辅助认知行为疗法对药物治疗抵抗性抑郁症的疗效：一项随机对照试验。

Effectiveness of Supplementary Cognitive-Behavioral Therapy for Pharmacotherapy-Resistant Depression: A Randomized Controlled Trial.

作者信息

Nakagawa Atsuo, Mitsuda Dai, Sado Mitsuhiro, Abe Takayuki, Fujisawa Daisuke, Kikuchi Toshiaki, Iwashita Satoru, Mimura Masaru, Ono Yutaka

机构信息

Center for Clinical Research, Keio University School of Medicine, Shinanomachi 35, Shinjuku-ku, Tokyo 160-8582, Japan.

Center for Clinical Research, Keio University School of Medicine, Tokyo, Japan.

出版信息

J Clin Psychiatry. 2017 Sep/Oct;78(8):1126-1135. doi: 10.4088/JCP.15m10511.

DOI:10.4088/JCP.15m10511

PMID:28252882

Abstract

OBJECTIVE

Antidepressant medication is efficacious in the treatment of depression, but not all patients improve with antidepressant medication alone. Despite this treatment gap, limited evidence regarding the effectiveness of supplementing psychotherapy for pharmacotherapy-resistant depression is available. Therefore, we investigated the effectiveness of supplementing usual medication management (treatment as usual [TAU]) with cognitive-behavioral therapy (CBT) in patients with pharmacotherapy-resistant depression seeking psychiatric specialty care.

METHODS

A 16-week assessor-masked randomized controlled trial with a 12-month follow-up was conducted in 1 university hospital and 1 psychiatric hospital from September 2008 to December 2014. Outpatients aged 20-65 years with pharmacotherapy-resistant depression (taking antidepressant medications for ≥ 8 weeks, 17-item GRID-Hamilton Depression Rating Scale [GRID-HDRS₁₇] score ≥ 16, Maudsley Staging Method for treatment-resistant depression score ≥ 3, and DSM-IV criteria for major depressive disorder) were randomly assigned (1:1) to CBT combined with TAU or to TAU alone. The primary outcome was the alleviation of depressive symptoms, as measured by change in the total GRID-HDRS₁₇ score from baseline to 16 weeks; primary analysis was done on an intention-to-treat basis.

RESULTS

A total of 80 patients were randomized; 78 (97.5%) were assessed for the primary outcome, and 73 (91.3%) were followed up for 12 months. Supplementary CBT significantly alleviated depressive symptoms at 16 weeks, as shown by greater least squares mean changes in GRID-HDRS₁₇ scores in the intervention group than in the control group (-12.7 vs -7.4; difference = -5.4; 95% CI, -8.1 to -2.6; P < .001), and the treatment effect was maintained for at least 12 months (-15.4 vs -11.0; difference = -4.4; 95% CI, -7.2 to -1.6; P = .002).

CONCLUSIONS

Patients with pharmacotherapy-resistant depression treated in psychiatric specialty care settings may benefit from supplementing usual medication management with CBT.

TRIAL REGISTRATION

UMIN Clinical Trials Registry identifier: UMIN000001218.

摘要

目的

抗抑郁药物在抑郁症治疗中有效，但并非所有患者仅使用抗抑郁药物就能改善病情。尽管存在这种治疗差距，但关于补充心理治疗对药物治疗抵抗性抑郁症有效性的证据有限。因此，我们调查了在寻求精神科专科护理的药物治疗抵抗性抑郁症患者中，用认知行为疗法（CBT）补充常规药物管理（常规治疗[TAU]）的有效性。

方法

2008年9月至2014年12月在1所大学医院和1所精神病医院进行了一项为期16周的评估者盲法随机对照试验，并进行了12个月的随访。年龄在20 - 65岁之间、患有药物治疗抵抗性抑郁症（服用抗抑郁药物≥8周，17项汉密尔顿抑郁量表[GRID - HDRS₁₇]评分≥16，莫兹利难治性抑郁症分期法评分≥3，以及符合DSM - IV重度抑郁症标准）的门诊患者被随机分配（1:1）至CBT联合TAU组或仅TAU组。主要结局是抑郁症状的缓解，通过从基线到16周GRID - HDRS₁₇总分的变化来衡量；主要分析基于意向性分析。

结果

共有80名患者被随机分组；78名（97.5%）接受了主要结局评估，73名（91.3%）进行了12个月的随访。补充CBT在16周时显著缓解了抑郁症状，干预组GRID - HDRS₁₇评分的最小二乘均值变化大于对照组（-12.7对-7.4；差异=-5.4；95%CI，-8.1至-2.6；P <.001），且治疗效果维持了至少12个月（-15.4对-11.0；差异=-4.4；95%CI，-7.2至-1.6；P =.002）。