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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02798-41 | Other Identifier | Agence Nationale de Sécurité du Médicament et des produits de santé |
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| Name | Class |
|---|---|
| University of Graz | OTHER |
| Justus-Liebig University Gießen Medical Center | UNKNOWN |
| Szeged University | OTHER |
| University of Skopje |
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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.
At the time of enrollment, the following data will be collected:
Self-report questionnaires:
The estimated time to complete the questionnaires is 20 minutes; this will also be the duration of participation in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group (Patients with skin disease) | Other | Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases) |
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| Control group (people without skin conditions) | Other | People without skin conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
The analysis is conducted by subscale (each strategy), with scores ranging from 2 to 8. The interpretation depends on the coping strategy being measured:
| 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. | 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 |
| 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:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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
Total score: Minimum = 0, Maximum = 28 A high score indicates a more severe form of insomnia. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Dr BRENAUT, Dermatologist | Contact | +33 2 98 22 35 90 | emilie.brenaut@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | 29200 | France |
All collected data that underlie results in a publication
Data will be available beginning three years and ending fifteen years following the final study report completion
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| OTHER |
| University of Amsterdam | OTHER |
| University of Stavanger | OTHER |
| University of Bergen | OTHER |
| Wroclaw Medical University | OTHER |
| University of Rzeszow | OTHER |
| Universidade do Algarve | OTHER |
| Universidad de Zaragoza | OTHER |
| University of La Laguna | OTHER |
| Malmö University | OTHER |
| Lund University | OTHER |
| Karolinska Institutet | OTHER |
| Sisli Hamidiye Etfal Training and Research Hospital | OTHER |
| Cardiff University | OTHER |
| University Hospital Muenster | OTHER |
| Leiden University Medical Center | OTHER |
| The Royal London Hospital, UK | UNKNOWN |
Case-control study
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| 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
Total score: Minimum = 0, Maximum = 6 A high score indicates a higher level of anxiety. |
| 1 day |
| 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
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. | 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 |
| Assess patients' well-being in comparison with a control group. | 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 |
| Assessing the impact of dermatosis on the partner | 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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |