Autoimmune Skin Diseases, Cancerous Skin Conditions, Genetic Skin Conditions, Inflammatory Skin Conditions, Skin Condition, Skin Disease, Skin Disorder
Conditions
Keywords
Adaptation strategies, loneliness, resilience
Brief summary
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
OTHERQuestionnaires
* 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
Sponsors
University Hospital, Brest
University of Graz
Justus-Liebig University Gießen Medical Center
Szeged University
University of Skopje
University of Amsterdam
University of Stavanger
University of Bergen
Wroclaw Medical University
University of Rzeszow
Universidade do Algarve
Universidad de Zaragoza
University of La Laguna
Malmö University
Lund University
Karolinska Institutet
Sisli Hamidiye Etfal Training and Research Hospital
Cardiff University
University Hospital Muenster
Leiden University Medical Center
The Royal London Hospital, UK
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Case-control study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin. | 1 day | 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. | 1 day | 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. | 1 day | 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
| Measure | Time frame | Description |
|---|---|---|
| Assess patients' sleep compared to controls. | 1 day | 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. | 1 day | 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. | 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 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. | 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 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 |
| Assess patients' well-being in comparison with a control group. | 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 1. Most of the time 2. More than half the time 3. Less than half the time 4. Sometimes 5. Never Total score: Minimum = 0, Maximum = 25 A lower score indicates better skin well-being. |
| Assessing the impact of dermatosis on the partner | 1 day | 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 1. = A little 2. = A lot Total score: Minimum = 0, Maximum = 32 A high score indicates a greater impact of the illness on the quality of life of family members. |
Countries
France
Contacts
CONTACTEmilie Dr BRENAUT, Dermatologist
Outcome results
None listed