About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Questionnaires
Other intervention* 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
Treatment groups
Trial outcomes
Primary outcomes
To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
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: 1. = I almost never do this 2. = I do this sometimes 3. = I do this often 4. = I almost always do this The analysis is conducted by subscale (each strategy), with scores ranging from 2 to 8. The interpretation depends on the coping strategy being measured: * for adaptive strategies, a high score is generally positive * for less adaptive/dysfunctional strategies, a high score is generally negative
To assess loneliness in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
UCLA Loneliness Scale - short Form (ULS-8) The questionnaire consists of 8 items, each rated on a scale of 1 to 4: 1. = Never 2. = Rarely 3. = Sometimes 4. = Often A high score indicates a high level of loneliness.
To assess resilience in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
Brief Resilience Scale (BRS), it consists of 6 items. Each item is rated on a scale of 1 to 5: 1. = Strongly disagree 2. = Disagree 3. = Neither agree nor disagree 4. = Agree 5. = Strongly agree 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.
Secondary outcomes
Assess patients' sleep compared to controls.
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 1. = Mild 2. = Moderate 3. = Severe 4. = Very severe Total score: Minimum = 0, Maximum = 28 A high score indicates a more severe form of insomnia.
Assess patients' anxiety levels compared to controls.
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 1. = Several days 2. = More than half the days 3. = Almost every day Total score: Minimum = 0, Maximum = 6 A high score indicates a higher level of anxiety.
Assess patients' depression levels compared to a control group.
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 1. = Several days 2. = More than half the days 3. = Almost every day Total score: Minimum = 0, Maximum = 6 A high score indicates a higher level of depressive symptoms
Assess patients' quality of life in comparison with a control group.
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 1. = A little 2. = A lot 3. = Very much Total score: Minimum = 0, Maximum = 30 A high score indicates a greater impact of the skin condition on quality of life
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Brest
Lead sponsor
University of Graz
Collaborator
Justus-Liebig University Gießen Medical Center
Collaborator
Szeged University
Collaborator
University of Skopje
Collaborator
University of Amsterdam
Collaborator
University of Stavanger
Collaborator
University of Bergen
Collaborator
Wroclaw Medical University
Collaborator
University of Rzeszow
Collaborator
Universidade do Algarve
Collaborator
Universidad de Zaragoza
Collaborator
University of La Laguna
Collaborator
Malmö University
Collaborator
Lund University
Collaborator
Karolinska Institutet
Collaborator
Sisli Hamidiye Etfal Training and Research Hospital
Collaborator
Cardiff University
Collaborator
University Hospital Muenster
Collaborator
Leiden University Medical Center
Collaborator
The Royal London Hospital, UK
Collaborator
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