Coping Strategies, Loneliness, and Resilience in Patients With Dermatosis (ESDaP3)
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Emilie Dr BRENAUT, Dermatologist
- Puhelinnumero: +33 2 98 22 35 90
- Sähköposti: emilie.brenaut@chu-brest.fr
Opiskelupaikat
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Brest, Ranska, 29200
- CHU Brest
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Muut: Case group (Patients with skin disease)
Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases)
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Muut: Control group (people without skin conditions)
People without skin conditions
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Aikaikkuna: 1 day
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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:
The analysis is conducted by subscale (each strategy), with scores ranging from 2 to 8. The interpretation depends on the coping strategy being measured:
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1 day
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To assess loneliness in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Aikaikkuna: 1 day
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UCLA Loneliness Scale - short Form (ULS-8) The questionnaire consists of 8 items, each rated on a scale of 1 to 4:
A high score indicates a high level of loneliness. |
1 day
|
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To assess resilience in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Aikaikkuna: 1 day
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Brief Resilience Scale (BRS), it consists of 6 items. Each item is rated on a scale of 1 to 5:
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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Assess patients' sleep compared to controls.
Aikaikkuna: 1 day
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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
Total score: Minimum = 0, Maximum = 28 A high score indicates a more severe form of insomnia. |
1 day
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Assess patients' anxiety levels compared to controls.
Aikaikkuna: 1 day
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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
Total score: Minimum = 0, Maximum = 6 A high score indicates a higher level of anxiety. |
1 day
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Assess patients' depression levels compared to a control group.
Aikaikkuna: 1 day
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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
Total score: Minimum = 0, Maximum = 6 A high score indicates a higher level of depressive symptoms |
1 day
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Assess patients' quality of life in comparison with a control group.
Aikaikkuna: 1 day
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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
Total score: Minimum = 0, Maximum = 30 A high score indicates a greater impact of the skin condition on quality of life |
1 day
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Assess patients' well-being in comparison with a control group.
Aikaikkuna: 1 day
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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
Total score: Minimum = 0, Maximum = 25 A lower score indicates better skin well-being. |
1 day
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Assessing the impact of dermatosis on the partner
Aikaikkuna: 1 day
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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
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
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 29BRC25.0465
- 2025-A02798-41 (Muu tunniste: Agence Nationale de Sécurité du Médicament et des produits de santé)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
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