Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Behavioral: Pythagorean Self-Awareness Intervention program
- Registration Number
- NCT04536714
- Lead Sponsor
- Evgenia E. Psarraki
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Pythagorean Self-Awareness Intervention program 34 participants. Received Pythagorean Self-Awareness program
- Primary Outcome Measures
Name Time Method Beck Depression Inventory-II 2 months self-report questionnaire
- Secondary Outcome Measures
Name Time Method Healthy Lifestyle and Personal Control Questionnaire 2 months self-report questionnaire
Brief International Assessment of Cognition for Multiple Sclerosis 2 months battery of three cognitive tests
Pittsburg Sleep Quality Index 2 months self-report questionnaire
Hair cortisol concentration 2 months Hair specimens from the posterior vertex of the scalp, three proximal to scalp cms
Salivary cortisol concentration 2 months 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
Depression-Anxiety-Stress Scale-21 2 months self-report questionnaire
Positive and Negative Affect Schedule 2 months self-report questionnaire
Trial Locations
- Locations (1)
Mental Health Center of Peristeri, department of the Psychiatric Hospital of Attica, Ploutonos 19
🇬🇷Peristeri, Attica, Greece