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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Emilie Dr BRENAUT, Dermatologist
- Número de teléfono: +33 2 98 22 35 90
- Correo electrónico: emilie.brenaut@chu-brest.fr
Ubicaciones de estudio
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Brest, Francia, 29200
- CHU Brest
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Case group (Patients with skin disease)
Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases)
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Otro: Control group (people without skin conditions)
People without skin conditions
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 1 day
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assess patients' sleep compared to controls.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
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.
Periodo de tiempo: 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
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.
Periodo de tiempo: 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
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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de la piel y del tejido conectivo
- Enfermedades de la piel
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Encuestas y cuestionarios
Otros números de identificación del estudio
- 29BRC25.0465
- 2025-A02798-41 (Otro identificador: Agence Nationale de Sécurité du Médicament et des produits de santé)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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