Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tuebingen, Germany.
Institute for Clinical Epidemiology and Applied Biometry, University of Tuebingen, Tuebingen, Germany.
J Affect Disord. 2021 May 1;286:166-173. doi: 10.1016/j.jad.2021.02.069. Epub 2021 Mar 5.
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).
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.
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.
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.
This is the first study to demonstrate that HT was not inferior to CBT in MD, while employing rigorous methodological standards.
缺乏关于催眠疗法治疗重度抑郁症疗效的方法学设计良好的 RCT 研究。本研究旨在确定催眠疗法(HT)是否不比认知行为疗法(CBT)差,CBT 是标准的心理治疗方法,在治疗轻度至中度重度抑郁症(MD)时,在抑郁症状的减轻百分比方面。
本研究报告了一项单中心、双臂、随机、对照、评估者盲法临床试验的主要结果。共有 152 名 MD 患者被随机分为 CBT 或 HT 组,接受门诊个体心理治疗,疗程为 6 个月,共 16-20 次。主要结局是治疗前后用蒙哥马利-阿斯伯格抑郁评定量表(MADRS)评估的抑郁症状平均百分比改善。
意向治疗样本中 HT 与 CBT 之间的平均症状缓解率差异为 2.8(95%CI=-9.85 至 15.44),协议样本(N=134)中差异为 4.0(95%CI=-9.27 至 17.27)。关于预先指定的非劣效性边界-16.4,两个结果均证实 HT 不劣于 CBT。治疗结束后 6 个月和 12 个月的随访结果支持主要结果。
出于伦理原因,该试验未包括无治疗的对照组;因此,我们只能间接地得出两种治疗条件均有效的结论。
这是第一项证明在 MD 中 HT 不劣于 CBT 的研究,同时采用了严格的方法学标准。