Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04536714
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2020-08-26
Brief Title:
Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder
Sponsor:
Evgenia E Psarraki
Organization:
National and Kapodistrian University of Athens
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 171803800230072018 and the centers 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 httpswwwsealedenvelopecomsimple-randomiserv1lists This study was non-blinded as patients and researchers were aware of the group assignment
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 httpswwwsealedenvelopecomsimple-randomiserv1lists This study was non-blinded as patients and researchers were aware of the group assignment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None