An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer (OMAC Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression Scale (HADS-Total)
研究概览
简要总结
Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors require treatment for clinical levels of emotional distress. The investigators will conduct a phase I open trial to test the potential efficacy of MCT in cancer survivors.
详细描述
Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors require treatment for clinical levels of emotional distress. There is scope for improvements in the efficacy of current pharmacological and psychological interventions. Reflecting this limited efficacy in the face of the need for psychological treatment, the National Cancer Survivorship Research Initiative highlighted development and evaluation of practically feasible interventions for depression and anxiety in cancer survivors as an urgent research priority. It is recognised that current influential psychotherapeutic approaches need to be modified to meet the specific needs associated with cancer. However modifications have been pragmatic rather than theory-driven and have not improved efficacy.
This study addresses the stages of 'development' and 'piloting and feasibility' in intervention development, albeit with a relatively well-defined starting point given existing evidence for efficacy of MCT in other settings and promising preliminary evidence of applicability in cancer. The investigators will conduct a phase I open trial to test the potential efficacy of MCT in cancer survivors.
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
- •Cancer diagnosis at least 6 months previously
- •Scoring >15 on the Hospital Anxiety and Depression Scale Total
- •Stable on, or free from, psychotropic medication
排除标准
- •History of psychotic disorder, learning disability, or organic mental disorder
- •Risk of self-harm or suicide warranting immediate intervention
- •In palliative phase of treatment
- •Being considered for risk-reducing or reconstructive surgery within 1 year
- •Concurrent psychological treatment
- •Cognitive impairment precluding informed consent or participation
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS-Total)
时间窗: Change in HADS total following the course of the six week intervention and over the six month follow-up
A general measure of anxiety and depression used in people
次要结局
未报告次要终点
研究者
Peter Fisher
Dr
University of Liverpool
