Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- BDI-II
研究概览
简要总结
This study will determine whether the psychological and physical benefits of expressive writing extend to obese in-patients with Ischemic Heart Disease (IHD)referred to cardiac rehabilitation
详细描述
Expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve both physical and psychological health based on health outcome measures such as number of doctor's visits and hospital days, blood pressure control, lung and immune function, pain, anxiety and depression. Given its simplicity and obvious advantages in terms of cost-effectiveness, expressive writing has great potential as a therapeutic tool or as a means of self-help, either alone or as an adjunct to traditional therapies. This modality has not been studied in obese patients with Ischemic Heart Disease.
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 (Participant)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic Heart disease
- •Signed informed consent
排除标准
- •Visual or manual limitations that preclude reading and writing
- •Unwilling to participate
研究组 & 干预措施
Disease-related expressive writing
Participants in the disease-related expressive writing condition write about their feelings about cardiac disease four times, for at least 20 minutes each time, during a two week period
干预措施: Disease-related Expressive writing (Behavioral)
Traditional expressive writing
Participants in the traditional expressive writing condition write about their feelings about one or more stressful experiences they lived in the past, for at least 20 minutes each time, during a two week period
干预措施: Active Comparator: Traditional expressive writing (Behavioral)
Neutral writing
Participants in the neutral writing condition write about the facts about cardiac disease, for at least 20 minutes each time, during a two week period
干预措施: Sham Comparator: Neutral writing (Behavioral)
Control condition
Participants in the control condition do not receive any intervention and complete only the assessments
结局指标
主要结局
BDI-II
时间窗: 1 year
The Beck Depression Inventory is a measure of depressive symptoms
BDI
时间窗: 1 year
The Beck Anxiety Inventory is a measure of cognitive and somatic symptoms of anxiety
Brief-PTGI
时间窗: 1 year
The Brief Post-Traumatic Growth Inventory is a measure of positive growth following adversity
SF12
时间窗: 1 year
The SF12 is a generic measure of both physical and emotional components of health-related quality of life
次要结局
- BMI(1 year)
- METs(1 year)
- Multiple Coronary Risk Factors(1 year)
研究者
Gianluca Castelnuovo
Professor
Istituto Auxologico Italiano