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Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder

Primary Purpose

Chronic Tic Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tics training including habit reversal training and exposure response prevention
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tic Disorder focused on measuring Habit reversal training, Exposure response prevention, Children and adolescents

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A primary diagnosis of either Tourette syndrome or a chronic motor/vocal tics disorder
  • Moderate or greater severity corresponding to a total score on the Yale Global Tic Severity Scale (YGTSS) higher than 13 (higher than nine if only motor or vocal tics were described)

Exclusion Criteria:

  1. Disorders that required immediate treatment

    • psychotic disorder
    • primary severe depression
    • suicidal ideation or attempts
    • primary severe anorexia nervosa
  2. Disorders that makes participation difficult

    • IQ below 70
    • a life-time diagnosis of pervasive developmental disorder
  3. Treatment with HRT or ERP during the last six months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Individual HRT and ERP

    Group HRT and ERP

    Arm Description

    Individual treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol

    Group treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol

    Outcomes

    Primary Outcome Measures

    Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks and 68 weeks
    Measures the change in Total tic score and functional impairment at different end points on the Yale Global Tic Severity Scale (unabbreviated scale title). Interval 0-100, high score means a worse outcome

    Secondary Outcome Measures

    Change of baseline Premonitory urge (PUTS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks
    Measures the change of baseline premonitory urge score at different end points on the Premonitory Urge scale (unabbreviated scale title). Interval 1-4, high score means a worse outcome
    Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks
    Measures the change of baseline Beliefs About Tics Scale score at different end points on the Beliefs About Tics Scale (unabbreviated scale title). Interval 1-4, high score means a worse outcome

    Full Information

    First Posted
    October 13, 2020
    Last Updated
    July 20, 2021
    Sponsor
    Aarhus University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04594044
    Brief Title
    Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder
    Official Title
    Group Therapy Versus Individual Therapy in Children and Adolescents With Tourette Syndrome and Chronic Tic Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2015 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aarhus University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Chronic tic disorder (CTD) may have a huge impact on life quality. Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) are effective therapeutic modalities. This study examined the effect of a combined treatment using both HRT and ERP in children and adolescents with CTD. The treatment outcome was examined as an individual treatment compared to a group setting. There was no control group. The study examined both acute outcome and outcome at one year of follow-up. Predictive factors for treatment outcome were evaluated.
    Detailed Description
    Chronic tic disorder (CTD) may have a huge impact on life quality. Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) are known to be effective therapeutic modalities. Little is known about the effect of group therapy, the effect of combining HRT and ERP training, and of the long-term effect of treatment. This study therefore wanted to examine the effect of a combined treatment using both HRT and ERP in children and adolescents with CTD. The participants were randomized to treatment either in groups or in an individual setting. The parents were included in the training programme. The participants were asked to fulfill questionnaires concerning anxiety, mood, life quality, their thoughts about tics and the experienced premonitory urge. Furthermore, they were interviewed with the semistructured interview Yale Global Tic Severity Scale (YGTSS). Data was obtained from patient files as to examine possible predictors of both acute and long-term treatment effects. The evaluators were a specialized psychologist and a child and adolescent psychiatrist with several years of experience in diagnosing, evaluating and treating tic disorders. A random sample of 10% were audiotaped and evaluated by another rater with extensive experience and expertise in the use of the YGTSS. The evaluator was not blinded to the treatment allocation, yet not involved in the treatment of the patient, and blinded to any previous evaluations

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Tic Disorder
    Keywords
    Habit reversal training, Exposure response prevention, Children and adolescents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    In an open randomized controlled study, youth were randomized to either individualized, or group treatment. Both therapies included nine sessions, and the parents were offered one group-session. Treatment effect was evaluated after 8 and 9 months, and after one year of follow-up
    Masking
    Outcomes Assessor
    Masking Description
    Evaluations of treatment response were made by an independent evaluator who was not blinded to the treatment allocation, yet not involved in the treatment of the patient, and blinded to any previous evaluations. The evaluators were a specialized psychologist and a child and adolescent psychiatrist with several years of experience in diagnosing, evaluating and treating tic disorders. A random sample of 10% were audiotaped and evaluated by another rater with extensive experience and expertise in the use of the YGTSS
    Allocation
    Randomized
    Enrollment
    59 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Individual HRT and ERP
    Arm Type
    Experimental
    Arm Description
    Individual treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol
    Arm Title
    Group HRT and ERP
    Arm Type
    Experimental
    Arm Description
    Group treatment with habit reversal training (HRT) and exposure response prevention (ERP) according to a protocol
    Intervention Type
    Behavioral
    Intervention Name(s)
    tics training including habit reversal training and exposure response prevention
    Intervention Description
    In an open randomized controlled study, youth were randomized to either individualized, or group treatment. Both therapies included nine sessions, and the parents were offered one group-session.
    Primary Outcome Measure Information:
    Title
    Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks and 68 weeks
    Description
    Measures the change in Total tic score and functional impairment at different end points on the Yale Global Tic Severity Scale (unabbreviated scale title). Interval 0-100, high score means a worse outcome
    Time Frame
    Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks
    Secondary Outcome Measure Information:
    Title
    Change of baseline Premonitory urge (PUTS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks
    Description
    Measures the change of baseline premonitory urge score at different end points on the Premonitory Urge scale (unabbreviated scale title). Interval 1-4, high score means a worse outcome
    Time Frame
    Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks
    Title
    Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks
    Description
    Measures the change of baseline Beliefs About Tics Scale score at different end points on the Beliefs About Tics Scale (unabbreviated scale title). Interval 1-4, high score means a worse outcome
    Time Frame
    Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A primary diagnosis of either Tourette syndrome or a chronic motor/vocal tics disorder Moderate or greater severity corresponding to a total score on the Yale Global Tic Severity Scale (YGTSS) higher than 13 (higher than nine if only motor or vocal tics were described) Exclusion Criteria: Disorders that required immediate treatment psychotic disorder primary severe depression suicidal ideation or attempts primary severe anorexia nervosa Disorders that makes participation difficult IQ below 70 a life-time diagnosis of pervasive developmental disorder Treatment with HRT or ERP during the last six months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Judith Nissen
    Organizational Affiliation
    Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Aarhus, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    In accordance to Danish law, personal data cannot be shared
    Citations:
    PubMed Identifier
    33610169
    Citation
    Nissen JB, Carlsen AH, Thomsen PH. One-year outcome of manualised behavior therapy of chronic tic disorders in children and adolescents. Child Adolesc Psychiatry Ment Health. 2021 Feb 20;15(1):9. doi: 10.1186/s13034-021-00362-w.
    Results Reference
    derived

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    Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder

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