Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00231985

Purpose

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

Condition	Intervention	Phase
Tourette Syndrome Tic Disorders	Behavioral: Habit reversal therapy Behavioral: Supportive therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome

MedlinePlus related topics: Anxiety Tourette Syndrome

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Tic severity [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tic-related impairment [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
Depressive symptoms [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: Yes ]
Anxiety symptoms [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
Obsessive-compulsive symptoms [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]

Enrollment:	122
Study Start Date:	October 2005
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Participants will receive supportive psychotherapy.	Behavioral: 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).
Active Comparator: 2 Participants will receive habit reversal therapy.	Behavioral: Habit reversal therapy Habit reversal therapy consists of awareness training, relaxation training, self-monitoring, and competing response training.

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231985

Locations

United States, Connecticut
Yale Child Study Center, Yale University
New Haven, Connecticut, United States, 06520-7900
United States, Massachusetts
OCD Clinic/Psychiatry, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Texas
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229-3900

Sponsors and Collaborators

Massachusetts General Hospital

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Sabine Wilhelm, PhD

MGH/Harvard Medical School

More Information

Additional Information:

Click here for the Tourette Syndrome Association Web site This link exits the ClinicalTrials.gov site

Click here for the Tic Disorders Clinic & Research Unit at the Massachusetts General Hospital/Harvard Medical School This link exits the ClinicalTrials.gov site

Click here for the TS/OCD Specialty Clinic at the Yale Child Study Center This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

Responsible Party:	Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00231985 History of Changes
Other Study ID Numbers:	R01 MH069877, R01MH069877, DSIR 83-ATAS
Study First Received:	September 30, 2005
Last Updated:	February 8, 2012
Health Authority:	United States: Federal Government

Keywords provided by Massachusetts General Hospital:

Habit-reversal Therapy
Behavior Therapy
Supportive Therapy

Additional relevant MeSH terms:

Tic Disorders
Tics
Tourette Syndrome
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders

Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 12, 2012