Randomised Controlled Trial of Acceptance and Commitment Therapy in Tuberous Sclerosis Complex
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Treatment completion rate
研究概览
简要总结
The study will assess the acceptability and feasibility of a randomised controlled trial of 6-12 sessions of remotely-delivered Acceptance and Commitment Therapy (ACT) versus waitlist control. Waitlist control will involve a delay in the offer of ACT sessions for 12 weeks. Participants may access all services as usual in this time. Follow-up assessments will be conducted at 12-, 24 and 48 weeks post-randomisation to measure effectiveness.
详细描述
Tuberous Sclerosis Complex (TSC) is a genetic disease caused by mutations in the tumour suppressor genes TSC1 and TSC2. The clinical hallmarks of the disease are the growth of benign tumours in various organs such as the brain, kidneys and skin. Seizures are present in around 60% of the population and neurodevelopmental problems such as attention deficit disorder and autism are common. Anxiety and depressive disorders are similarly linked and at the psychosocial level, there is increasing evidence of the effect of TSC on self-esteem, family functioning and peer relationships resulting in poorer quality of life. Despite these difficulties, no unique treatments, and almost no effective evidenced psychological treatments for TSC are available.
This trial aims to assess the feasibility and acceptability of Acceptance and Commitment Therapy (ACT) as a psychological treatment to improve quality of life among adolescents and young adults with TSC. ACT is a cognitive behavioural therapy that helps participants accept difficulties that they are unable to change. There is strong evidence for ACT's clinical effectiveness amongst patients with chronic diseases. The intervention will be delivered to participants aged 11-24 with TSC and sufficient cognitive and speech capabilities to take part. This will be delivered remotely via secure video-conferencing software. Our primary hypothesis is that ACT will be acceptable and feasible delivered remotely and may yield clinical improvements in health and quality of life.
The study will be a 12-week, waitlist controlled randomised clinical trial. Participants will be randomised to receive 12-weeks treatment either immediately or following a 12-week wait. The treatment will be ACT adapted for 11-24-year olds who have TSC. Treatment will involve 6 to 12 weekly sessions of ACT of up to one hour each in length. Clinical outcomes will be assessed unblinded at baseline, 12, 24 and 48 weeks from randomisation. As a feasibility and acceptability study a range of physical and mental health outcomes are assessed. All clinical outcomes focus on health, wellbeing and quality of life from baseline to 12 week (3-month) follow-up amongst those offered ACT immediately versus waitlist controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study design is an unblinded, waitlist-controlled, randomised controlled trial (RCT). Randomisation will be conducted using established randomisation software RedCap. Researchers will not be blind to trial arm allocation.
入排标准
- 年龄范围
- 11 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 11 to 24 years.
- •Diagnosis of Tuberous Sclerosis Complex.
- •Sufficient understanding of English to engage with the intervention (spoken and written), as judged by the assessing clinician.
- •Sufficient cognitive, sensory and speech capabilities to take part in the intervention.
- •Participants (or their parents if under 16) give verbal or written informed consent to participate in the study.
- •Participants give verbal or written assent if under
- •Receiving treatment over video-conferencing will be the default modality for delivery, so access to the internet is a requirement.
排除标准
- •Previous structured behavioural intervention within last 6 months.
- •Previous or current alcohol/substance dependence, psychosis, suicidality, or anorexia nervosa.
- •Moderate or severe intellectual disability.
- •Immediate risk to self or others.
- •Parent or child not able to speak, read or write English.
结局指标
主要结局
Treatment completion rate
时间窗: Assessed at 6-month follow-up
The proportion of patients showing interest who then consent to the trial and complete the intervention.
Session attendance rate
时间窗: Assessed at 6-month follow-up
The session attendance rate compared to feasibility benchmarks.
The credibility/expectancy questionnaire
时间窗: Assessed at session 2
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
The experience of service questionnaire
时间窗: Assessed at 6-month follow-up
A questionnaire used nationally in child and adolescent mental health services completed by patients and parents/carers (if under 16) to assess participants' experience of the intervention. An additional item has been added to the experience of service questionnaire to assess video-conferencing treatment satisfaction. Minimum score = 0; maximum score = 20. Higher scores indicate better outcome.
次要结局
- Acceptance and Action Questionnaire II(Assessed at 3, 6 and 12-month follow-up.)
- World Health Organisation wellbeing index 5-items(Assessed at 3, 6 and 12-month follow-up.)
- Experiential interviews(Assessed at 3- and 6-month follow-up)
- Avoidance and Fusion Questionnaire for Youth 8-items(Assessed at 3, 6 and 12-month follow-up.)
- Generalised Anxiety Disorder assessment 7-items(Assessed at 3, 6 and 12-month follow-up.)
- Patient Health Questionnaire 9-items(Assessed at 3, 6 and 12-month follow-up.)
- TAND - TSC Associated Neuropsychiatric Disorders(Assessed at 3, 6 and 12-month follow-up.)
- Client Service Receipt Inventory(Assessed at 3, 6 and 12-month follow-up.)
- Pediatric Quality of Life Inventory (PedsQL)(Assessed at 3, 6 and 12-month follow-up.)