Stepped Care for Depression in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Self Care of Heart Failure Index (SCHFI) Maintenance Subscale
研究概览
简要总结
This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half of the participants will receive stepped care and half will receive usual care for depression; all participants will receive heart failure self-care education and support. The primary aims are to determine whether stepped care is superior to usual care for depression, and whether treating depression improves heart failure self-care outcomes.
详细描述
Depression is associated with poor heart failure self-care. Good self-care practices, including following dietary recommendations, taking prescribed medications, monitoring symptoms, and regular light exercise have been shown to improve quality of life and survival in persons with heart failure.
Both CBT and antidepressant medications have been used in previous studies to treat major depression in patients with heart failure. Participants in the intervention arm in this trial will start with CBT. Those who do not improve very much within the first 5-10 weeks of CBT may also be referred to their own physician to discuss antidepressant medications.
Heart failure self-care education and support will be provided after the first 8 weeks of the depression intervention. The study will determine whether people with heart failure benefit more from self-care education and support after their depression has been treated with a stepped care intervention, as compared to usual care for depression as provided by primary care providers.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable, clinically-documented New York Heart Association (NYHA) Class I-III heart failure.
- •Current major depressive episode.
- •Baseline Beck Depression Inventory (BDI-II) score 14 or greater
排除标准
- •Dementia or other significant cognitive or communication deficits
- •Terminal illness other than HF
- •Insurmountable logistical barriers to participation
- •Age less than 25 years
- •Current clinically significant substance abuse, bipolar disorder, schizophrenia, or other psychotic disorder
- •High risk of suicide
- •Current participation in non-study psychotherapy for depression or other psychiatric conditions
- •Initiation or modification of antidepressant medication treatment within past two months
- •Renal or hepatic conditions that would preclude the use of antidepressants.
结局指标
主要结局
Self Care of Heart Failure Index (SCHFI) Maintenance Subscale
时间窗: 16 weeks
The SCHFI Maintenance scale assesses self-reported heart failure self-care behaviors. The Maintenance score was the trial's primary self-care outcome measure. Scores range from 0 (worst) to 100 (best), with scores of 70 or higher consistent with adequate self-care.
Beck Depression Inventory (BDI-2) Total Score
时间窗: 16 weeks
The BDI-2 was used to assess the patient's self-reported severity of depression. Total scores can range from zero (best) to 63 (worst). Scores between 0-13 are considered to be in the nondepressed range; 14-19 are consistent with mild, 20-28 with moderate, and 29-63 with severe depression.
次要结局
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(16 weeks)
- Beck Anxiety Inventory(16 weeks)
- Hamilton Rating Scale for Depression (HAM-D-17)(16 weeks)
- Actigraphy(16 weeks)