A Single-Blind Randomised Controlled Trial of Self-Help Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 242
- 试验地点
- 8
- 主要终点
- Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Depression and anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. Available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in cardiac rehabilitation services despite emphasis in key NHS policy.
Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention called metacognitive therapy (MCT) that reduces this style of thinking alleviates depression and anxiety in mental health settings.
This is a single-blind feasibility randomised controlled trial of metacognitive therapy delivered in a self-help format (Home-MCT). The aim of the study is to evaluate the acceptability and feasibility of integrating Home-MCT into cardiac rehabilitation services and to evaluate the effectiveness and cost-effectiveness of Home-MCT.
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
- Double (Investigator, Outcomes Assessor)
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
- •Patients who are referred to the CR pathway who meet Department of Health (DoH) and/or British Association for Cardiovascular Prevention and Rehabilitation (BACPR) CR eligibility criteria:
- •Acute coronary syndrome used for any condition brought on by sudden, reduced blood flow to the heart
- •Following revascularisation is the restoration of perfusion to a body part or organ that has suffered ischemia
- •Stable heart failure
- •Stable angina is chest pain or discomfort that most often occurs with activity or stress
- •Following implantation of cardioverter defibrillators/cardiac resynchronisation devices
- •Heart valve repair/replacement
- •Heart transplantation and ventricular assist devices
- •Adult congenital heart disease identified in adulthood
- •Other (atypical heart presentation: nausea, dizziness, lower chest discomfort, upper abdominal pressure or discomfort that feels like indigestion and upper back pain)
- •A score of ≥ 8 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scale
- •Minimum of 18 years old
- •Competent level of English language skills
排除标准
- •Cognitive impairment which precludes informed consent or ability to participate
- •Acute suicidality
- •Active psychotic disorders (i.e., two [or more] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms).
- •Current drug/alcohol abuse (A maladaptive pattern of drinking, leading to clinically significant impairment or distress)
- •Concurrent psychological intervention for emotional distress that is not part of usual care
- •Antidepressant or anxiolytic medications initiated in the previous 8 weeks
- •Life expectancy of less than 12 months
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline, 4 months follow up
The HADS is a 14-item self-report scale which evaluates symptoms of anxiety and depression. The HADS consists of two subscales: anxiety and depression. For each item a score is given between 0-3. Subscales scores are calculated by summing selected items on the questionnaire. Scores on each subscale range from 0-21. Scores between 0-7 are within the 'normal' range. Scores between 8- 10 are considered to be 'borderline' cases of psychological distress whilst scores of 11 or more are considered to be significant cases of psychological distress. Higher scores on the HADs indicate greater levels of anxiety or depression.
次要结局
- Metacognitions Questionnaire 30 (MCQ-30)(Baseline, 4 months follow up)
- Adherence questionnaire (regarding the Home-MCT intervention)(From the completion of the manual up to 4 months)
- Acceptability(From the completion of the manual till 4 months)
- Cognitive Attentional Syndrome Scale (CAS-1)(Baseline, 4 months follow up)
- Impact of Events Scale - Revised (IES-R)(Baseline, 4 months follow up)
- Health Related Quality of Life (EQ-5D-5L)(Baseline, 4 months follow up)
- Credibility questionnaire (regarding the Home-MCT intervention)(From the completion of the introduction of the Home-MCT manual up to 2 weeks)
- Economic Patient Questionnaire (EPQ)(Baseline, 4 months follow up)
研究者
Adrian Wells
Professor
University of Manchester