Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder
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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 2 |
| 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 |
- Tic severity [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| Principal Investigator: | Sabine Wilhelm, PhD | MGH/Harvard Medical School |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 May 23, 2013