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

5 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

375

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Frankrijk
      • Brest, Frankrijk, 29200
        • CHU Brest

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Case group (Patients with skin disease)
Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases)
Ander: 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
Ander: Control group (people without skin conditions)
People without skin conditions
Ander: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assess patients' sleep compared to controls.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Brest

Medewerkers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juli 2029

Studie voltooiing (Geschat)

1 oktober 2029

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 juni 2026

Eerst geplaatst (Werkelijk)

10 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

5 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

All collected data that underlie results in a publication

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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