Pythagorean Self-Awareness Intervention on Psoriasis Patients.

NCT ID: NCT06691763

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2024-09-10

Brief Summary

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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

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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).

Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pretest T0

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Pretest T1

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-test T2

PSAI

Group Type EXPERIMENTAL

Pythagorean Self-Awareness Intervention for stress management and health promotion

Intervention Type 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.

Interventions

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Pythagorean Self-Awareness Intervention for stress management and health promotion

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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PSAI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Christina Darviri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christina Darviri, Professor

Role: STUDY_DIRECTOR

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

Locations

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Andreas Syggros Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 34128954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33894540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34972923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31901782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34217756 (View on PubMed)

Other Identifiers

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472 /07-12-2023

Identifier Type: -

Identifier Source: org_study_id

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