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Completed

NCT Number: NCT00231985

Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of 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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Child Study Center, Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Habit reversal therapy

Behavioral

Habit reversal therapy consists of awareness training, relaxation training, self-monitoring, and competing response training.

Supportive Therapy

Behavioral

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).

Primary outcomes

  1. Tic severity

    Time frame: Measured at Week 10

Secondary outcomes

  1. Tic-related impairment

    Time frame: Measured at Week 10

  2. Depressive symptoms

    Time frame: Measured at Week 10

  3. Anxiety symptoms

    Time frame: Measured at Week 10

  4. Obsessive-compulsive symptoms

    Time frame: Measured at Week 10

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Oct 4, 2005
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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