Stress and Depression: Interventional, Non-pharmaceutical Stress Management Program With the Cognitive Restructuring Method "Pythagorean Self-Awareness" for Patients Diagnosed With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory-II
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention group
34 participants. Received Pythagorean Self-Awareness program
干预措施: Pythagorean Self-Awareness Intervention program (Behavioral)
Control group
35 participants. Received usual care
结局指标
主要结局
Beck Depression Inventory-II
时间窗: 2 months
self-report questionnaire
次要结局
- 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)
研究者
Evgenia E. Psarraki
MSc
National and Kapodistrian University of Athens