Internet-based Behaviour Therapy for Tourette's Disorder and Chronic Tic Disorder: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Yale Global Tic Severity Scale (YGTSS)
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and acceptability of two different modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD).
详细描述
The primary objective of this study is to evaluate the feasibility and acceptability of two different modalities of therapist-guided Internet-delivered behaviour therapy (IBT) for children and adolescents (7-17 years) with Tourette's Disorder (TD) or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD). The two modalities of IBT are habit reversal training (HRT) and exposure and response prevention (ERP). Secondary objectives are to evaluate whether IBT can decrease tic frequency and tic-related impairment, and, as both HRT and ERP have been proven efficacious in treating TD/PTD face-to-face, are any of the two treatments better suited to be delivered via the internet?
The design of the study is a randomized-controlled trial with 20 participants. Participants will be stratified by ADHD/ADD status.
The treatment duration is 10 weeks.
Feasibility and acceptability will be assumed if:
- The two treatments can be successfully adapted to a therapist guided internet-delivered format (technical feasibility)
- Patients/parents are willing to try the offered treatment modalities
- Participants complete the active parts of the treatment
- Referrers are open to the idea of internet-delivered treatment for TD or PTD
- We can recruit sufficient numbers of patients for a fully powered efficacy trial
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill DSM-5 diagnostic criteria for Tourette's Disorder or Persistent (Chronic) Motor or Vocal Tic Disorder (PTD).
- •>15 (TD) or >10 (PTD) on Yale Global Tic Severity Scale (Impairment not included).
- •Both child and parent are able to read and communicate in Swedish.
- •Regular access to a computer and the Internet.
- •Parent availability to support their child throughout the treatment.
排除标准
- •Acute psychiatric problems such as severe depression, suicidal risk, substance abuse or another psychiatric disorder that could interfere with treatment.
- •Lifetime history of global learning disability, pervasive developmental disorder, psychosis, bipolar disorder or organic brain disorder.
- •Severe tics causing immediate risk to the patients or others and requiring urgent medical attention.
- •Previous behavioural therapy (HRT or ERP), minimum 8 sessions with qualified therapist, within the last 12 months prior to assessment.
- •Simultaneous psychological treatment for tic disorder.
- •Initiation or adjustment of any psychotropic medication for tics within the last 6 weeks prior to assessment.
研究组 & 干预措施
I-HRT
Internet-delivered habit reversal training
干预措施: Internet-delivered habit reversal training (Behavioral)
I-ERP
Internet-delivered exposure and response prevention
干预措施: Internet-delivered exposure and response prevention (Behavioral)
结局指标
主要结局
Yale Global Tic Severity Scale (YGTSS)
时间窗: Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up
Change in tic severity (motor and/or vocal tics) from week 0 (pre treatment) to week 10 (post treatment), 3 months follow up (after post treatment), 6 months follow up and 12 months follow up.
次要结局
- Obsessive-Compulsive Inventory - Child version (OCI-CV).(Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Mood and Feeling Questionnaire - Short version (MFQ)(Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Children's Global Assessment Scale (C-GAS)(Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)(Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Treatment satisfaction scale(Week 10)
- Children's Depression Inventory - Short version (CDI-S), with additional suicidality item(Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Treatment credibility scale(Week 3)
- Safety Monitoring Uniform Report Form (SMURF)(Week 5; week 10)
- Internet Intervention Patient Adherence Scale (iiPAS)(Week 5; week 10)
- Gilles de la Tourette Syndrome Quality of Life Scale (GTS-QOL).(Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Clinical Global Impression - Severity (CGI-S)(Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Clinical Global Impression - Improvement (CGI-I)(Week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Parent Tic Questionnaire (PTQ)(Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Premonitory urge for Tics Scale (PUTS)(Week 0; week 5; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Education, Work and Social Adjustment Scale - Child version (EWSAS-C)(Week 0; week 10; 3 months follow up; 6 months follow up; 12 months follow up)
- Parental strategy scale(Week 10)
研究者
David Mataix-Cols
Professor
Karolinska Institutet