NCT00231985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2005

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

4.4 years

First QC Date

September 30, 2005

Last Update Submit

February 8, 2012

Conditions

Tourette SyndromeTic Disorders

Keywords

Habit-reversal TherapyBehavior TherapySupportive Therapy

Outcome Measures

Primary Outcomes (1)

  • Tic severity

    Measured at Week 10

Secondary Outcomes (4)

  • Tic-related impairment

    Measured at Week 10

  • Depressive symptoms

    Measured at Week 10

  • Anxiety symptoms

    Measured at Week 10

  • Obsessive-compulsive symptoms

    Measured at Week 10

Study Arms (2)

1

PLACEBO COMPARATOR

Participants will receive supportive psychotherapy.

Behavioral: Supportive therapy

2

ACTIVE COMPARATOR

Participants will receive habit reversal therapy.

Behavioral: Habit reversal therapy

Interventions

Habit reversal therapyBEHAVIORAL

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

2
Supportive therapyBEHAVIORAL

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).

1

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale Child Study Center, Yale University

New Haven, Connecticut, 06520-7900, United States

Location

OCD Clinic/Psychiatry, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Texas Health Sciences Center

San Antonio, Texas, 78229-3900, United States

Location

Related Publications (11)

  • 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.

    PMID: 12218428BACKGROUND

  • 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.

    PMID: 2895987BACKGROUND

  • 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.

    PMID: 10674192BACKGROUND

  • 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.

    PMID: 29729555DERIVED

  • 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.

    PMID: 29029679DERIVED

  • 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.

    PMID: 28202705DERIVED

  • 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.

    PMID: 26763495DERIVED

  • 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.

    PMID: 25988365DERIVED

  • 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.

    PMID: 24144615DERIVED

  • 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.

    PMID: 24001701DERIVED

  • 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.

    PMID: 22868933DERIVED

Related Links

MeSH Terms

Conditions

Tourette SyndromeTic Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sabine Wilhelm, PhD

    MGH/Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

October 1, 2005

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

US(3)