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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00231985
First received: September 30, 2005
Last updated: February 8, 2012
Last verified: February 2012

September 30, 2005
February 8, 2012
October 2005
March 2010   (final data collection date for primary outcome measure)
Tic severity [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
Tic severity; measured at Week 10
Complete list of historical versions of study NCT00231985 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder
Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Tourette Syndrome
  • Tic Disorders
  • Behavioral: Habit reversal therapy
    Habit reversal therapy consists of awareness training, relaxation training, self-monitoring, and competing response training.
  • 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).
  • Placebo Comparator: 1
    Participants will receive supportive psychotherapy.
    Intervention: Behavioral: Supportive therapy
  • Active Comparator: 2
    Participants will receive habit reversal therapy.
    Intervention: Behavioral: Habit reversal therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231985
R01 MH069877, R01MH069877, DSIR 83-ATAS
Not Provided
Sabine Wilhelm, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Sabine Wilhelm, PhD MGH/Harvard Medical School
Massachusetts General Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP