Mehnert Anja, Koranyi Susan, Philipp Rebecca, Scheffold Katharina, Kriston Levente, Lehmann-Laue Antje, Engelmann Dorit, Vehling Sigrun, Eisenecker Christina, Oechsle Karin, Schulz-Kindermann Frank, Rodin Gary, Härter Martin
Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Leipzig, Germany.
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Psychooncology. 2020 Nov;29(11):1895-1904. doi: 10.1002/pon.5521. Epub 2020 Sep 14.
We aimed to determine whether the Managing Cancer and Living Meaningfully (CALM) therapy is superior to a non-manualized supportive psycho-oncological counselling intervention (SPI).
Adult patients with advanced cancer and ≥9 points on the PHQ-9 and/or ≥5 points on the DT were randomized to CALM or SPI. We hypothesized that CALM patients would report significantly less depression (primary outcome) on the BDI-II and the PHQ-9 6 months after baseline compared to SPI patients.
From 329 eligible patients, 206 participated (61.2% female; age: M = 57.9 [SD = 11.7]; 84.5% UICC IV stage). Of them, 99 were assigned to CALM and 107 to SPI. Intention-to-treat analyses revealed significantly less depressive symptoms at 6 months than at baseline (P < .001 for BDI-II and PHQ-9), but participants in the CALM and SPI group did not differ in depression severity (BDI-II: P = .62, PHQ-9: P = .998). Group differences on secondary outcomes were statistically not significant either.
CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group.
我们旨在确定“管理癌症与有意义地生活”（CALM）疗法是否优于非手册化的支持性心理肿瘤咨询干预（SPI）。
将PHQ - 9评分≥9分和/或DT评分≥5分的成年晚期癌症患者随机分为CALM组或SPI组。我们假设，与SPI组患者相比，CALM组患者在基线后6个月时在BDI - II和PHQ - 9量表上报告的抑郁症状（主要结局）会显著减少。
在329名符合条件的患者中，206名参与研究（61.2%为女性；年龄：M = 57.9 [标准差 = 11.7]；84.5%为国际抗癌联盟（UICC）IV期）。其中，99名被分配到CALM组，107名被分配到SPI组。意向性分析显示，6个月时的抑郁症状明显少于基线时（BDI - II和PHQ - 9量表P < .001），但CALM组和SPI组患者在抑郁严重程度上没有差异（BDI - II量表：P = .62，PHQ - 9量表：P = .998）。次要结局的组间差异在统计学上也不显著。
CALM疗法与抑郁症状随时间减少有关，但这种改善在统计学上与SPI组内获得的改善没有显著差异。
