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

5. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

375

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Case group (Patients with skin disease)
Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases)
Sonstiges: 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
Sonstiges: Control group (people without skin conditions)
People without skin conditions
Sonstiges: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Assess patients' sleep compared to controls.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Brest

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juli 2029

Studienabschluss (Geschätzt)

1. Oktober 2029

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

All collected data that underlie results in a publication

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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