RESUMO
OBJECTIVE: Depression is a global key challenge in mental health care. The implementation of effective, low-risk and cost-effective interventions to reduce its disease burden is a necessity. The aim of this study was to investigate the efficacy of the new Meditation-Based Lifestyle Modification (MBLM) program, a "second-generation" mindfulness-based intervention, in depressive outpatients. METHODS: Eighty-one patients with mild to moderate depression were randomized into three groups: intervention group (MBLM), control group (CONTROL), and treatment as usual group (TAU). The primary outcome was the change of depressive symptoms as administered by the Beck Depression Inventory-II (BDI-II) after 4 and 8 weeks. Secondary outcome variables included the Brief Symptom Checklist-18 and the Perceived Stress Scale-10. A 6-month follow-up was conducted. RESULTS: A greater reduction of depressive symptoms was found in MBLM participants compared to CONTROL (p < .001, ηp2 = 0.11, d = 0.70) and TAU ( p<.001,ηp2=0.10,d=0.67$p\lt .001,{\eta }_{{\rm{p}}}^{2}=0.10,d=0.67$ ) with a 13.15 points reduction of BDI-II score versus 1.71 points (CONTROL) and 3.34 points (TAU) after 8 weeks. Between-group post hoc tests for all secondary outcomes and at follow-up also yielded significant between-group differences with medium to large effect sizes in favor of MBLM. CONCLUSIONS: Study results showed beneficial effects of MBLM in depressed outpatients. Further high-quality controlled clinical studies including qualitative research are needed to investigate the specific and unspecific effects of the MBLM program in depression and other medical conditions.