Freedland Kenneth E, Carney Robert M, Rich Michael W, Steinmeyer Brian C, Rubin Eugene H
Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.
Department of Medicine, Washington University School of Medicine, St Louis, Missouri.
JAMA Intern Med. 2015 Nov;175(11):1773-82. doi: 10.1001/jamainternmed.2015.5220.
Depression and inadequate self-care are common and interrelated problems that increase the risks of hospitalization and mortality in patients with heart failure (HF).
To determine the efficacy of an integrative cognitive behavior therapy (CBT) intervention for depression and HF self-care.
DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial with single-blind outcome assessments. Eligible patients were enrolled at Washington University Medical Center in St Louis between January 4, 2010, and June 28, 2013. The primary data analyses were conducted in February 2015. The participants were 158 outpatients in New York Heart Association Class I, II, and III heart failure with comorbid major depression.
Cognitive behavior therapy delivered by experienced therapists plus usual care (UC), or UC alone. Usual care was enhanced in both groups with a structured HF education program delivered by a cardiac nurse.
The primary outcome was severity of depression at 6 months as measured by the Beck Depression Inventory. The Self-Care of Heart Failure Index Confidence and Maintenance subscales were coprimary outcomes. Secondary outcomes included measures of anxiety, depression, physical functioning, fatigue, social roles and activities, and quality of life. Hospitalizations and deaths were exploratory outcomes.
One hundred fifty-eight patients were randomized to UC (n = 79) or CBT (n = 79). Within each arm, 26 (33%) of the patients were taking an antidepressant at baseline. One hundred thirty-two (84%) of the participants completed the 6-month posttreatment assessments; 60 (76%) of the UC and 58 (73%) of the CBT participants completed every follow-up assessment (P = .88). Six-month depression scores were lower in the CBT than the UC arm on the Beck Depression Inventory (BDI-II) (12.8 [10.6] vs 17.3 [10.7]; P = .008). Remission rates differed on the BDI-II (46% vs 19%; number needed to treat [NNT] = 3.76; 95% CI, 3.62-3.90; P < .001) and the Hamilton Depression Scale (51% vs 20%; NNT = 3.29; 95% CI, 3.15-3.43; P < .001). The groups did not differ on the Self-Care Maintenance or Confidence subscales. The mean (SD) Beck Depression Inventory scores 6 months after randomization were lower in the CBT (12.8 [10.6]) than the UC arm (17.3 [10.7]), P = .008. There were no statistically significant differences between the groups on the Self-Care Maintenance or Confidence subscale scores or on physical functioning measures. Anxiety and fatigue scores were lower and mental- and HF-related quality of life and social functioning scores were higher at 6 months in the CBT than the UC arm, and there were fewer hospitalizations in the intervention than the UC arm.
A CBT intervention that targets both depression and heart failure self-care is effective for depression but not for HF self-care or physical functioning relative to enhanced UC. Additional benefits include reduced anxiety and fatigue, improved social functioning, and better health-related quality of life.
clinicaltrials.gov Identifier: NCT01028625.
抑郁症和自我护理不足是常见且相互关联的问题，会增加心力衰竭（HF）患者的住院和死亡风险。
确定综合认知行为疗法（CBT）干预对抑郁症和心力衰竭自我护理的疗效。
设计、设置和参与者：采用单盲结果评估的随机临床试验。符合条件的患者于2010年1月4日至2013年6月28日在圣路易斯的华盛顿大学医学中心入组。主要数据分析于2015年2月进行。参与者为158名纽约心脏病协会I、II和III级心力衰竭合并重度抑郁症的门诊患者。
由经验丰富的治疗师提供认知行为疗法加常规护理（UC），或仅采用常规护理。两组均通过心脏护士提供的结构化心力衰竭教育计划加强常规护理。
主要结局是6个月时用贝克抑郁量表测量的抑郁严重程度。心力衰竭自我护理指数信心和维持子量表为共同主要结局。次要结局包括焦虑、抑郁、身体功能、疲劳、社会角色和活动以及生活质量的测量指标。住院和死亡情况为探索性结局。
158名患者被随机分为常规护理组（n = 79）或认知行为疗法组（n = 79）。在每组中，26名（33%）患者在基线时正在服用抗抑郁药。132名（84%）参与者完成了6个月的治疗后评估；常规护理组60名（76%）和认知行为疗法组58名（73%）参与者完成了每次随访评估（P = 0.88）。在贝克抑郁量表（BDI-II）上，认知行为疗法组6个月时的抑郁评分低于常规护理组（12.8 [10.6] 对17.3 [10.7]；P = 0.008）。BDI-II上的缓解率有所不同（46% 对19%；治疗所需人数 [NNT] = 3.76；95% CI，3.62 - 3.90；P < 0.001）以及汉密尔顿抑郁量表（51% 对20%；NNT = 3.29；95% CI，3.15 - 3.43；P < 0.001）。两组在自我护理维持或信心子量表上没有差异。随机分组后6个月时，认知行为疗法组贝克抑郁量表平均（标准差）评分（12.8 [10.6]）低于常规护理组（17.3 [10.7]），P = 0.008。两组在自我护理维持或信心子量表评分或身体功能测量指标上没有统计学显著差异。在6个月时，认知行为疗法组的焦虑和疲劳评分较低，与心理和心力衰竭相关的生活质量及社会功能评分较高，且干预组的住院次数少于常规护理组。
针对抑郁症和心力衰竭自我护理的认知行为疗法干预对抑郁症有效，但相对于强化常规护理，对心力衰竭自我护理或身体功能无效。其他益处包括焦虑和疲劳减轻、社会功能改善以及与健康相关的生活质量提高。
clinicaltrials.gov标识符：NCT01028625。
