认知疗法联合抗抑郁药与单纯抗抑郁药治疗对重性抑郁障碍康复率的影响：一项随机临床试验。
Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial.
机构信息
Department of Psychology, Vanderbilt University, Nashville, Tennessee.
Department of Psychology, University of Pennsylvania, Philadelphia.
出版信息
JAMA Psychiatry. 2014 Oct;71(10):1157-64. doi: 10.1001/jamapsychiatry.2014.1054.
IMPORTANCE
Antidepressant medication (ADM) is efficacious in the treatment of depression, but not all patients achieve remission and fewer still achieve recovery with ADM alone.
OBJECTIVE
To determine the effects of combining cognitive therapy (CT) with ADM vs ADM alone on remission and recovery in major depressive disorder (MDD).
DESIGN, SETTING, AND PARTICIPANTS: A total of 452 adult outpatients with chronic or recurrent MDD participated in a trial conducted in research clinics at 3 university medical centers in the United States. The patients were randomly assigned to ADM treatment alone or CT combined with ADM treatment. Treatment was continued for up to 42 months until recovery was achieved.
INTERVENTIONS
Antidepressant medication with or without CT.
MAIN OUTCOMES AND MEASURES
Blind evaluations of recovery with a modified version of the 17-item Hamilton Rating Scale for Depression and the Longitudinal Interval Follow-up Evaluation.
RESULTS
Combined treatment enhanced the rate of recovery vs treatment with ADM alone (72.6% vs 62.5%; t451 = 2.45; P = .01; hazard ratio [HR], 1.33; 95% CI, 1.06-1.68; number needed to treat [NNT], 10; 95% CI, 5-72). This effect was conditioned on interactions with severity (t451 = 1.97; P = .05; NNT, 5) and chronicity (χ2 = 7.46; P = .02; NNT, 6) such that the advantage for combined treatment was limited to patients with severe, nonchronic MDD (81.3% vs 51.7%; n = 146; t145 = 3.96; P = .001; HR, 2.34; 95% CI, 1.54-3.57; NNT, 3; 95% CI, 2-5). Fewer patients dropped out of combined treatment vs ADM treatment alone (18.9% vs 26.8%; t451 = -2.04; P = .04; HR, 0.66; 95% CI, 0.45-0.98). Remission rates did not differ significantly either as a main effect of treatment or as an interaction with severity or chronicity. Patients with comorbid Axis II disorders took longer to recover than did patients without comorbid Axis II disorders regardless of the condition (P = .01). Patients who received combined treatment reported fewer serious adverse events than did patients who received ADMs alone (49 vs 71; P = .02), largely because they experienced less time in an MDD episode.
CONCLUSIONS AND RELEVANCE
Cognitive therapy combined with ADM treatment enhances the rates of recovery from MDD relative to ADMs alone, with the effect limited to patients with severe, nonchronic depression.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00057577.
重要性：抗抑郁药物（ADM）在治疗抑郁症方面是有效的，但并非所有患者都能达到缓解，更少有患者能仅通过 ADM 达到康复。
目的：确定认知疗法（CT）与 ADM 联合应用与 ADM 单独治疗在重度抑郁症（MDD）患者中的缓解和康复效果。
设计、环境和参与者：共有 452 名患有慢性或复发性 MDD 的成年门诊患者参与了在美国 3 所大学医疗中心的研究诊所进行的一项试验。患者被随机分配至 ADM 单独治疗或 CT 联合 ADM 治疗。治疗持续长达 42 个月，直到达到康复。
干预措施：ADM 治疗加或不加 CT。
主要观察结果和测量：使用改良的 17 项汉密尔顿抑郁量表（Hamilton Rating Scale for Depression）和纵向间隔随访评估（Longitudinal Interval Follow-up Evaluation）对康复进行盲法评估。
结果：与 ADM 单独治疗相比，联合治疗提高了康复率（72.6% vs 62.5%；t451=2.45；P=.01；风险比[HR]，1.33；95%CI，1.06-1.68；需要治疗的人数[NNT]，10；95%CI，5-72）。这种效果与严重程度（t451=1.97；P=.05；NNT，5）和慢性程度（χ2=7.46；P=.02；NNT，6）存在交互作用，因此联合治疗的优势仅限于严重、非慢性 MDD 患者（81.3% vs 51.7%；n=146；t145=3.96；P=.001；HR，2.34；95%CI，1.54-3.57；NNT，3；95%CI，2-5）。与 ADM 单独治疗相比，联合治疗的患者退出治疗的人数更少（18.9% vs 26.8%；t451=-2.04；P=.04；HR，0.66；95%CI，0.45-0.98）。无论是作为治疗的主要效果还是与严重程度或慢性程度的交互作用，缓解率均无显著差异。无论病情如何，合并轴 II 障碍的患者康复时间都比没有合并轴 II 障碍的患者长（P=.01）。与接受 ADM 单独治疗的患者相比，接受联合治疗的患者报告的严重不良事件更少（49 例 vs 71 例；P=.02），这主要是因为他们在 MDD 发作期间的时间较少。
结论和相关性：与 ADM 单独治疗相比，认知疗法联合 ADM 治疗可提高 MDD 的康复率，其效果仅限于严重、非慢性抑郁症患者。
试验注册：clinicaltrials.gov 标识符：NCT00057577。
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