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PsoriasisPSAIPSORIASINCT06691763

Pythagorean Self-Awareness Intervention on Psoriasis Patients.

A study testing Pythagorean Self-Awareness Intervention for stress management and health promotion in people with Psoriasis, run by National and Kapodistrian University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psoriasis
What is being tested?
Pythagorean Self-Awareness Intervention for stress management and health promotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteGreece
Study dates
4 Dec 2023to 10 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Andreas Syggros Hospital

    Athens, 161 21

Other trials in Greece

About this study

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.

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.

Read the 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).

Conditions
Psoriasis
Being tested
Pythagorean Self-Awareness Intervention for stress management and health promotion
Keywords
Psoriasis, Pythagorean self-awareness intervention, Stress management, Perceived stress, Sleep quality, Cognitive function, Hair Cortisol, Clinical samples
Medical subject headings
Psoriasis, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pythagorean Self-Awareness Intervention for stress management and health promotionBehavioural

    Also called PSAI

    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.

Study groups in NCT06691763
Study groupRoleWhat they receive
Pretest T0No interventionUsual care
Pretest T1No interventionUsual care
Post-test T2ExperimentalPSAI
Receives: Behavioral: Pythagorean Self-Awareness Intervention for stress management and health promotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (7)

  1. Heart Rate Variability

    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.

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

  2. Pittsburgh Sleep Quality Index

    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

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

  3. Healthy Life-style and Personal Control Questionnaire

    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

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

  4. Cognitive assessment

    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.

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

  5. Anger evaluation

    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.

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

  6. Shame, Guilt and Pride assessment

    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".

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

  7. Health Locus of Control (HLC)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2024
  2. Study start4 Dec 2023
  3. Primary completion8 Jul 2024
  4. Study completion10 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
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.
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06691763
Sponsor's protocol ID
472 /07-12-2023
Acronym
PSAIPSORIASI
Status last verified
Nov 2024
First submitted
11 Nov 2024
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Upon request after publication

Publications

  • 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.

    PubMed 34128954

  • 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.

    PubMed 33894540

  • 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.

    PubMed 34972923

  • 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.

    PubMed 31901782

  • 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.

    PubMed 34217756

Questions about this trial

What is this clinical trial studying?

A study testing Pythagorean Self-Awareness Intervention for stress management and health promotion in people with Psoriasis, run by National and Kapodistrian University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Stress Scale (PSS-14) (time frame: Two times before the intervention (with 1 month distance) and 4 months after baseline measurements). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06691763, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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