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临床试验/NCT02420431
NCT02420431已完成不适用

Improving the Effectiveness of Psychological Interventions for Depression and Anxiety in the Cardiac Rehabilitation Pathway: A Single-blind Randomised Controlled Trial

University of Manchester10 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2015年7月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Wells

Professor of Clinical and Experimental Psychopathology

University of Manchester

研究点 (10)

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