The effects of Pythagorean Self-Awareness Intervention on patients with major depressive disorder: A pilot randomized controlled trial.

Stress plays an important role in major depressive disorder (MDD). Thus, a variety of stress management programs have been developed for people with this diagnosis. This is a pilot randomized clinical trial which implemented a holistic stress management program, Pythagorean Self-Awareness Intervention (PSAI) in adults with MDD, aiming to evaluate the effectiveness of PSAI compared to standard care for reduction of depressive symptoms (primary aim), improving mental health and quality of life (secondary aims). A total of 69 participants were randomized to an intervention group (N = 34), who received the usual care provided for patients with major depression and attended the PSAI program, and a control group (N = 35), who received the usual care only. Measurements were taken in both groups before and after the intervention and included: 1. Self-report questionnaires for measuring depressive symptoms, healthy lifestyle, perceived stress, anxiety, positive and negative affect and sleep quality, 2 Cognitive function assessment tools, 3. Hair and salivary cortisol. The intervention group demonstrated significantly greater reductions in depressive symptoms, negative affect, perceived stress, sleep quality and significantly greater increase in visual memory and healthy lifestyle compared to the control group. In addition, the intervention group demonstrated a significant reduction in first morning salivary cortisol, indicating a reduction in diurnal stress levels, while no significant change of salivary cortisol was observed in the control group. Finally, none of the study's groups demonstrated a significant change in hair cortisol concentration. In conclusion, PSAI can be applied to adults suffering from MDD with significant benefits for their mental health and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04536714.