Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Changes in The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score between groups over time
研究概览
简要总结
A Study to evaluate the efficacy of psychotherapy for easing the cardiac symptoms and improving and quality of life in patients with hypertrophic cardiomyopathy accompanied with depression
详细描述
This study will use a 8 week parallel group design. 100 patients diagnosed as hypertrophic cardiomyopathy accompanied with depression will be into experimental group and control group. The experimental group received 8 times of psychological treatments for once each week; the control group did not receive any antidepressant treatment. Follow-up assessments will be performed at baseline, week 4 and 8.
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
- None
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
- •Diagnosed as hypertrophic cardiomyopathy;
- •Diagnosed as depression;
排除标准
- •Patients with left ventricular ejection fraction (EF) ≦ 30%;
- •Renal dysfunction with serum creatinine ≧451umol/l;
- •Severe heart failure and New York Heart Association (NYHA) Heart Failure Grade III;
- •Combine with any type of malignant tumor;
- •Combine with other serious mental illnesses such as bipolar disorder, schizophrenia, schizophrenia-like illness, severe dementia, etc.;
- •Have received medication of antidepressant or psychotherapy;
- •Patients with major depression; Patients with a serious risk of suicide or have had suicide attempts;
- •Pregnant women and lactating women, or women who are planning to become pregnant or breastfeeding during the study period;
- •Other circumstances in which the researcher judges that it is not suitable as a research object.
研究组 & 干预措施
Experimental Arm
Participants will receive psychotherapy for once a week.
干预措施: Psychotherapy (Other)
Control Arm
Participants will not receive any treatment for depression.
结局指标
主要结局
Changes in The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score between groups over time
时间窗: Baseline, week 2, 4, 8
The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) tests the quality of life and gives emphasis to the subjective perspective of patients on physical, psychological and social domains.
次要结局
- Changes in Generalized Anxiety Disorder (GAD) -7(Baseline, week 2, 4, 8)
- Changes in The Hamilton Rating Scale for Anxiety (HAM-A)(Baseline, week 2, 4, 8)
- Changes in frequency of Arrhythmia(Baseline, week 2, 4, 8)
- Changes in The Hamilton Depression Rating Scale17 (HAM-D17) score(Baseline, week 2, 4, 8)
- Changes in frequency of Syncope(Baseline, week 2, 4, 8)
- Changes in Patient Health Questionnaire (PHQ) -9(Baseline, week 2, 4, 8)