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临床试验/NCT04594044
NCT04594044已完成不适用

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

Aarhus University Hospital0 个研究点目标入组 59 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
主要终点
Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks and 68 weeks

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
9 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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

次要结局

  • Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks(Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks)
  • Change of baseline Premonitory urge (PUTS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks(Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Judith Becker Nissen

MD, PhD, senior researcher

Aarhus University Hospital

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