Stress and Depression: Interventional, Non-pharmaceutical Stress Management Program With the Cognitive Restructuring Method "Pythagorean Self-Awareness" for Patients Diagnosed With Major Depressive Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Beck Depression Inventory-II
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention group
34 participants. Received Pythagorean Self-Awareness program
Intervention: Pythagorean Self-Awareness Intervention program (Behavioral)
Control group
35 participants. Received usual care
Outcomes
Primary Outcomes
Beck Depression Inventory-II
Time Frame: 2 months
self-report questionnaire
Secondary Outcomes
- Healthy Lifestyle and Personal Control Questionnaire(2 months)
- Brief International Assessment of Cognition for Multiple Sclerosis(2 months)
- Pittsburg Sleep Quality Index(2 months)
- Hair cortisol concentration(2 months)
- Salivary cortisol concentration(2 months)
- Depression-Anxiety-Stress Scale-21(2 months)
- Positive and Negative Affect Schedule(2 months)
Investigators
Evgenia E. Psarraki
MSc
National and Kapodistrian University of Athens