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NCT Number: NCT04536714

Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Center of Peristeri, department of the Psychiatric Hospital of Attica, Ploutonos 19

Peristeri, Attica, 12135, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pythagorean Self-Awareness Intervention program

Behavioral

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.

Primary outcomes

  1. Beck Depression Inventory-II

    Time frame: 2 months

    self-report questionnaire

Secondary outcomes

  1. Healthy Lifestyle and Personal Control Questionnaire

    Time frame: 2 months

    self-report questionnaire

  2. Depression-Anxiety-Stress Scale-21

    Time frame: 2 months

    self-report questionnaire

  3. Positive and Negative Affect Schedule

    Time frame: 2 months

    self-report questionnaire

  4. Pittsburg Sleep Quality Index

    Time frame: 2 months

    self-report questionnaire

  5. Brief International Assessment of Cognition for Multiple Sclerosis

    Time frame: 2 months

    battery of three cognitive tests

  6. Hair cortisol concentration

    Time frame: 2 months

    Hair specimens from the posterior vertex of the scalp, three proximal to scalp cms

  7. Salivary cortisol concentration

    Time frame: 2 months

    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

Sponsors and collaborators

Lead sponsor

Evgenia E. Psarraki

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 3, 2020
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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