Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder

NCT04536714 | Completed

• 1 other identifier: Prot.1 26/8/2020
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

major depression; stress management program

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory-II

  self-report questionnaire

  2 months

Secondary Outcomes (7)

• Healthy Lifestyle and Personal Control Questionnaire

  2 months

• Depression-Anxiety-Stress Scale-21

  2 months

• Positive and Negative Affect Schedule

  2 months

• Pittsburg Sleep Quality Index

  2 months

• Brief International Assessment of Cognition for Multiple Sclerosis

  2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

34 participants. Received Pythagorean Self-Awareness program

Behavioral: Pythagorean Self-Awareness Intervention program

Control group

NO INTERVENTION

35 participants. Received usual care

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evgenia E. Psarraki: lead

Study Sites (1)

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

Peristeri, Attica, 12135, Greece

Location

Related Publications (19)

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  PMID: 33894540 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Evgenia E Psarraki, MSc

  MSc "The Science of Stress and Health Promotion", School of Medicine, NKU Athens

  PRINCIPAL INVESTIGATOR

• Christina Darviri, Dr

  MSc "The Science of Stress and Health Promotion", School of Medicine, NKU Athens

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 3, 2020
• Study Start: December 3, 2018
• Primary Completion: January 21, 2020
• Study Completion: January 21, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)