Efficacy of the Managing Cancer and Living Meaningfully (CALM) individual psychotherapy for patients with advanced cancer: A single‐blind randomized controlled trial.

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. [ABSTRACT FROM AUTHOR]