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

Tourette Syndrome Clinical Trial

Official title:

Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231985
• Other study ID #: R01MH069877
• Secondary ID: R01MH069877DSIR
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2005
• Last updated: February 8, 2012
• Start date: October 2005
• Est. completion date: March 2010

Study information

• Verified date: February 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Behavioral:
• Habit reversal therapy
Habit reversal therapy consists of awareness training, relaxation training, self-monitoring, and competing response training.
• Supportive therapy
Supportive therapy focuses on educating participants about tics: 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).

Locations

Country	Name	City	State
United States	OCD Clinic/Psychiatry, Massachusetts General Hospital	Boston	Massachusetts
United States	Yale Child Study Center, Yale University	New Haven	Connecticut
United States	University of Texas Health Sciences Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bruun RD. Subtle and underrecognized side effects of neuroleptic treatment in children with Tourette's disorder. Am J Psychiatry. 1988 May;145(5):621-4. — View Citation

Lin H, Yeh CB, Peterson BS, Scahill L, Grantz H, Findley DB, Katsovich L, Otka J, Lombroso PJ, King RA, Leckman JF. Assessment of symptom exacerbations in a longitudinal study of children with Tourette's syndrome or obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1070-7. — View Citation

Scahill L, Chappell PB, King RA, Leckman JF. Pharmacologic treatment of tic disorders. Child Adolesc Psychiatr Clin N Am. 2000 Jan;9(1):99-117. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tic severity		Measured at Week 10	No
Secondary	Tic-related impairment		Measured at Week 10	No
Secondary	Depressive symptoms		Measured at Week 10	Yes
Secondary	Anxiety symptoms		Measured at Week 10	No
Secondary	Obsessive-compulsive symptoms		Measured at Week 10	No

External Links

•   Click here for the Tic Disorders Clinic & Research Unit at the Massachusetts General Hospital/Harvard Medical School
•   Click here for the Tourette Syndrome Association Web site
•   Click here for the TS/OCD Specialty Clinic at the Yale Child Study Center