Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00231985|
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : February 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tourette Syndrome Tic Disorders||Behavioral: Habit reversal therapy Behavioral: Supportive therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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.
- Tic severity [ Time Frame: Measured at Week 10 ]
- Tic-related impairment [ Time Frame: Measured at Week 10 ]
- Depressive symptoms [ Time Frame: Measured at Week 10 ]
- Anxiety symptoms [ Time Frame: Measured at Week 10 ]
- Obsessive-compulsive symptoms [ Time Frame: Measured at Week 10 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231985
|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|