Clinical trial NCT04536714: Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: major depression
stress management program
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Beck Depression Inventory-II
timeFrame: 2 months
Secondary outcomes:
measure: Healthy Lifestyle and Personal Control Questionnaire
timeFrame: 2 months
measure: Depression-Anxiety-Stress Scale-21
timeFrame: 2 months
measure: Positive and Negative Affect Schedule
timeFrame: 2 months
measure: Pittsburg Sleep Quality Index
timeFrame: 2 months
measure: Brief International Assessment of Cognition for Multiple Sclerosis
timeFrame: 2 months
measure: Hair cortisol concentration
timeFrame: 2 months
measure: Salivary cortisol concentration
timeFrame: 2 months
Other outcomes:
Locations:
city: Peristeri
country: Greece
facility: Mental Health Center of Peristeri, department of the Psychiatric Hospital of Attica, Ploutonos 19
state: Attica
Study officials:
affiliation: MSc "The Science of Stress and Health Promotion", School of Medicine, NKU Athens
name: Evgenia E Psarraki, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: MSc "The Science of Stress and Health Promotion", School of Medicine, NKU Athens
name: Christina Darviri, Dr
role: STUDY_DIRECTOR
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