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Completed

NCT Number: NCT04594044

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

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.

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Key information

Conditions

Chronic Tic Disorder Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodevelopmental Disorders Tic Disorders

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tics training including habit reversal training and exposure response prevention

Behavioral

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 outcomes

  1. Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks and 68 weeks

    Time frame: Baseline,16 weeks, 24 weeks, 40 weeks, 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 outcomes

  1. Change of baseline Premonitory urge (PUTS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks

    Time frame: Baseline, 6 weeks, 16 weeks, 24 weeks, 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

  2. Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks

    Time frame: Baseline, 6 weeks, 16 weeks, 24 weeks, 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

Group Therapy Versus Individual Therapy in Children and Adolescents With Tourette Syndrome and Chronic Tic Disorder

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 20, 2020
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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