A Feasibility Study on Integrating Home-based Metacognitive Therapy for Anxiety and Depression in the Cardiac Rehabilitation Pathway (PATHWAY STUDY WS3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Acceptability
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 home-based 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 provide provisional evidence of effectiveness and cost-effectiveness on 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
研究组 & 干预措施
Control
Participants allocated to the "control" group will receive treatment as usual for cardiac rehabilitation
Intervention
Participants allocated to the "intervention" group will receive treatment as usual for cardiac rehabilitation plus the home-based metacognitive therapy (Home-MCT)
干预措施: Home-based Metacognitive Therapy (Home-MCT) (Other)
结局指标
主要结局
Acceptability
时间窗: From the completion of the manual till 4 months
Acceptability of the intervention is defined as the completion of the first 4 modules of the Home-MCT manual, which includes 6 modules in total. Acceptability will be expressed as a % of all patients randomised to the treatment arm, minus deaths. This will be compared to the % of controls (minus deaths) who complete the 4-month follow up.
次要结局
- Cognitive Attentional Syndrome Scale (CAS-1)(Baseline, 4 months follow up, 12 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)
- Change in the Hospital Anxiety and Depression Scale (HADS)(Baseline, 4 months follow up, 12 months follow up)
- Adherence questionnaire (regarding the Home-MCT intervention)(From the completion of the manual up to 4 months)
- Metacognitions Questionnaire 30 (MCQ-30)(Baseline, 4 months follow up, 12 months follow up)
- Health Related Quality of Life (EQ-5D)(Baseline, 4 months follow up, 12 months follow up)
- Qualitative interviews with intervention patients to identify enablers and barriers to recruitment and engagement with the intervention (Home-MCT)(Up to 2 weeks before receiving the intervention and up to 1 month after the completion of the intervention)
- Impact of Events Scale - Revised (IES-R)(Baseline, 4 months follow up, 12 months follow up)
- Economic Patient Questionnaire (EPQ)(Baseline, 4 months follow up, 12 months follow up)
研究者
Adrian Wells
Professor
University of Manchester