Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder

August 28, 2020 updated by: Evgenia E. Psarraki

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Peristeri, Attica, Greece, 12135
        • Mental Health Center of Peristeri, department of the Psychiatric Hospital of Attica, Ploutonos 19

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evgenia E. Psarraki

Investigators

  • Principal Investigator: Evgenia E Psarraki, MSc, MSc "The Science of Stress and Health Promotion", School of Medicine, NKU Athens
  • Study Director: Christina Darviri, Dr, MSc "The Science of Stress and Health Promotion", School of Medicine, NKU Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Actual)

January 21, 2020

Study Completion (Actual)

January 21, 2020

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

August 28, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot.1 26/8/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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