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

Primary Purpose

Tourette Syndrome, Tic Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Habit reversal therapy
Supportive therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Habit-reversal Therapy, Behavior Therapy, Supportive Therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Child Study Center, Yale University
  • OCD Clinic/Psychiatry, Massachusetts General Hospital
  • University of Texas Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive supportive psychotherapy.

Participants will receive habit reversal therapy.

Outcomes

Primary Outcome Measures

Tic severity

Secondary Outcome Measures

Tic-related impairment
Depressive symptoms
Anxiety symptoms
Obsessive-compulsive symptoms

Full Information

First Posted
September 30, 2005
Last Updated
February 8, 2012
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00231985
Brief Title
Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder
Official Title
Behavior Therapy and Psychosocial Treatment for Tourette Syndrome and Chronic Tic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Tic Disorders
Keywords
Habit-reversal Therapy, Behavior Therapy, Supportive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Participants will receive supportive psychotherapy.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive habit reversal therapy.
Intervention Type
Behavioral
Intervention Name(s)
Habit reversal therapy
Intervention Description
Habit reversal therapy consists of awareness training, relaxation training, self-monitoring, and competing response training.
Intervention Type
Behavioral
Intervention Name(s)
Supportive therapy
Intervention Description
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 Outcome Measure Information:
Title
Tic severity
Time Frame
Measured at Week 10
Secondary Outcome Measure Information:
Title
Tic-related impairment
Time Frame
Measured at Week 10
Title
Depressive symptoms
Time Frame
Measured at Week 10
Title
Anxiety symptoms
Time Frame
Measured at Week 10
Title
Obsessive-compulsive symptoms
Time Frame
Measured at Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
MGH/Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center, Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-7900
Country
United States
Facility Name
OCD Clinic/Psychiatry, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12218428
Citation
Lin H, Yeh CB, Peterson BS, Scahill L, Grantz H, Findley DB, Katsovich L, Otka J, Lombroso PJ, King RA, Leckman JF. Assessment of symptom exacerbations in a longitudinal study of children with Tourette's syndrome or obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1070-7. doi: 10.1097/00004583-200209000-00007.
Results Reference
background
PubMed Identifier
2895987
Citation
Bruun RD. Subtle and underrecognized side effects of neuroleptic treatment in children with Tourette's disorder. Am J Psychiatry. 1988 May;145(5):621-4. doi: 10.1176/ajp.145.5.621.
Results Reference
background
PubMed Identifier
10674192
Citation
Scahill L, Chappell PB, King RA, Leckman JF. Pharmacologic treatment of tic disorders. Child Adolesc Psychiatr Clin N Am. 2000 Jan;9(1):99-117.
Results Reference
background
PubMed Identifier
29729555
Citation
Weingarden H, Scahill L, Hoeppner S, Peterson AL, Woods DW, Walkup JT, Piacentini J, Wilhelm S. Self-esteem in adults with Tourette syndrome and chronic tic disorders: The roles of tic severity, treatment, and comorbidity. Compr Psychiatry. 2018 Jul;84:95-100. doi: 10.1016/j.comppsych.2018.04.008. Epub 2018 Apr 23.
Results Reference
derived
PubMed Identifier
29029679
Citation
Houghton DC, Capriotti MR, Scahill LD, Wilhelm S, Peterson AL, Walkup JT, Piacentini J, Woods DW. Investigating Habituation to Premonitory Urges in Behavior Therapy for Tic Disorders. Behav Ther. 2017 Nov;48(6):834-846. doi: 10.1016/j.beth.2017.08.004. Epub 2017 Aug 10.
Results Reference
derived
PubMed Identifier
28202705
Citation
Sukhodolsky DG, Woods DW, Piacentini J, Wilhelm S, Peterson AL, Katsovich L, Dziura J, Walkup JT, Scahill L. Moderators and predictors of response to behavior therapy for tics in Tourette syndrome. Neurology. 2017 Mar 14;88(11):1029-1036. doi: 10.1212/WNL.0000000000003710. Epub 2017 Feb 15.
Results Reference
derived
PubMed Identifier
26763495
Citation
Peterson AL, McGuire JF, Wilhelm S, Piacentini J, Woods DW, Walkup JT, Hatch JP, Villarreal R, Scahill L. An Empirical Examination of Symptom Substitution Associated With Behavior Therapy for Tourette's Disorder. Behav Ther. 2016 Jan;47(1):29-41. doi: 10.1016/j.beth.2015.09.001. Epub 2015 Sep 11.
Results Reference
derived
PubMed Identifier
25988365
Citation
McGuire JF, Piacentini J, Scahill L, Woods DW, Villarreal R, Wilhelm S, Walkup JT, Peterson AL. Bothersome tics in patients with chronic tic disorders: Characteristics and individualized treatment response to behavior therapy. Behav Res Ther. 2015 Jul;70:56-63. doi: 10.1016/j.brat.2015.05.006. Epub 2015 May 12.
Results Reference
derived
PubMed Identifier
24144615
Citation
McGuire JF, Nyirabahizi E, Kircanski K, Piacentini J, Peterson AL, Woods DW, Wilhelm S, Walkup JT, Scahill L. A cluster analysis of tic symptoms in children and adults with Tourette syndrome: clinical correlates and treatment outcome. Psychiatry Res. 2013 Dec 30;210(3):1198-204. doi: 10.1016/j.psychres.2013.09.021. Epub 2013 Sep 27.
Results Reference
derived
PubMed Identifier
24001701
Citation
Jeon S, Walkup JT, Woods DW, Peterson A, Piacentini J, Wilhelm S, Katsovich L, McGuire JF, Dziura J, Scahill L. Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods. Contemp Clin Trials. 2013 Nov;36(2):414-20. doi: 10.1016/j.cct.2013.08.012. Epub 2013 Aug 31.
Results Reference
derived
PubMed Identifier
22868933
Citation
Wilhelm S, Peterson AL, Piacentini J, Woods DW, Deckersbach T, Sukhodolsky DG, Chang S, Liu H, Dziura J, Walkup JT, Scahill L. Randomized trial of behavior therapy for adults with Tourette syndrome. Arch Gen Psychiatry. 2012 Aug;69(8):795-803. doi: 10.1001/archgenpsychiatry.2011.1528.
Results Reference
derived
Links:
URL
http://tsa-usa.org
Description
Click here for the Tourette Syndrome Association Web site
URL
http://www.mghocd.org/tics
Description
Click here for the Tic Disorders Clinic & Research Unit at the Massachusetts General Hospital/Harvard Medical School
URL
http://info.med.yale.edu/chldstdy/tsocd/
Description
Click here for the TS/OCD Specialty Clinic at the Yale Child Study Center

Learn more about this trial

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

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