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预防单独使用抗抑郁药物或联合认知行为疗法从重度抑郁发作中康复后的复发:一项 2 期随机临床试验的第 2 阶段。

Prevention of Recurrence After Recovery From a Major Depressive Episode With Antidepressant Medication Alone or in Combination With Cognitive Behavioral Therapy: Phase 2 of a 2-Phase Randomized Clinical Trial.

机构信息

Department of Psychology, University of Pennsylvania, Philadelphia.

Department of Psychiatry, Rush University, Chicago, Illinois.

出版信息

JAMA Psychiatry. 2020 Mar 1;77(3):237-245. doi: 10.1001/jamapsychiatry.2019.3900.

DOI:10.1001/jamapsychiatry.2019.3900
PMID:31799993
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6902236/
Abstract

IMPORTANCE

Antidepressant medication (ADM) maintenance treatment is associated with the prevention of depressive recurrence in patients with major depressive disorder (MDD), but whether cognitive behavioral therapy (CBT) treatment is associated with recurrence prevention remains unclear.

OBJECTIVE

To determine the effects of combining CBT with ADM on the prevention of depressive recurrence when ADMs are withdrawn or maintained after recovery in patients with MDD.

DESIGN, SETTING, AND PARTICIPANTS: A total of 292 adult outpatients with chronic or recurrent MDD who participated in the second phase of a 2-phase trial. Participants had recovered in the first phase of the trial receiving ADM, either alone or in combination with CBT. The trial was conducted in research clinics in 3 university medical centers in the United States. Patients in phase 2 were randomized to receive maintenance of or withdrawal from ADM and were followed up for 3 years. The first and last patients entered phase 2 in August 2003 and October 2009, respectively. The last patient completed phase 2 in August 2012. Data were analyzed from December 2013 to December 2018.

INTERVENTIONS

Maintenance of or withdrawal from treatment with ADM.

MAIN OUTCOMES AND MEASURES

Recurrence of an MDD episode using longitudinal interval follow-up evaluations; sustained recovery across both phases.

RESULTS

A total of 292 participants (171 women, 121 men; mean [SD] age 45.1 [12.9] years) were included in analyses of depressive recurrence. Maintenance ADM yielded lower rates of recurrence compared with ADM withdrawal regardless of whether patients had achieved recovery in phase 1 with ADM alone (48.5% vs 74.8%; z = -3.16; P = .002; number needed to treat [NNT], 2.8; 95% CI, 1.8-7.0) or ADM plus CBT (48.5% vs 76.7%; z = -3.49; P < .001; NNT, 2.7; 95% CI, 1.9-5.9). Sustained recovery rates differed as a function of phase 2 condition, with maintenance ADM superior to ADM withdrawal (z = 2.90; P = .004; OR, 2.54; 95% CI, 1.37-4.84; NNT, 2.3; 95% CI, 1.5-6.4). Phase 1 condition was not associated with differential rates of sustained recovery (ADM alone vs ADM plus CBT; z = 0.22; P = .83; OR, 1.08; 95% CI, 0.52-2.11; NNT, 26.0; 95% CI, number needed to harm 3.2 to NNT 2.8), nor was there a significant interaction of phase 1 condition and phase 2 condition (z = 0.30; P = .77; OR, 1.14; 95% CI, 0.49-2.88).

CONCLUSIONS AND RELEVANCE

Maintenance ADM treatment, but not previous exposure to CBT, was associated with reduced rates of depressive recurrence. In previous studies, when CBT has been provided without ADM, CBT has shown a preventive effect on depressive relapse. Whether CBT also has a preventive effect on depressive recurrence, or if adding ADM interferes with any such preventive effect, remains unclear.

TRIAL REGISTRATION

ClinicalTrial.gov identifier: NCT00057577.

摘要

重要性:抗抑郁药物(ADM)维持治疗与预防重度抑郁症(MDD)患者的抑郁复发有关,但认知行为疗法(CBT)治疗是否与预防复发有关尚不清楚。

目的:确定 CBT 联合 ADM 在 MDD 患者康复后停用或维持 ADM 时对预防抑郁复发的影响。

设计、地点和参与者:总共 292 名患有慢性或复发性 MDD 的成年门诊患者参加了一项 2 期试验的第 2 阶段。参与者在第一阶段接受 ADM 单独或联合 CBT 治疗后已康复。该试验在美国 3 家大学医学中心的研究诊所进行。第 2 阶段的患者随机接受 ADM 的维持或停用治疗,并随访 3 年。第 1 名和最后 1 名患者分别于 2003 年 8 月和 2009 年 10 月进入第 2 阶段。最后 1 名患者于 2012 年 8 月完成第 2 阶段。数据于 2013 年 12 月至 2018 年 12 月进行分析。

干预措施:ADM 的维持或停用治疗。

主要结果和测量:使用纵向间隔随访评估 MDD 发作的复发情况;在两个阶段均持续康复。

结果:共有 292 名参与者(171 名女性,121 名男性;平均[SD]年龄 45.1[12.9]岁)纳入了抑郁复发分析。与 ADM 停药相比,ADM 维持治疗的复发率较低,无论患者在第 1 阶段是否单独使用 ADM(48.5%比 74.8%;z=-3.16;P=0.002;需要治疗的人数[NNT],2.8;95%CI,1.8-7.0)还是 ADM 联合 CBT(48.5%比 76.7%;z=-3.49;P<0.001;NNT,2.7;95%CI,1.9-5.9)。持续康复率因第 2 阶段的条件而异,ADM 维持治疗优于 ADM 停药(z=2.90;P=0.004;比值比[OR],2.54;95%CI,1.37-4.84;NNT,2.3;95%CI,1.5-6.4)。第 1 阶段的条件与持续康复的差异无关(ADM 单独与 ADM 联合 CBT;z=0.22;P=0.83;OR,1.08;95%CI,0.52-2.11;NNT,26.0;95%CI,需要伤害的人数 3.2 到 NNT 2.8),第 1 阶段的条件和第 2 阶段的条件之间也没有显著的相互作用(z=0.30;P=0.77;OR,1.14;95%CI,0.49-2.88)。

结论和相关性:ADM 维持治疗,但不是先前接触 CBT,与降低抑郁复发率有关。在以前的研究中,当 CBT 在没有 ADM 的情况下提供时,CBT 对抑郁复发有预防作用。CBT 是否也对抑郁复发有预防作用,或者添加 ADM 是否会干扰任何这种预防作用,尚不清楚。

试验注册:ClinicalTrials.gov 标识符:NCT00057577。

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