Coping Strategies, Loneliness, and Resilience in Patients With Dermatosis (ESDaP3)

June 5, 2026 updated by: University Hospital, Brest

The European Society for Dermatology & Psychiatry (ESDaP) studies the connection between the skin and the mind. Two previous studies of this type were conducted in 13 and 15 European countries, respectively. The first study assessed the psychological impact of skin diseases (anxiety, depression, sleep disorders), and the second analyzed feelings of stigma, stress, and body dysmorphic disorder (an abnormal perception of one's body).

In this study, new psychological variables will be examined: coping strategies, loneliness, and resilience.

A total of 23 centers will participate in the ESDaP3 study, located in 15 European countries (Austria, France, Germany, Hungary, Italy, North Macedonia, the Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Turkey, and the United Kingdom).

The aim of this study is to examine coping strategies, loneliness, and resilience among patients with a skin condition. Coping strategies refer to the various ways a person uses to manage a difficult or stressful situation. Resilience refers to a person's ability to cope with difficult situations, adapt to changes or challenges, and regain a sense of balance despite obstacles. Other factors will be assessed: sleep, anxiety and depression, and quality of life. A questionnaire will be given to your potential partner to assess the impact of the skin condition on their life at this time.

At the study's sole French site, Brest University Hospital, 250 patients with a skin condition and 125 people without a skin condition will be enrolled.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

At the time of enrollment, the following data will be collected:

  • Demographic data: initials (first and last name); age; gender; educational level; marital status; employment status; socioeconomic status.
  • General health status: EQ-5D-5L (VAS scale), suicidal thoughts, medical history (chronic skin disease, cardiovascular disease, pulmonary disease, diabetes, rheumatological disease, psychiatric illness)
  • Clinical data: Questions about the skin condition: duration, severity over the past year, current severity, frequency of flare-ups, current location of lesions, presence and intensity of pruritus, presence of associated sensations

Self-report questionnaires:

  • Coping strategies: Brief COPE questionnaire (dispositional format)
  • Loneliness: UCLA Loneliness Scale (ULS-8)
  • Resilience: Brief Resilience Scale (BRS)
  • Sleep: Insomnia Severity Index Questionnaire (ISI)
  • Anxiety: Generalized Anxiety Disorder 2 (GAD-2)
  • Depression: Patient Health Questionnaire-2 (PHQ-2)
  • Quality of life: Dermatology Life Quality Index (DLQI)
  • Well-being: Skin Well-Being Scale
  • Impact of dermatosis on the partner: FROM-16 (Family Reported Outcome Measure-16)

The estimated time to complete the questionnaires is 20 minutes; this will also be the duration of participation in this study.

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 (Estimated)

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.
375

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Brest, France, 29200
        • CHU Brest

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

Yes

Description

Inclusion Criteria:

  • Patients with skin conditions (inflammatory, autoimmune, cancerous, or genetic skin disorders)
  • Controls: individuals without skin disease
  • Adult participant
  • Participant enrolled in a Social Security system or equivalent
  • Participant who has given consent to participate in the study

Exclusion Criteria:

  • Participants who are unable to understand the protocol
  • Participants under legal guardianship (guardianship, conservatorship)
  • Participants subject to a future protection order, family authorization, or court-ordered protection
  • Participants who are unable to complete the questionnaires

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel 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.
Other: Case group (Patients with skin disease)
Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases)
Other: Questionnaires
  • Coping strategies: Brief COPE questionnaire (dispositional format)
  • Loneliness: UCLA Loneliness Scale (ULS-8)
  • Resilience: Brief Resilience Scale (BRS)
  • Sleep: Insomnia Severity Index Questionnaire (ISI)
  • Anxiety: Generalized Anxiety Disorder 2 (GAD-2)
  • Depression: Patient Health Questionnaire-2 (PHQ-2)
  • Quality of life: Dermatology Life Quality Index (DLQI)
  • Well-being: Skin Well-Being Scale
  • Impact of dermatosis on the partner: FROM-16
Other: Control group (people without skin conditions)
People without skin conditions
Other: Questionnaires
  • Coping strategies: Brief COPE questionnaire (dispositional format)
  • Loneliness: UCLA Loneliness Scale (ULS-8)
  • Resilience: Brief Resilience Scale (BRS)
  • Sleep: Insomnia Severity Index Questionnaire (ISI)
  • Anxiety: Generalized Anxiety Disorder 2 (GAD-2)
  • Depression: Patient Health Questionnaire-2 (PHQ-2)
  • Quality of life: Dermatology Life Quality Index (DLQI)
  • Well-being: Skin Well-Being Scale
  • Impact of dermatosis on the partner: FROM-16

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
To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Time Frame: 1 day

Brief Coping Orientation to Problems Experienced Inventory (Brief COPE inventory) questionnaire (dispositional format) :

The questionnaire contains 28 items, divided into 14 coping strategies (2 items per strategy); each item is rated on a scale of 1 to 4:

  1. = I almost never do this
  2. = I do this sometimes
  3. = I do this often
  4. = I almost always do this

The analysis is conducted by subscale (each strategy), with scores ranging from 2 to 8.

The interpretation depends on the coping strategy being measured:

  • for adaptive strategies, a high score is generally positive
  • for less adaptive/dysfunctional strategies, a high score is generally negative
1 day
To assess loneliness in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Time Frame: 1 day

UCLA Loneliness Scale - short Form (ULS-8)

The questionnaire consists of 8 items, each rated on a scale of 1 to 4:

  1. = Never
  2. = Rarely
  3. = Sometimes
  4. = Often

A high score indicates a high level of loneliness.
1 day
To assess resilience in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Time Frame: 1 day

Brief Resilience Scale (BRS), it consists of 6 items.

Each item is rated on a scale of 1 to 5:

  1. = Strongly disagree
  2. = Disagree
  3. = Neither agree nor disagree
  4. = Agree
  5. = Strongly agree

The average of the 6 items is typically calculated (rather than the sum). Minimum score = 1, Maximum score = 5

A high score indicates greater resilience.
1 day

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
Assess patients' sleep compared to controls.
Time Frame: 1 day

Insomnia Severity Index Questionnaire (ISI)

The ISI consists of 7 items.

Each item is rated on a scale of 0 to 4:

0 = No problem

  1. = Mild
  2. = Moderate
  3. = Severe
  4. = Very severe

Total score: Minimum = 0, Maximum = 28

A high score indicates a more severe form of insomnia.
1 day
Assess patients' anxiety levels compared to controls.
Time Frame: 1 day

Generalized Anxiety Disorder 2 (GAD-2)

The GAD-2 consists of 2 items.

Each item is scored on a scale of 0 to 3:

0 = Never

  1. = Several days
  2. = More than half the days
  3. = Almost every day

Total score: Minimum = 0, Maximum = 6

A high score indicates a higher level of anxiety.
1 day
Assess patients' depression levels compared to a control group.
Time Frame: 1 day

Patient Health Questionnaire-2 (PHQ-2)

The PHQ-2 consists of 2 items.

Each item is scored on a scale of 0 to 3:

0 = Never

  1. = Several days
  2. = More than half the days
  3. = Almost every day

Total score: Minimum = 0, Maximum = 6

A high score indicates a higher level of depressive symptoms
1 day
Assess patients' quality of life in comparison with a control group.
Time Frame: 1 day

Dermatology Life Quality Index (DLQI)

The DLQI consists of 10 items.

Each item is scored on a scale of 0 to 3:

0 = Not at all / Not applicable

  1. = A little
  2. = A lot
  3. = Very much

Total score: Minimum = 0, Maximum = 30

A high score indicates a greater impact of the skin condition on quality of life
1 day
Assess patients' well-being in comparison with a control group.
Time Frame: 1 day

Skin Well Being Scale (SWBS)

The SWBS consists of 5 items.

Each item is rated on a scale of 0 to 5:

0. All the time

  1. Most of the time
  2. More than half the time
  3. Less than half the time
  4. Sometimes
  5. Never

Total score: Minimum = 0, Maximum = 25

A lower score indicates better skin well-being.
1 day
Assessing the impact of dermatosis on the partner
Time Frame: 1 day

Family Reported Outcome Measure (FROM-16)

The FROM-16 consists of 16 items.

Each item is rated on a scale of 0 to 2:

0 = Not at all

  1. = A little
  2. = A lot

Total score: Minimum = 0, Maximum = 32

A high score indicates a greater impact of the illness on the quality of life of family members.
1 day

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.
University Hospital, Brest

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cardiff University
Karolinska Institutet
Lund University
University of Bergen
University Hospital Muenster
University of Amsterdam
Leiden University Medical Center
Sisli Hamidiye Etfal Training and Research Hospital
Universidad de Zaragoza
Wroclaw Medical University
Szeged University
University of Skopje
University of Rzeszow
Malmö University
University of La Laguna
University of Graz
University of Stavanger
Universidade do Algarve
Justus-Liebig University Gießen Medical Center
The Royal London Hospital, UK

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 (Estimated)

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.
July 1, 2026

Primary Completion (Estimated)

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 1, 2029

Study Completion (Estimated)

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.
October 1, 2029

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).
May 27, 2026

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.
June 5, 2026

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.
June 10, 2026

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.
June 10, 2026

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.
June 5, 2026

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.
June 1, 2026

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.
  • 29BRC25.0465
  • 2025-A02798-41 (Other Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings