greater than 14 on the Yale Global Tic Severity Scale
• Unmedicated or on stable medication treatment for tics, obsessive compulsive disorder, attention deficit hyperactivity disorder, and/or depressive disorder for at least 6 weeks, and not planning to change medication for the duration of study participation

Exclusion Criteria

• Total tic score greater than 33
• Score less than 80 on the Wechsler Test of Adult Reading
• DSM-IV diagnosis of alcohol or substance dependence within the 3 months prior to study enrollment
• Currently taking psychotropic medications for any psychiatric disorder (except for tics, obsessive compulsive disorder, attention deficit hyperactivity disorder, and/or depressive disorder)
• Any serious psychiatric disorder (e.g., bipolar disorder, psychosis) that requires immediate alternative treatment
• Previously treated with four or more sessions of habit-reversal therapy for tics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Supportive therapy	Participants will receive supportive psychotherapy.
2	Habit reversal therapy	Participants will receive habit reversal therapy.

Primary Outcome Measures

Name	Time	Method
Tic severity	Measured at Week 10

Secondary Outcome Measures

Name	Time	Method
Tic-related impairment	Measured at Week 10
Depressive symptoms	Measured at Week 10
Anxiety symptoms	Measured at Week 10
Obsessive-compulsive symptoms	Measured at Week 10

Trial Locations

Locations (3)

University of Texas Health Sciences Center; 🇺🇸 San Antonio, Texas, United States

OCD Clinic/Psychiatry, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Yale Child Study Center, Yale University; 🇺🇸 New Haven, Connecticut, United States