Background: Methodologically well-designed RCTs concerning the efficacy of Hypnotherapy in the treatment of Major Depression are lacking. The aim of this study was to determine whether Hypnotherapy (HT) is not inferior to Cognitive Behavioral Therapy (CBT), the gold-standard psychotherapy, in the percentage reduction of depressive symptoms, assessed in mild to moderate Major Depression (MD).

Methods: This study reports the main results of a monocentric two-armed randomized-controlled rater-blind clinical trial. A total of 152 patients with MD were randomized to either CBT or HT receiving outpatient individual psychotherapy with 16 to 20 sessions for the duration of six months. The primary outcome was the mean percentage improvement in depressive symptoms assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) before and after treatment.

Results: The difference in the mean percentage symptom reduction between HT and CBT was 2.8 (95% CI=-9.85 to 15.44) in the Intention-to-treat sample and 4.0 (95% CI=-9.27 to 17.27) in the Per Protocol sample (N=134). Concerning the pre-specified non-inferiority margin of -16.4, both results confirm the non-inferiority of HT to CBT. The results for the follow-ups six and twelve months after the end of the treatment support the primary results.

Limitations: For ethical reasons the trial did not include a control group without treatment; therefore we can only indirectly conclude that both treatment conditions are effective.

Conclusion: This is the first study to demonstrate that HT was not inferior to CBT in MD, while employing rigorous methodological standards.

背景：缺乏关于催眠疗法治疗重度抑郁症的方法设计合理的随机对照试验。这项研究的目的是确定在轻度至中度重度抑郁症（MD）中评估的抑郁症状减少百分比中，催眠疗法（HT）是否不劣于认知行为疗法（CBT）（金标准心理疗法）。

方法：本研究报告了单中心两臂随机对照评分者盲临床试验的主要结果。总共152名MD患者被随机分为CBT或HT接受门诊个体心理治疗，共16到20个疗程，为期6个月。主要结局是治疗前后用蒙哥马利-阿斯伯格抑郁量表（MADRS）评估的抑郁症状平均改善百分比。

结果：意向性治疗样本中HT和CBT的平均症状减轻百分比差异为2.8（95％CI = -9.85至15.44），而按照规程为4.0（95％CI = -9.27至17.27）样本（N = 134）。关于预先规定的-16.4的非劣效性，这两个结果均证实了HT对CBT的非劣效性。治疗结束后六个月和十二个月的随访结果支持主要结果。

局限性：出于伦理原因，该试验不包括未经治疗的对照组；因此，我们只能间接得出结论，两种治疗条件都是有效的。

结论：这是第一项证明HT在采用严格的方法学标准的同时不低于MD的CBT的研究。