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Not yet recruiting NCT07640373

Coping Strategies, Loneliness, and Resilience in Patients With Dermatosis

No phase Interventional Skin Disease Skin Disorder Skin Condition Inflammatory Skin Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: Skin Disease, Skin Disorder, Skin Condition, Inflammatory Skin Conditions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Other 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

Primary outcome measures

  • To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin. [Time frame: 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. [Time frame: 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. [Time frame: 1 day]
Secondary outcome measures (6)
  • Assess patients' sleep compared to controls. [Time frame: 1 day]
  • Assess patients' anxiety levels compared to controls. [Time frame: 1 day]
  • Assess patients' depression levels compared to a control group. [Time frame: 1 day]
  • Assess patients' quality of life in comparison with a control group. [Time frame: 1 day]
  • Assess patients' well-being in comparison with a control group. [Time frame: 1 day]
  • Assessing the impact of dermatosis on the partner [Time frame: 1 day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • CHU Brest — Brest

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗