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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


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
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