Youth Metacognitive Therapy (YoMETA): A Single-Blind Parallel Randomised Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Revised Children Anxiety and Depression Scale - Short Version (RCADS)
研究概览
简要总结
One in eight children and young people (CYP) suffer mental health problems needing support or treatment and 5% have more than one such problem. The effects can be major, affecting CYP emotionally and functionally, impacting progress at school, relationships with others and increasing long term risk of mental health problems. Parents, schools, policy makers and the NHS often struggle to find the best way to help, especially within their limited budgets. The UK Government and the NHS have highlighted the need to improve mental health in CYP.
The most common treatment is cognitive behavioural therapy; however this can be time consuming, needs to be delivered over many weeks, must focus on the most upsetting problem first and is not very effective. One way to overcome this is to evaluate a group therapy that can treat multiple mental health problems at once. This new treatment is called Metacognitive Therapy (MCT).
The aim of the study is to see if participating in a randomized trial of Group MCT is a feasible and acceptable treatment for CYP suffering with anxiety, stress, depression, or a combination in comparison to usual care. This allows us to test key questions about recruitment and drop-out rates, test the protocol, and gain information about MCT including training and supervision needs of clinicians and the experience of patients receiving it.
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 (Investigator)
盲法说明
Chief investigator, research assistants and statisticians will be blind to treatment allocation of participants.
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seeking treatment for emotional disorder symptoms (i.e. generalized anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety and/or depression).
- •Native fluency in English language
- •Medication permitted but must be stabilised for 6 weeks.
排除标准
- •Presence of significant risk or safeguarding concerns
- •Head injury/organic impairment
- •Formal diagnosis or under assessment for Autism Spectrum Disorder or Attention Deficit-Hyperactivity Disorder
- •Eating Disorder
结局指标
主要结局
Revised Children Anxiety and Depression Scale - Short Version (RCADS)
时间窗: Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up
Youth self-report questionnaire measuring total anxiety, total depression and total anxiety and depression. This is a feasibility study and therefore it is not primarily powered to detect a difference (change in scores). The principal aim is to test the feasibility of a study using. Here we are testing the feasibility of using the measures (RCADS), therefore the measures will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Specifically, range in scores, number of complete measures, proportion of missing data. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment effects.
次要结局
- Metacognition Questionnaire - Adolescent Version (MCQ-A)(Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up)
- Strength and Difficulties Questionnaire (SDQ)(Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up)
- Child Health Utility - 9D (CHU-9D)(Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up)
- Mood & Feelings Questionnaire (MFQ)(Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up)
- Health and Social Case Service-Use Interview (SUI)(Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up)
研究者
Adrian Wells
Professor of Clinical and Experimental Psychopathology
University of Manchester