Internet-based Cognitive Behavioral Therapy for Chronic Tic Disorder and Tourette's Disorder: a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Yale Global Tic Severity Scale (YGTSS)
研究概览
简要总结
Tic disorders, including Tourette's Disorder (TD) and Chronic Motor or Vocal Tic Disorder (CTD), are neurodevelopmental motor disorders characterised by motor and/or vocal tics. TD/CTD are impairing conditions with onset during childhood that often persist into adulthood. Behaviour therapy (BT) is an effective treatment for TD/CTD and is recommended as a first-line intervention in both in children and in adults. However, most adults with TD/CTD do not have access to BT due to a lack of trained professionals and geographical barriers. The objective of the study is to adapt and extend existing face-to-face BT treatment protocols for adults with TD/CTD to an internet-delivered format and evaluate its feasibility and preliminary efficacy. A total of 30 adult TD/CTD adult patients deemed eligible for the study through the recruitment process involving both psychologist and physician assessment will be enrolled in the project. The 8-modues treatment program, mainly based on exposure with response prevention with addition of other techniques will be made available for the participants in a secure treatment platform. The participants will keep in touch with a therapist using two-ways written communication in the same platform. The therapist's role will be to introduce the treatment and its modules, give feedback on the homework assignments and open the new modules as well as monitor the participants psychiatric symptoms and activity in the plattform. The measures will include tic severity secifically and disease severity in general, anxiety and depression symptoms, quality of life, treatment credibility and therapeutic alliance. The measures will be administrated at baseline, min- and post-tretment, as well at 3 and 12 months follow-up. Upon completion, this project will be the first crucial step towards the implementation of internet-delivered behaviour therapy (I-BT) for adults with TD/CTD in regular health care.
详细描述
Background
TS (Tourette Syndrome) is characterized by multiple motor tics and one or more vocal tics that have persisted for at least one year since initial onset, whereas in Chronic Motor or Vocal Tic Disorder (CTD) either motor or vocal tics are present, but not both, during at least one year (1). It is a childhood-onset disorder that affects more boys than girls (4:1 ratio) with a prevalence of about 1% in children (2), of which a substantial proportion continue to experience impairing tics into adulthood (3,4,5). TS/CTD are associated with reduced quality of life (6), lower educational attainment (7), and increased risk for cardiovascular and metabolic disorders (8). Notably, individuals with TD/CTD have a four-fold increased risk of death by suicide and the risk is highest for those whose tics persist into adulthood (9). Thus, effective interventions and appropriate follow-up are crucial to prevent undesirable health consequences and societal costs.
Evidence-based treatments for Tourette's Disorder and Chronic Tic Disorder
Historically, the most common treatment for TS/CTD has been pharmacotherapy, specifically antipsychotics. However, pharmacological treatments are modestly efficacious in reducing tics and often have undesirable side effects such as tiredness or long-term metabolic problems (10). Non-drug treatments for TS/CTD are therefore attractive alternatives. Behavioural treatments acknowledge that tics have a biological origin but that their expression is influenced by contextual variables: feelings, sensations, situations or other triggers that occur before tics. CBT focuses on modifying environmental factors that influence tic severity and teaches patients specific skills they can use to better manage their tics (11). CBT for tics generally includes two main elements. First, the patient learns how to detect their tics on a daily basis. Secondly, the patient learns how to resist the tics. CBT for TS/CTD has shown to be effective against waiting list (12) and against an active control group (13-16), with sustained results up to one year after treatment completion (17, 18). Expert guidelines in Europe and elsewhere recommend CBT as the first-line treatment for TS/CTD (17, 18).
Preferred treatments are not available
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant should
- •be 18 years of age or older,
- •fulfill diagnostic criteria for Tourette's Disorder (from now on referred to as Tourette Syndrome; TS) or Persistent (Chronic) Motor or Vocal Tic Disorder (CTD) according to the DSM-5 diagnostic criteria,
- •have Total Tic Severity Score [TTSS] of >15, or >10 for individuals with motor or vocal tics only, in the past week as measured by the Yale Global Tic Severity Scale (YGTSS) (31) ,
- •be able to read and communicate in Swedish and
- •have regular access to a computer connected to the internet, sufficient technical skills to use the treatment platform, as well as a mobile phone to receive SMS.
排除标准
- •organic brain disorders, intellectual disability, psychosis, bipolar disorder, autism spectrum disorder, anorexia nervosa, or substance use disorders,
- •acute psychiatric problems such as severe depression or suicidal risk needing immediate psychiatric care,
- •severe tics causing immediate risk to the patients or others and requiring urgent medical attention,
- •previous CBT for tics of a minimum of 8 sessions with a qualified therapist within 12 months prior to assessment,
- •simultaneous psychological treatment for TS or CTD
- •initiation or adjustment of medication for tics within the last two months prior to assessment.
结局指标
主要结局
Yale Global Tic Severity Scale (YGTSS)
时间窗: For the primary outcome: change between baseline and three months follow-up with one additional in-between measures at post-tretment. Two additional follow-up measures at 6- and 12-months.
The YGTSS is made up of a semi-structured interview, followed by a questionnaire where individuals are asked to rate the severity of their Tic symptoms (both motor and vocal) in domains such as: number, frequency, intensity, complexity, and interference. There is also an impairment scale, where the individual rates how the Tic impacts on their daily life and activities. The Total Tic Severity Score has a range of 0-50, and the Global Severity Score has a range of 0- 100. A higher score on all scales suggests a more severe Tic, or a greater impact the Tic has on the person's life. Only the total tic severity core will be used as the primary outcome.
次要结局
- Yale Global Tic Severity Scale (YGTSS) - impairment scale(Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.)
- Sheehan Disability Scale (SDS)(Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.)
- Clinical Global Impression (CGI)(Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.)
- EuroQol 5-dimensions (EQ-5D)(Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.)
- Global Assessment of Functioning (GAF)(Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.)
- Montgomery-Asberg Depression Rating Scale (MADRS)(Weekly measurements starting a baseline through post-tretment. Two additional follow-up measures at 6- and 12-months.)
- Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL)(Change between baseline and three months follow-up with one additional in-between measure at post-tretment. Two additional follow-up measures at 6- and 12-months.)
研究者
Christian Rück
Professor
Karolinska Institutet