The ACTonHEART Study: a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy in Cardiac Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Low-density lipoprotein (LDL)cholesterol
研究概览
简要总结
The study will determine whether a brief intervention program based on Acceptance and Commitment Therapy can be effective for the reduction of modifiable risk factors and improvement of psychological well-being in patients referred to cardiac rehabilitation
详细描述
The Acceptance and Commitment Therapy is a mindfulness-based intervention which efficacy has been proven in the treatment of depression and anxiety, in stress reduction and in the modification of health- related behaviors in patients with several physical conditions. The application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour.
The purpose of the trial is to evaluate the efficacy of a brief group-administered program based on Acceptance and Commitment Therapy in improving patients' ability to address modifiable multiple cardiovascular risk factors and overall psychological well-being, compared with the usual care.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having a current diagnosis of ischemic heart disease (IHD)
- •being affected by major modifiable cardiovascular risk factors that will be assessed through the INTERHEART Modifiable Risk Score.
- •Only subjects with a full score >9 will be included in the study.
- •between the ages of 18 and 70 years
- •fluency in spoken and written Italian language
- •expression of written informed consent.
排除标准
- •cognitive impairment
- •severe psychiatric disorders according to Diagnostic and Statistical Manual-IV TR criteria (APA, 2000).
研究组 & 干预措施
ACT-based intervention
The ACT-based intervention integrates educational topics on heart healthy behaviours with mindfulness and acceptance training regarding difficult thoughts and feelings, clarification of health-related values and commitment to behave in the valued direction while contacting difficult experiences.
干预措施: ACT-based intervention (Behavioral)
Usual care
Usual care is based on current guidelines for the long-term multi-disciplinary rehabilitation and prevention of cardiac patients.
干预措施: usual care (Behavioral)
ACT-based intervention
The ACT-based intervention integrates educational topics on heart healthy behaviours with mindfulness and acceptance training regarding difficult thoughts and feelings, clarification of health-related values and commitment to behave in the valued direction while contacting difficult experiences.
干预措施: usual care (Behavioral)
结局指标
主要结局
Low-density lipoprotein (LDL)cholesterol
时间窗: Baseline and 12 months
Change from baseline LDL cholesterol level
Blood pressure
时间窗: baseline and 12 months
Change from baseline resting blood pressure (the mean of 2 measures taken 2 minutes apart with a manual sphygmomanometer)
Body Mass Index
时间窗: baseline and 12 months
Change from baseline Body Mass Index. It is calculated as weight in kilograms divided by height in meters squared
Psychological Well-Being
时间窗: Baseline and 12 months
Change from baseline Psychological Well-Being. It will be measured by the Psychological General Well-Being Inventory. The PGWBI is a self-administered questionnaire composed by six sub-scales: anxiety, depression, positive well-being, self-control, general health and vitality. Higher scores indicate better health.
次要结局
- Physical activity(Baseline anf 12 months)
- Smoking cessation(At 1-year follow-up)
- Adherence to medication(Baseline and 12 months)
- Exercise capability(Baseline and 12 months)
- Dietary habits(Baseline and 12 months)
- Health-related quality of life(Baseline and 12 months)