Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in the Cardiac Rehabilitation Pathway: A Single-blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 10
- 主要终点
- Change in Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Cardiac rehabilitation (CR) services aim to improve heart disease patients' health and quality of life, and reduce the risk of further cardiac events. Depression and anxiety (distress) are common among CR patients: 37% of patents have significant anxiety and/or depressive symptoms. Distressed patients are at greater risk of death, further cardiac events and poorer quality of life than those without distress and they use more healthcare. Available drug and psychological treatments have only small effects on distress and quality of life, and no effects on physical health. Therefore, it is essential that more effective treatments for depression and anxiety are integrated into CR services. Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention (metacognitive therapy) that reduces this style of thinking alleviates depression and anxiety in mental health settings. The investigators aim to conduct a pilot trial of the group intervention and in work stream 2 the investigators will undertake a full-scale trial to evaluate whether adding the group intervention to standard CR is more effective at alleviating anxiety and depression than standard CR alone.
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)
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
- •Heart disease patients referred to CR with: Acute coronary syndrome
- •Following revascularisation; stable heart failure
- •Stable angina, implanted cardioverter defibrillators
- •Heart valve repair/replacement
- •Heart transplantation and ventricular assist devices
- •Adult congenital heart disease
- •Must have a score of 8 or more on either the depression or anxiety subscale of the HADS
- •Competent level of English language skills
排除标准
- •Cognitive impairment which precludes informed consent/ability to participate
- •Acute suicidality
- •Active psychotic disorders
- •Current drug/alcohol abuse
- •Concurrent psychological intervention for emotional distress
- •Antidepressant or anxiolytic medication initiated in previous 8 weeks
- •Life expectancy of less than 12 months
结局指标
主要结局
Change in Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline pre treatment, four-month post baseline
次要结局
- Health Related Quality of Life (EQ-5D)(Baseline, four-month post baseline, 12 months follow-up)
- Hospital Anxiety and Depression Scale(12 month follow-up)
- Impact of Events Scale -revised(Baseline, four-month post baseline, 12 months follow-up)
- Cognitive Attentional Syndrome scale (CAS-1)(Baseline, four-month post baseline, 12 months follow-up)
- Economic Patient Questionnaire(Baseline, 4 month follow-up, 12 months follow-up)
- Metacognitions Questionnaire 30(Baseline, four-month post baseline, 12 month follow-up)
研究者
Adrian Wells
Professor of Clinical and Experimental Psychopathology
University of Manchester
