Pythagorean Self-Awareness Intervention on Psoriasis Patients. (PSAIPSORIASI)

November 14, 2024 updated by: Christina Darviri, National and Kapodistrian University of Athens

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 161 21
        • Andreas Syggros Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Pretest T0
Usual care
No Intervention: Pretest T1
Usual care
Experimental: Post-test T2
PSAI
Behavioral: 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.
Other Names:
  • PSAI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale (PSS-14)
Time Frame: 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.
Two times before the intervention (with 1 month distance) and 4 months after baseline measurements
Hair cortisol
Time Frame: 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.
Two times before the intervention (with 1 month distance) and 4 months after baseline measurement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: 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.
Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
Pittsburgh Sleep Quality Index
Time Frame: 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
Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
Healthy Life-style and Personal Control Questionnaire
Time Frame: 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
Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
Cognitive assessment
Time Frame: 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.
Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
Anger evaluation
Time Frame: 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.
Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
Shame, Guilt and Pride assessment
Time Frame: 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".
Two times before the intervention (with 1 month distance) and 4 months after baseline measurement
Health Locus of Control (HLC)
Time Frame: 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.
Two times before the intervention (with 1 month distance) and 4 months after baseline measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National and Kapodistrian University of Athens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christina Darviri, Professor, Postgraduate Course of Stress Science & Health Promotion, NKUA, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 472 /07-12-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Upon request after publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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