Coping Strategies, Loneliness, and Resilience in Patients With Dermatosis

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 1 day]

Вторичные конечные точки (6)

• Assess patients' sleep compared to controls. [Срок оценки: 1 day]
• Assess patients' anxiety levels compared to controls. [Срок оценки: 1 day]
• Assess patients' depression levels compared to a control group. [Срок оценки: 1 day]
• Assess patients' quality of life in comparison with a control group. [Срок оценки: 1 day]
• Assess patients' well-being in comparison with a control group. [Срок оценки: 1 day]
• Assessing the impact of dermatosis on the partner [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• CHU Brest — Brest

Идентификаторы

NCT: NCT07640373 · 29BRC25.0465 · 2025-A02798-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗