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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Emilie Dr BRENAUT, Dermatologist
- Número de telefone: +33 2 98 22 35 90
- E-mail: emilie.brenaut@chu-brest.fr
Locais de estudo
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Brest, França, 29200
- CHU Brest
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Case group (Patients with skin disease)
Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases)
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Outro: Control group (people without skin conditions)
People without skin conditions
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Prazo: 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.
Prazo: 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.
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Assess patients' sleep compared to controls.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças da Pele e do Tecido Conjuntivo
- Doenças de pele
- Qualidade, acesso e avaliação da assistência médica
- Técnicas de investigação
- Métodos epidemiológicos
- Coleta de dados
- Mecanismos de avaliação de saúde
- Qualidade de assistência médica
- Saúde pública
- Meio ambiente e saúde pública
- Pesquisas e questionários
Outros números de identificação do estudo
- 29BRC25.0465
- 2025-A02798-41 (Outro identificador: Agence Nationale de Sécurité du Médicament et des produits de santé)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
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