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| Tracking Information | |||||
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| First Received Date ICMJE | September 30, 2005 | ||||
| Last Updated Date | July 9, 2009 | ||||
| Start Date ICMJE | October 2005 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Tic severity [ Time Frame: Measured at Week 10 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Tic severity; measured at Week 10 | ||||
| Change History | Complete list of historical versions of study NCT00231985 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder | ||||
| Official Title ICMJE | Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder | ||||
| Brief Summary | This study will compare the efficacy of supportive therapy versus habit-reversal therapy for the treatment of Tourette syndrome and chronic tic disorder. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | June 2010 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00231985 | ||||
| Responsible Party | Sabine Wilhelm, PhD, Massachusetts General Hospital; Harvard medical school | ||||
| Study ID Numbers ICMJE | R01 MH069877, DSIR 83-ATAS | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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