Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The present study explored the effects of the implementation of the Pythagorean Self Awarenes
      Intervention (PSAI) on patients diagnosed with major depressive disorder. The primary aim was
      to evaluate the effectiveness of PSAI compared to the usual care provided for adults with
      major depressive disorder with respect to the reduction of depressive symptoms. Secondary
      aims of this study included reduction of stress and anxiety, enhancement of healthy lifestyle
      and improvement of affect, sleep quality and cognitive functions of patients.
    

Detailed description: 
      Study design This randomized controlled trial was conducted at the Mental Health Center of
      Peristeri, department of the Psychiatric Hospital of Attica, Greece, from December 2018 to
      January 2020. The study protocol was approved by the School of Medicine, National and
      Kapodistrian University of Athens (Protocol n. 1718038002/30/07/2018) and the center's
      directorate and was consistent with the Declaration of Helsinki. All participants were
      enlisted in the study only after being fully informed by the researcher about the aims and
      procedures of the research and submitting written consent.

      Procedures Patients eligible for the above mentioned criteria were randomized in two groups:
      the intervention group, receiving PSAI, and the control group, receiving the usual care
      provided by the center for patients with MDD, namely medical treatment and counselling.
      Randomization was conducted based on random numbers generated by an online random number
      generator (https://www.sealedenvelope.com/simple-randomiser/v1/lists). This study was
      non-blinded, as patients and researchers were aware of the group assignment.
    

Intervention name(s): Pythagorean Self-Awareness Intervention program
Intervention type(s): Behavioral
Intervention description(s): Stress management program of Pythagorean Self-Awareness Intervention (PSAI), which included eight sessions and lasted for eight weeks. On the first week, a personal session took place for measurements and training in the relaxation technique of diaphragmatic breathing. In the second week, patients attended a group session, in which they were adviced to follow specific directions for a healthy lifestyle, such as organized physical activity, adherence to the Mediterranean diet, creating a daily routine. In the third week, participants were introduced to the cognitive restructuring technique of (PSAI).In the following four group sessions, patients were trained on PSAI and the second relaxation technique, progressive muscular relaxation. In the last week, the final measurements were made. All sessions lasted for 120 minutes, except for the final one, which lasted for 60 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depression; stress management program