Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Yale Global Tic Severity Scale (YGTSS)
研究概览
简要总结
It is a randomized controlled trial to compare two behavioural treatments, namely CBIT and CoPs. This study would be the first head-to-head randomized trial between two established treatments rather than supportive counseling or wait-list control. Thirty-six adults and 36 children with TS/TD will be recruited into each of the two (CBIT, CoPs) modalities requiring a total recruitment of 72 adults and 72 children over 5 years, which permits, even for a small-medium effect size, a robust power calculation. Motor performance measures will give concurrent validity to changes pre-post in TS/TD motor processes. Recruitment of both males and females will permit sex comparisons. The participants meeting inclusion/exclusion criteria will be assessed at pre-post 1 month and 6 months following treatment on standardized tic scales and global assessment of functioning. Participants will be treated individually on a weekly basis by therapists with an allegiance to each modality and outcome assessed by masked evaluation. The treatments are manualized and will last 10 weeks with 4 weeks of home practice at post-treatment with 6-month follow-up assessment on all outcome measures, plus motor performance measures post-treatment. All treatment sessions will be audio-recorded and assessed with implementation of treatment integrity procedures scales. The hypotheses are that: (1) the CoPs group will show superiority in clinically significant improvement on standard tic scale score, global functioning and quality of life than the CBIT group; and (2) changes in recognized parameters on selected motor tests scored according to published norms will change towards normalization post CoPs but not post CBIT. The outcome data from the two treatments will be analyzed by a mixed linear model adaptation of repeated measures MANOVA and daily diary measures will allow for an additive time series design over the 10 weeks treatment session. This design will allow computation of the size of treatment effects at different stages of therapy. The study results will impact on the treatment of choice and access to treatment for tic disorders and on the conceptualization of tic disorders.
详细描述
Tics are defined as repetitive non-voluntary contractions of functionally related groups of skeletal muscles in one or more parts of the body. Gilles de la Tourette's syndrome (TS) forms a separate diagnostic category with multiple tics including vocal (phonic) tics occurring several times per day, for at least 1 year with onset before age 18. Persistent (chronic) tic disorder (TD) may involve a single motor or vocal tic. Tics peak around age 11 but can persist into adulthood with a prevalence of 1% and if untreated cause significant impairment. The current treatment guidelines for managing the tics recommend a Behavioural treatment, "habit reversal", which focuses on reversing the tic habit, now developed as a Comprehensive Behavioural Intervention for Tics (CBIT). CBIT involves multiple stages including awareness, relaxation, contingency training, positive reinforcement for not do the tic and the practice of a competing response antagonistic to the tic. A recent large scale multisite study compared CBIT with supportive therapy and found a significantly greater decrease in adults and children tics treated with CBIT. However, in both adult and child studies, 48-62% of samples were classified as non-responders. Effect sizes were medium (Cohen's d´= 0.55 - 0.68) compared to supportive therapy with mean tic decrease of 25-30% and samples remained symptomatic at follow-up. Research over the last 10 years (funded by the CIHR) have led to elaboration of a cognitive behavioural psychophysiological model of treatment (CoPs) of tic disorders. The CoPs is multi-modal and targets cognitive, behavioural and physiological processes characteristic of tic disorders rather than focusing on reversing the actual tic at onset. In the last funding period 2009-2013 the investigators have successfully applied the program to all subtypes and severity of adults with TS/TD both with and without comorbidity and compared outcome with a natural waitlist control. Results showed a clinically significant reduction of tic frequency following CoPs (Cohen's d- 1.43-2.34), maintained at 6-month follow-up. Validity of the CoPs model was supported by a change in behavioural and psychosocial as well as tic symptom measures post-treatment and at 6-month follow-up, and a post-treatment normalization of participants' performance on neuropsychological and electrophysiological measures.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessors will receive no information on participant history and psychopathology. All evaluation sessions will be audio-recorded for reliability and to ensure that treatment status is not divulged. The Assessors will be separated from the therapists by geographical location site and will sign agreements not to discuss cases in the study with any other team member. Child and adult participants will agree not to discuss treatment or therapy during evaluation. Management of assessors will be delegated to a separate clinical coordinator who will assume overall responsibility for evaluations and preempting any direct contact between the principal investigator and Co-investigators and the assessors.
入排标准
- 年龄范围
- 8 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presenting a simple/complex tic for at least one year occurring daily. Those included in the TS group, age 8-12 or 18-65, had a diagnosis of TS as the principal presenting problem accompanied by vocal tics. Those included in the TD group presented a simple/complex tic (vocal or motor) for at least one year occurring daily.
排除标准
- •any major medical history, head injury including sensori-motor impairment, history of autism, Intelligence Quotient (IQ)<75; other psychiatric problem on Axis I or II requiring treatment (minor comorbidities were accepted), any neurological problems (e.g., Parkinson's, hemifacial spasms, Meige syndrome, sclerosis; Huntington's disease, Wilson's disease); currently receiving treatment from a psychologist, acupuncture, hypnotherapist, massotherapist; currently receiving psychotropic drugs non-relevant to TS or ADHD or abuse of alcohol or drugs.
结局指标
主要结局
Yale Global Tic Severity Scale (YGTSS)
时间窗: baseline
The YGTSS is a clinician-rated scale used to assess change in tic severity and impairment due to tics.
次要结局
- determine style of planning actions(baseline)
- measure effect of therapy in style of planning score(change from baseline)
- measure long term effect of therapy in style of planning score(change from baseline at 6 months)
- change in dimensions of perfectionism and use as a predictive variable of treatment issues(baseline)
- change in dimensions of perfectionism(change from baseline)
- measure the long term effect on dimensions of perfectionism(change from baseline at 6 months)
- determine the initial score of symptom of anxiety use as a predictive variable of treatment issues(baseline)
- measure the effect of therapy on symptom of anxiety(change from baseline)
- measure the long term effect of therapy on symptom of anxiety(change from baseline at 6 months)
- determine an initial score of symptom of depression and use as a predictive variable of treatment issues(baseline)
- measure the effect of therapy on symptom of depression(change from baseline)
- measure the long term effect of therapy on symptom of depression(change from baseline at 6 months)
- measure the presence and the impact on treatment issues of major life events(change from baseline)
- measure the presence and the impact of major life events(change from baseline at 6 months)
- measure the effect of the therapy on Self-Esteem(change from baseline)
- measuring effect of therapy on quality of life(change from baseline)
- measuring effect of therapy on symptoms of ADHD(change from baseline)
- measuring long term effect of therapy on symptoms of ADHD(change from baseline at 6 months)
- evaluate long term post-therapy effects on level of self-esteem(change from baseline at 6 months)
- determine an initial score of individual self-esteem and use as a predictive variable of treatment issues(baseline)
- measure the long term effect of the therapy on Self-Esteem and use as a predictor of issues of treatment(change from baseline at 6 months)
- determine an initial score of individual motor and attentional impulsivity and use as a predictive variable of treatment issues(baseline)
- determine a baseline score of quality of life linked with Tourette syndrome(baseline)
- measuring long term effect of therapy on quality of life(change from baseline at 6 months)
- measuring initial symptoms of ADHD and use as a predictive variable of treatment issues(baseline)
- assessing change of symptom severity of obsessive-compulsive disorder (OCD)(change from baseline)
- determine an initial score of level of self-esteem use as a predictive variable of treatment issues(baseline)
- evaluate post-therapy effects on level of self-esteem(change from baseline)
- measure the effect of the therapy on motor and attentional impulsivity(change from baseline)
- measure the long term effect of the therapy on motor and attentional impulsivity(change from baseline at 6 months)
- assessing symptom severity of obsessive-compulsive disorder (OCD) and use as a predictive variable of treatment issues(baseline)
- assessing long term change of symptom severity of obsessive-compulsive disorder (OCD)(change from baseline at 6 months)
- change in the global measure of level of functionning in children, adolescents and adults(change from baseline at 6 months)
研究者
Frederick Aardema
Professeur titulaire
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal