A Parallel-group, Randomized Controlled Trial of Internet-based Behavior Therapy for Adults With Tourette Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS)
研究概览
简要总结
This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention.
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)
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
- •≥ 18 years of age.
- •Primary diagnosis of TS/CTD, according to criteria in Diagnostic and Statistical Manual of mental disorders 5th edition.
- •Provided digital informed consent.
- •Have a Total Tic Severity Score (TTS) 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).
- •Being willing and able to follow the study procedures and participate in the 10-week treatment program.
- •Being fluent in Swedish.
- •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 text messages.
排除标准
- •Ongoing or planned psychological treatment for TS/CTD.
- •Previous BT for tics of a minimum of 8 sessions with a qualified therapist within 12 months prior to assessment.
- •Adjustment of medication for tics within the last two months prior to assessment.
- •Severe psychiatric comorbidities such as organic brain disorders, bipolar disorder, ongoing psychosis, anorexia nervosa or substance use disorders that can interfere with the treatment for TS/CTD.
- •Acute psychiatric problems such as severe depression or suicidal risk needing immediate psychiatric care.
- •Severe tics causing immediate risk to the participants themselves or to others and requiring urgent medical attention.
结局指标
主要结局
Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS)
时间窗: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
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. The Total Tic Severity subscale has a range of 0-50. A higher score suggests higher tic severity.
次要结局
- Yale Global Tic Severity Scale (YGTSS) - impairment scale(Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.)
- Adult Tic Questionnaire (ATQ)(Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start.)
- Montgomery-Asberg Depression Rating Scale (MADRS)(Baseline, week 3, 7, 11 (primary end-point), 23 and 14 months after the treatment start.)
- Treatment Inventory of Costs in Psychiatric Patients (TIC-P)(Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.)
- Work and social adjustment scale (WSAS)(Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start.)
- Assessing Quality of Life 6 Dimensions (AQoL-6D)(Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.)
- Clinical Global Impression (CGI)(Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.)
- Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL)(Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.)
研究者
Ekaterina Ivanova
Postdoctoral researcher
Karolinska Institutet