Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00231985
Collaborator
National Institute of Mental Health (NIMH) (NIH)
122
3
2
53
40.7
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Habit reversal therapy
  • Behavioral: Supportive therapy
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder
Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Tic severity [Measured at Week 10]

Secondary Outcome Measures

  1. Tic-related impairment [Measured at Week 10]

  2. Depressive symptoms [Measured at Week 10]

  3. Anxiety symptoms [Measured at Week 10]

  4. Obsessive-compulsive symptoms [Measured at Week 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Yale Child Study Center, Yale University New Haven Connecticut United States 06520-7900
2 OCD Clinic/Psychiatry, Massachusetts General Hospital Boston Massachusetts United States 02114
3 University of Texas Health Sciences Center San Antonio Texas United States 78229-3900

Sponsors and Collaborators

  • Massachusetts General Hospital
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Sabine Wilhelm, PhD, MGH/Harvard Medical School

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Sabine Wilhelm, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00231985
Other Study ID Numbers:
  • R01MH069877
  • R01MH069877
  • DSIR 83-ATAS
First Posted:
Oct 4, 2005
Last Update Posted:
Feb 9, 2012
Last Verified:
Feb 1, 2012
Keywords provided by Sabine Wilhelm, PhD, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2012