Testing a Brief Cognitive Therapy Intervention for Depressive Symptoms in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Cardiac event-free survival
研究概览
简要总结
Heart failure (HF) affects 5 million people in the US and is the most common cause of hospitalization in elderly adults. One-third of patients who are hospitalized with HF have major depression. Depressed HF patients have double the rates of morbidity and/or mortality and worse health-related quality of life than non-depressed HF patients. The investigators previous pilot research suggests that a brief Cognitive Therapy (CT) intervention may improve short-term cardiac survival among depressed hospitalized HF patients compared to non-depressed HF patients who received usual care. Therefore, the investigators will conduct a larger study to evaluate the effects of the intervention on longer cardiac event-free survival, symptoms of depression, health-related quality of life, and stress levels in patients with HF. The investigators hypothesize that patients in the intervention group will experience longer cardiac event-free survival, lower levels of depressive symptom, better health-related quality of life, and lower salivary cortisol levels at follow-up than patients who receive 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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the hospital with a primary or secondary diagnosis of congestive heart failure OR admitted to the hospital for cardiac reasons and has a history of chronic heart failure
- •American College of Cardiology/ American Heart Association Stage C HF
- •21 years or older
排除标准
- •Co-existing terminal illness likely to be fatal within the next 12 months
- •End-stage HF (defined as American College of Cardiology Stage D HF)
- •Cognitive impairment that precludes the ability to give informed consent
- •Active suicidality (defined choosing option 1, 2 or 3 on Item 9 of the PHQ-9)
- •History of the death of a spouse or child within the past month
- •History of psychotic illness or bipolar illness
- •Current alcohol dependence or other substance abuse
- •Non-English speaking or possessing any other communication barrier
研究组 & 干预措施
Usual Care
干预措施: Brief Cognitive Therapy Intervention (Behavioral)
结局指标
主要结局
Cardiac event-free survival
时间窗: Three months to five years
To compare cardiac event-free survival at 3 months, 6 months, and up to five years between patients with HF and depressive symptoms who receive a brief cognitive therapy intervention (depressive symptom intervention group) and patients with HF and depressive symptoms who receive usual care (depressive symptom usual care group).
次要结局
- Salivary cortisol(1 week, 3 months, and 6 months)
- No depressive symptom comparison group(1 week, 3 months, and 6 months)
- Depressive symptoms(1 week, 3 months, and 6 months)
- Salivary vs. serum biomarkers(Baseline)
- Health-related quality of life(1 week, 3 months, and 6 months)
研究者
Rebecca L. Dekker, PhD, RN, APRN
Principal Investigator
University of Kentucky