Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stress and Depression: Interventional, Non-pharmaceutical Stress Management Program With the Cognitive Restructuring Method Pythagorean Self-Awareness for Patients Diagnosed With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Pythagorean Self-Awareness Intervention program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: major depressive disorder diagnosis conducted by a psychiatrist of the center according to the DSM-V criteria residency in Attica ability to speak and write fluently in the Greek language Exclusion Criteria: antecedent psychotic or manic episode current feeding or eating disorder, obsessive-compulsive disorder, self-harming behaviors or recent suicide attempt and current drug abuse or addiction current treatment with Cognitive-Behavioral Therapy denial to participate in the research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>34 participants. Received Pythagorean Self-Awareness program | Behavioral: Pythagorean Self-Awareness Intervention program<br>* 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.<br>|
| No Intervention: Control group<br>35 participants. Received usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory-II | self-report questionnaire | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy Lifestyle and Personal Control Questionnaire | self-report questionnaire | 2 months | 
| Depression-Anxiety-Stress Scale-21 | self-report questionnaire | 2 months | 
| Positive and Negative Affect Schedule | self-report questionnaire | 2 months | 
| Pittsburg Sleep Quality Index | self-report questionnaire | 2 months | 
| Brief International Assessment of Cognition for Multiple Sclerosis | battery of three cognitive tests | 2 months | 
| Hair cortisol concentration | Hair specimens from the posterior vertex of the scalp, three proximal to scalp cms | 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 | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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major depression, stress management program