RESUMEN
OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.