The Effect of Pythagorean Self-Awareness Technique on Patients with Psoriasis. the Alternations in Hair Cortisol Levels Via Affecting Hypothalamic-Pituitary-Adrenal Axis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Perceived Stress Scale (PSS-14)
研究概览
简要总结
This one-arm, pilot, non-randomized, study was conducted at the Specialized Psoriasis Unit of Andreas Syggros Hospital in Athens, Greece. All participants were informed about the objectives and procedures of the study, and written informed consent was provided prior to participation. The study protocol was approved by the hospital's Scientific and Ethics Committee (protocol number: 472 /07-12-2023)and was in accordance with the Declaration of Helsinki.
详细描述
Pythagorean Self-Awareness Intervention (PSAI) to a sample of psoriasis patients. Primary aim was the reduction of perceived stress levels. Secondary aims were the enhancement of stress response (HRV), increase cortisol levels, improvement of sleep quality, adoption of healthy behaviors, emotional regulation (e.g., shame and anger), cognitive performance enhancement (e.g., visual-spatial memory, verbal learning, information processing speed), as well as improvements in body composition indices (e.g., weight, body mass index (BMI), intermuscular adipose tissue (IMAT), fat mass, and free fat mass).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 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
- •Confirmed diagnosis of psoriasis
- •Speaking and writing in Greek language
排除标准
- •Use of oral corticosteroids
- •Diagnosis of any serious mental disorder
- •Drug addictions
研究组 & 干预措施
Pretest T0
Usual care
Pretest T1
Usual care
Post-test T2
PSAI
干预措施: Pythagorean Self-Awareness Intervention for stress management and health promotion (Behavioral)
结局指标
主要结局
Perceived Stress Scale (PSS-14)
时间窗: Two times before the intervention (with 1 month distance) and 4 months after baseline measurements
To assess perceived stress, the Greek version of the PSS questionnaire was administered, which consists of 14 items, each graded on a 5-point Likert scale. More specifically, there are seven positive and seven negative items and the total score ranges from 0 to 56. Higher PSS scores indicate higher levels of perceived in the past month.
Hair cortisol
时间窗: Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
Hair samples were collected from each participant twice prior to the intervention and once following the intervention. The samples were taken from the posterior vertex of the scalp. Cortisol levels were analyzed retrospectively by examining the hair segments. The proximal 1 cm segment closest to the scalp reflects cortisol secretion over the past month, while the second most proximal 1 cm segment represents cortisol production from the preceding month, and so on.
次要结局
- Heart Rate Variability(Two times before the intervention (with 1 month distance) and 4 months after baseline measurement)
- Pittsburgh Sleep Quality Index(Two times before the intervention (with 1 month distance) and 4 months after baseline measurement)
- Healthy Life-style and Personal Control Questionnaire(Two times before the intervention (with 1 month distance) and 4 months after baseline measurement)
- Cognitive assessment(Two times before the intervention (with 1 month distance) and 4 months after baseline measurement)
- Anger evaluation(Two times before the intervention (with 1 month distance) and 4 months after baseline measurement)
- Shame, Guilt and Pride assessment(Two times before the intervention (with 1 month distance) and 4 months after baseline measurement)
- Health Locus of Control (HLC)(Two times before the intervention (with 1 month distance) and 4 months after baseline measurement)
研究者
Christina Darviri
Professor
National and Kapodistrian University of Athens