Clinical trial NCT06691763: Pythagorean Self-Awareness Intervention on Psoriasis Patients.
Official title: The Effect of Pythagorean Self-Awareness Technique on Patients with Psoriasis. the Alternations in Hair Cortisol Levels Via Affecting Hypothalamic-Pituitary-Adrenal Axis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Psoriasis
Pythagorean self-awareness intervention
Stress management
Perceived stress
Sleep quality
Cognitive function
Hair Cortisol
Clinical samples
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A one-group pretest-posttest design, incorporating two pretest measurements (i.e., a double pretest) to enhance the methodological rigor. Specifically, participants were assessed twice prior to the intervention (using both questionnaires and devices) and once after the intervention.
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of psoriasis
* Speaking and writing in Greek language

Exclusion Criteria:

* Use of oral corticosteroids
* Diagnosis of any serious mental disorder
* Drug addictions

Primary outcomes:
measure: Perceived Stress Scale (PSS-14)
timeFrame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurements
measure: Hair cortisol
timeFrame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
measure: Pittsburgh Sleep Quality Index
timeFrame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
measure: Healthy Life-style and Personal Control Questionnaire
timeFrame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
measure: Cognitive assessment
timeFrame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
measure: Anger evaluation
timeFrame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
measure: Shame, Guilt and Pride assessment
timeFrame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
measure: Health Locus of Control (HLC)
timeFrame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Andreas Syggros Hospital
Study officials:
affiliation: Postgraduate Course of Stress Science & Health Promotion, NKUA, Greece
name: Christina Darviri, Professor
role: STUDY_DIRECTOR
References:
citation: Panagopoulou Z, Artemiadis AK, Chrousos GP, Darviri C, Anagnostouli MC. Pythagorean Self-Awareness Intervention for Multiple Sclerosis Patients: A Quasi-Experimental Pragmatic Trial. Arch Clin Neuropsychol. 2022 Jan 17;37(1):125-132. doi: 10.1093/arclin/acab044.
citation: Psarraki EE, Bacopoulou F, Panagoulias E, Michou M, Pelekasis P, Artemiadis A, Chrousos GP, Darviri C. The effects of Pythagorean Self-Awareness Intervention on patients with major depressive disorder: A pilot randomized controlled trial. J Psychiatr Res. 2021 Jun;138:326-334. doi: 10.1016/j.jpsychires.2021.03.067. Epub 2021 Apr 13.
citation: Gorgili K, Artemiadis A, Bacopoulou F, Karatzas P, Tigani X, Vlachakis D, Kokka I, Varvogli L, Chrousos GP, Darviri C. The Effects of Pythagorean Self-Awareness Intervention on Irritable Bowel Syndrome Patients: A Non-randomized Controlled Trial. Adv Exp Med Biol. 2021;1337:345-354. doi: 10.1007/978-3-030-78771-4_39.
citation: Charalampopoulou M, Bacopoulou F, Syrigos KN, Filopoulos E, Chrousos GP, Darviri C. The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial. Breast. 2020 Feb;49:210-218. doi: 10.1016/j.breast.2019.12.012. Epub 2019 Dec 20.
citation: Athanasopoulou S, Simos D, Charalampopoulou M, Tentolouris N, Kokkinos A, Bacopoulou F, Aggelopoulou E, Zigkiri E, Chrousos GP, Darviri C, Gonos ES. Significant improvement of stress and aging biomarkers using a novel stress management program with the cognitive restructuring method "Pythagorean Self-Awareness Intervention" in patients with type 2 diabetes mellitus and healthy adults. Mech Ageing Dev. 2021 Sep;198:111538. doi: 10.1016/j.mad.2021.111538. Epub 2021 Jul 1.