Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536714
• Other study ID #: Prot.1 26/8/2020
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: January 21, 2020

Study information

• Verified date: August 2020
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 21, 2020
• Est. primary completion date: January 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Greece	Mental Health Center of Peristeri, department of the Psychiatric Hospital of Attica, Ploutonos 19	Peristeri	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Evgenia E. Psarraki

Country where clinical trial is conducted

Greece, 

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

Outcome

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