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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
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.
Mental Health Center of Peristeri, department of the Psychiatric Hospital of Attica, Ploutonos 19
Peristeri, Attica, Greece
Beck Depression Inventory-II
self-report questionnaire
Time frame: 2 months
Healthy Lifestyle and Personal Control Questionnaire
self-report questionnaire
Time frame: 2 months
Depression-Anxiety-Stress Scale-21
self-report questionnaire
Time frame: 2 months
Positive and Negative Affect Schedule
self-report questionnaire
Time frame: 2 months
Pittsburg Sleep Quality Index
self-report questionnaire
Time frame: 2 months
Brief International Assessment of Cognition for Multiple Sclerosis
battery of three cognitive tests
Time frame: 2 months
Hair cortisol concentration
Hair specimens from the posterior vertex of the scalp, three proximal to scalp cms
Time frame: 2 months
Salivary cortisol concentration
saliva specimens,three measurements in 24 hours: two in the morning (on awakening and 40 minutes later) and one at night (at 8:00). CAR and diurnal slope of cortisol were also calculated
Time frame: 2 months
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