Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder

E

Evgenia E. Psarraki

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Behavioral: Pythagorean Self-Awareness Intervention program

Study type

Interventional

Funder types

Other

Identifiers

NCT04536714
Prot.1 26/8/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

69 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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