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

NCT ID: NCT00231985

Last Updated: 2012-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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 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.

Conditions

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Tourette Syndrome Tic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive supportive psychotherapy.

Group Type PLACEBO_COMPARATOR

Supportive therapy

Intervention Type 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).

2

Participants will receive habit reversal therapy.

Group Type ACTIVE_COMPARATOR

Habit reversal therapy

Intervention Type BEHAVIORAL

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

Interventions

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Habit reversal therapy

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

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sabine Wilhelm

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sabine Wilhelm, PhD

Role: PRINCIPAL_INVESTIGATOR

MGH/Harvard Medical School

Locations

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Yale Child Study Center, Yale University

New Haven, Connecticut, United States

Site Status

OCD Clinic/Psychiatry, Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Texas Health Sciences Center

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12218428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2895987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10674192 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29729555 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29029679 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28202705 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26763495 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25988365 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24144615 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24001701 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22868933 (View on PubMed)

Related Links

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http://tsa-usa.org

Click here for the Tourette Syndrome Association Web site

http://www.mghocd.org/tics

Click here for the Tic Disorders Clinic \& Research Unit at the Massachusetts General Hospital/Harvard Medical School

http://info.med.yale.edu/chldstdy/tsocd/

Click here for the TS/OCD Specialty Clinic at the Yale Child Study Center

Other Identifiers

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R01MH069877

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 83-ATAS

Identifier Type: -

Identifier Source: secondary_id

R01MH069877

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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