Pythagorean Self-Awareness Intervention on Psoriasis Patients.
- Conditions
- Psoriasis
- Registration Number
- NCT06691763
- Lead Sponsor
- National and Kapodistrian University of Athens
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Confirmed diagnosis of psoriasis
- Speaking and writing in Greek language
- Use of oral corticosteroids
- Diagnosis of any serious mental disorder
- Drug addictions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Perceived Stress Scale (PSS-14) 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 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.
- Secondary Outcome Measures
Name Time Method Heart Rate Variability Two times before the intervention (with 1 month distance) and 4 months after baseline measurement To collect HRV data via ECG, we utilized the NeXus hardware in combination with the BioTrace+ software (NeXus-10 version 2023; BioTrace+, Mind Media, Herten, the Netherlands). The NeXus system integrates HRV-BF with psychophysiological research and offers ECG data in both time and frequency domains using self-adhesive electrodes. The researcher manually initiated NeXus measurements at the start of the PPG data collection to ensure simultaneous acquisition of both PPG and ECG data.
Pittsburgh Sleep Quality Index Two times before the intervention (with 1 month distance) and 4 months after baseline measurement Sleep quality was assessed using the Greek version of the PSQI questionnaire. The PSQI consists of 19 self-report questions, grouped into 7 components (subjective sense of sleep quality, awakening time, latent period, duration, usual sleep productivity, use of sleep medication and daytime dysfunction). The score ranges from 0 to 3, resulting in a total score ranging from 0=high sleep quality to 21=low sleep quality. A total score of \> or = 5 indicates poor sleep
Healthy Life-style and Personal Control Questionnaire Two times before the intervention (with 1 month distance) and 4 months after baseline measurement The healthy lifestyle and self-monitoring questionnaire consists of 26 items, which are divided into a 4-point Likert scale ranging from 1=never/rarely to 4= always. A higher score indicates increased health empowerment. Specifically, the HLPCQ is designed to assess one's degree of control over daily activities such as diet, daily schedule, physical activity, socialization and pessimistic thoughts
Cognitive assessment Two times before the intervention (with 1 month distance) and 4 months after baseline measurement The standardized battery Brief Intentory for Cognitive Assessment(BICA) was used to assess cognitive functions in the participants. This memory assessment tool took about 15 minutes to complete is completed and included three categories of cognitive tests: The Normal Symbol Digital Modalities Test (SDMT), which measured information processing speed, the California Verbal Learning Test-II (CVLT-II), which assessed verbal memory and subsequent immediate recall. Finally, the third test concerned short visuospatial memory Test Revised (BVMTR), which assessed visual memory and immediate recall. Low scores indicated cognitive dysfunctions and cognitive decline. The specific tool for memory assessment has been proposed to help practitioners identify a potential cognitive dysfunction in humans.
Anger evaluation Two times before the intervention (with 1 month distance) and 4 months after baseline measurement The STAXI questionnaire examines how individuals respond or behave when they feel angry. The Greek version of the 24-item STAXI was utilized. The items are rated on a four-point Likert-type scale (1 ¼ almost never to 4 ¼ almost always) three subscales: not expressing anger, expressing anger, controlling anger.
Shame, Guilt and Pride assessment Two times before the intervention (with 1 month distance) and 4 months after baseline measurement The State Shame and Guilt Scale is a 15-item self-report questionnaire designed to assess shame, guilt and pride in response to a specific situation. Participants rate their responses on a 5-point Likert scale, ranging from "I don't feel that way at all" to "I feel very strongly that way".
Health Locus of Control (HLC) Two times before the intervention (with 1 month distance) and 4 months after baseline measurement The HLC scale was employed to assess participants' beliefs regarding their perceived control over their health. This 18-item scale is divided into three subscales: HLC internal, HLC external, and HLC chance (denoted as HLC-1, HLC-2, and HLC-3, respectively). The internal HLC subscale measures the extent to which an individual believes they are responsible for their own health and well-being. The HLC external subscale assesses the degree to which individuals attribute their health to external factors, such as other people or societal influences. The HLC subscale reflects beliefs that health outcomes are governed by chance or random factors beyond the individual's control. Higher scores on each subscale indicate a stronger belief in the corresponding type of control (internal, external, or chance) as a determinant of health.
Trial Locations
- Locations (1)
Andreas Syggros Hospital
🇬🇷Athens, Greece