Effect of Psycho-behavioral Intervention on the Depression, Cardiac Function and Quality of Life in Older Adults With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 236
- 试验地点
- 6
- 主要终点
- 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
研究概览
简要总结
The study aims to explore the effectiveness of psycho-behavioral intervention on depressive symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac function and quality of life will also be explored.
详细描述
Depression has been one of the emerging health concerns for older adults, especially for those with chronic heart failure (CHF). It was about 4-5 times more prevalent among patients with CHF than healthy population and independently associated with poor outcome of CHF. As suggested in the clinical management guideline of CHF, it is imperative to create integrative intervention for older adults with CHF, including timely detection and intervention, and ultimately improving the clinical outcome of CHF. However, the approach appropriate for depression intervention among Chinese older adults has yet been developed. This study aims to explore the effectiveness of psycho-behavioral intervention on depression associated with chronic heart failure in old age.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 60 -85 years old.
- •male or female.
- •Diagnosis with depression as measured with PHQ-9 score of 5 and greater;
- •The subject is diagnosed with chronic heart failure according to their history, symptoms, signs, and adjuvant examinations (eg,echocardiography), in line with the diagnostic criteria for chronic heart failure presented in the China Heart Failure Diagnosis and Treatment Guidelines, with NYHA (New York Heart Association) grade II-III.
- •Reading and writing competency for completing the rating scales.
- •Sufficient physical condition, hearing and vision to ensure the completion of psychological behavior intervention.
排除标准
- •Currently taking antidepressant drugs, and drug dose is unstable.
- •With is a serious risk of suicide, suicide attempts and suicidal behavior (HAMD17 score of 30 or above, or suicide subscale score of 3 and above，or suicide subscale score of MINI of 6 or above).
- •Intact cognitive function with CSI-D score of less than
- •Having other major mental disorders, including Alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse
- •Planned heart surgery within 9 months.
- •Unable to comply with psychological intervention due to serious physical conditions -
结局指标
主要结局
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
时间窗: between baseline and week 12
The primary outcome measure is the response rate of depression from baseline to week 12. The response rate was defined as a 50% or greater score reduction on 16 Item Quick Inventory of Depressive Symptomatology-Self-Report. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms.
次要结局
- Geriatric Depression Inventory-Self-Report(between baseline and week 4, 8, 12, 24 and 36)
- cardiac function(between baseline and week 12, and between baseline and week 36)
- Minnesota living with heart failure questionnaire(between baseline and week 4, 8, 12, 24 and 36)
- 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version(between baseline and week 1, 2, 4, 8, 24 and 36)
- 17-Item Hamilton Rating Scale for Depression(between baseline and week 4, 8, 12, 24 and 36)
- Beck Depression Inventory II(between baseline and week 1, 2, 4, 8, 12, 24 and 36)
- amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)(between baseline and week 12, and between baseline and week 36)
研究者
Huali Wang
Principal Investigator
Peking University