Mindfulness Based Intervention in Patients With Persistent Pain in Chest (MIPIC) of Non-Cardiac Cause - a Feasibility Randomised Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Compliance with mindfulness-based behavior therapy
研究概览
简要总结
Non-cardiac chest pain (NCCP) is a common symptom in clinical practice with no satisfactory treatment. We plan to perform a feasibility randomized controlled trial (RCT) to explore the role of mindfulness therapy in patients with NCCP to ascertain the number of patients who would be willing to enroll and complete the mindfulness intervention. This will allow us to develop and refine the adaption of mindfulness therapy as well as assess the compliance.
详细描述
Chest pain is a common condition in primary care with the lifetime prevalence of no cardiac cause (NCCP) being 20-33 percent compared to 6-7 percent for cardiac chest pain. The latter patients obtain appropriate medical and interventional treatment but those with NCCP are often left with persistent symptoms, psychological distress, impaired quality of life, high unemployment, work absenteeism, and high use of healthcare resources. They are often treated with analgesics, proton-pump inhibitors, anxiolytics, but generally with little benefit.
Mindfulness has grown in popularity in the last 2-3 decades as an accepted form of behavior therapy for the treatment of stress and depression. Several RCTs have been performed in patients with chronic pain, but none specific to chest pain. They have been heterogeneous in nature with low-quality evidence for improvement of pain with mindfulness. There is thus a requirement for larger, well-designed and rigorous RCTs in patients with chronic pain, including those with NCCP.
With this feasibility RCT study, the investigators would like to obtain more information about some uncertainties that would allow them to conduct a larger, well-designed RCT. The investigators plan to recruit 50 participants from all those who have attended the chest pain clinic in the previous 12-months and randomize them in a simple 1:1 manner into receiving Mindfulness-based Cognitive Therapy (MBCT) therapy (intervention arm) or usual treatment by their general practitioner (control arm). The participants will undergo a basic clinical assessment with symptoms, heart-rate, blood pressure, height, body weight, cardiovascular risk factors. They will be required to complete different questionnaires to assess their chest pain limitation and frequency, general and cardiac-specific anxiety, mindfulness, quality of life, and health-related resource utilization at baseline and after completion of MBCT or usual treatment.
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 (Outcomes Assessor)
盲法说明
The research staff conducting the outcome follow-up will be blinded to the randomization.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Attendance to the chest pain clinic within the last 12 months and no cardiac cause for chest pain were identified.
- •Have persistent chest pain symptoms on or after usual treatment
- •Ability to carry out the 8-week mindfulness course and required home practice.
- •Able to understand verbal and written English.
排除标准
- •Acute presentation with ECG changes and/ or raised enzymes at any time prior to enrolment.
- •Known history of coronary artery disease.
- •Under active psychiatric care or waiting for a psychological assessment or have received a prescription of a new psychoactive drug within the previous 3 months.
- •Undergoing any other form of counselling or behaviour therapy.
结局指标
主要结局
Compliance with mindfulness-based behavior therapy
时间窗: 8 months
To assess compliance with the mindfulness program by participation in the 8-week sessions and home practice. Each participant will be given a worksheet to complete for home practice and their experience.
Willingness to participate in mindfulness-based behaviour therapy
时间窗: 8 months
To assess the number of patients with persistent chest pain without a heart condition who would be willing (and consent) to participate in mindfulness-based behaviour therapy
次要结局
- Prevalence of cardiac anxiety(8 months)
- State of mindfulness(8-months)
- Persistent chest pain(8-months)
- Prevalence of general anxiety and depression(8- months)
- Health resource utilization(8-months)
- Generic health related quality of life(8-months)