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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00231985 |
This study will compare the effectiveness of supportive therapy versus habit-reversal therapy for the treatment of Tourette syndrome and chronic tic disorder.
Condition | Intervention | Phase |
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Tourette Syndrome Tic Disorders |
Behavioral: Habit reversal therapy Behavioral: Supportive therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder |
Estimated Enrollment: | 120 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Participants will receive supportive psychotherapy.
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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).
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2: Active Comparator
Participants will receive habit reversal therapy.
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Behavioral: Habit reversal therapy
Habit reversal therapy consists of awareness training, relaxation training, self-monitoring, and competing response training.
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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 effectiveness 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 educated 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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shana Franklin, BA | 617-724-4354 | sfranklin2@partners.org |
United States, Connecticut | |
Yale Child Study Center, Yale University | Recruiting |
New Haven, Connecticut, United States, 06520-7900 | |
Contact: Joe McGuire, BA 203-785-5805 joseph.mcguire@yale.edu | |
Principal Investigator: Larry Scahill, PhD | |
United States, Massachusetts | |
OCD Clinic/Psychiatry, Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Shana Franklin, BA 617-724-4354 tics@partners.org | |
Principal Investigator: Sabine Wilhelm, PhD | |
United States, Texas | |
University of Texas Health Sciences Center | Recruiting |
San Antonio, Texas, United States, 78229-3900 | |
Contact: Christin Pasker, BA 210-562-5411 pasker@uthscsa.edu | |
Principal Investigator: Alan Peterson, PhD |
Principal Investigator: | Sabine Wilhelm, PhD | MGH/Harvard Medical School |
Responsible Party: | MGH/Harvard medical school ( Sabine Wilhelm PhD ) |
Study ID Numbers: | R01 MH69877, DSIR 83-ATAS |
Study First Received: | September 30, 2005 |
Last Updated: | October 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00231985 |
Health Authority: | United States: Federal Government |
Habit-reversal Therapy Behavior Therapy Supportive Therapy |
Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Tourette Syndrome Tic Disorders Neurodegenerative Diseases Brain Diseases Dyskinesias Tics |
Signs and Symptoms Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Movement Disorders Mental Disorders Mental Disorders Diagnosed in Childhood Neurologic Manifestations Gilles de la Tourette's syndrome |
Pathologic Processes Disease Syndrome Nervous System Diseases |