Pythagorean Self-Awareness Intervention on Psoriasis Patients.

NCT06691763 | Completed

• 1 other identifier: 472 /07-12-2023
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Pythagorean self-awareness intervention; Stress management; Perceived stress; Sleep quality; Cognitive function; Hair Cortisol; Clinical samples

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Scale (PSS-14)

  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.

  Two times before the intervention (with 1 month distance) and 4 months after baseline measurements

• Hair cortisol

  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.

  Two times before the intervention (with 1 month distance) and 4 months after baseline measurement

Secondary Outcomes (7)

• 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

Study Arms (3)

Pretest T0

NO INTERVENTION

Usual care

Pretest T1

NO INTERVENTION

Usual care

Post-test T2

EXPERIMENTAL

PSAI

Behavioral: Pythagorean Self-Awareness Intervention for stress management and health promotion

Interventions

Pythagorean Self-Awareness Intervention for stress management and health promotion BEHAVIORAL

Pythagorean Self-Awareness is a holistic stress magement program that combines cognitive reconstruction and the implementation of the 6 pillars of life-style medicine depending on the targeted population.

Also known as: PSAI

Post-test T2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Andreas Syggros Hospital

Athens, 161 21, Greece

Location

Related Publications (5)

• 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.

  PMID: 34128954 BACKGROUND

• 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.

  PMID: 33894540 BACKGROUND

• 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.

  PMID: 34972923 BACKGROUND

• 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.

  PMID: 31901782 BACKGROUND

• 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.

  PMID: 34217756 BACKGROUND

MeSH Terms

Conditions

Psoriasis; Sleep Initiation and Maintenance Disorders

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Christina Darviri, Professor

  Postgraduate Course of Stress Science & Health Promotion, NKUA, Greece

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 15, 2024
• Study Start: December 4, 2023
• Primary Completion: July 8, 2024
• Study Completion: September 10, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)