Treatment of Functional Impairment in Patients With Heart Failure and Comorbid Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- BDI-II score at 6 months
研究概览
简要总结
The purpose of the study is to test whether Cognitive Behavior Therapy (CBT) plus heart failure self-care education is superior to "usual care" for depression.
详细描述
Comorbid depression is common in heart failure, but little is known about how to treat it. This randomized, controlled, efficacy trial will compare cognitive behavior therapy (CBT) to usual care (UC) for depression in heart failure. CBT will be integrated with an intervention to improve heart failure self-care, because depression and inadequate self-care are thought to be interrelated problems. It will also be integrated with clinical attention to primary caregiver stress. Basic heart failure education will be provided to all participants.
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 (Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New York Heart Association Class I, II, or III Heart Failure (Clinically diagnosed at least 3 months ago)
- •Meets the DSM-IV criteria for a current major depressive episode, or for current minor depression with a past history of at least one major depressive episode.
- •PHQ-9 score of 10 or greater plus 2 or 3 on question 1 or 2 over the last 2 weeks including today
排除标准
- •Less than 30 years old
- •Current ETOH / drug abuse
- •Bipolar disorder, schizophrenia, or other psychotic disorder
- •Communication barrier
- •Currently in competing research protocol
- •High risk for suicide
- •Insurmountable logistical barriers to laboratory assessment visits
- •Major mobility-limiting physical disability
- •Poor 1 year prognosis not r/t heart failure
- •Hospitalized for heart failure or acute coronary syndrome in last month
- •Initiated antidepressant therapy in the past 4 weeks
- •Current non-study psychotherapy for depression or other psychiatric problem
结局指标
主要结局
BDI-II score at 6 months
时间窗: Baseline, 3 months, 6 months, 9 months , 12 months
次要结局
- Self-care of Heart Failure Index(Baseline, 3 months, 6 months, 9 months, 12 months)
- Beck Anxiety Inventory(Baseline, 3 months, 6 months, 9 months, 12 months)
- Medical outcomes study SF-12(Baseline, 3 months, 6 months, 9 months, 12 months)
- PROMIS Physical Functioning Scale(Baseline, 6 months)
- Kansas City Cardiomyopathy Questionnaires(Baseline, 3 months, 6 months, 9 months, 12 months)
- 6 Minute Walk Test(Baseline, 6 months)
- Depression Interview and Structured Hamilton (DISH)(Baseline, 6 months)