Skin DiseaseESDaP3NCT07640373
Coping Strategies, Loneliness, and Resilience in Patients With Dermatosis
A study testing Questionnaires in people with Skin Disease and Skin Disorder, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Disease, Skin Disorder, Skin Condition
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Skin Disease, Skin Disorder, Skin Condition, Inflammatory Skin Conditions, Autoimmune Skin Diseases, Cancerous Skin Conditions
- Being tested
- Questionnaires
- Keywords
- Adaptation strategies, loneliness, resilience
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Case group (Patients with skin disease) | Other | Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases) Receives: Other: Questionnaires |
| Control group (people without skin conditions) | Other | People without skin conditions Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- = I almost never do this
- = I do this sometimes
- = I do this often
- = 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
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:
- = Never
- = Rarely
- = Sometimes
- = Often
A high score indicates a high level of loneliness.
Measured: 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:
- = Strongly disagree
- = Disagree
- = Neither agree nor disagree
- = Agree
- = 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.
Measured: 1 day
Secondary outcomes (6)
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
- = Mild
- = Moderate
- = Severe
- = Very severe
Total score: Minimum = 0, Maximum = 28
A high score indicates a more severe form of insomnia.
Measured: 1 day
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
- = Several days
- = More than half the days
- = Almost every day
Total score: Minimum = 0, Maximum = 6
A high score indicates a higher level of anxiety.
Measured: 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
- = Several days
- = More than half the days
- = Almost every day
Total score: Minimum = 0, Maximum = 6
A high score indicates a higher level of depressive symptoms
Measured: 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
- = A little
- = A lot
- = Very much
Total score: Minimum = 0, Maximum = 30
A high score indicates a greater impact of the skin condition on quality of life
Measured: 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:
- All the time
- Most of the time
- More than half the time
- Less than half the time
- Sometimes
- Never
Total score: Minimum = 0, Maximum = 25
A lower score indicates better skin well-being.
Measured: 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
- = A little
- = 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case-control study
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640373
- Sponsor's protocol ID
- 29BRC25.0465
- Other IDs
- 2025-A02798-41
- Acronym
- ESDaP3
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Strategies, Loneliness, and Resilience in Patients With Dermatosis
- ClinicalTrials.gov ID
- NCT07640373
- Acronym / sponsor ID
- ESDaP3 / 29BRC25.0465
- Conditions
- Skin Disease, Skin Disorder, Skin Condition, Inflammatory Skin Conditions, Autoimmune Skin Diseases, Cancerous Skin Conditions
- Keywords
- Adaptation strategies, loneliness, resilience
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- 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 start
- Jul 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-control study
| Arm | Type | Receives |
|---|---|---|
| Case group (Patients with skin disease) | Other | Other: QuestionnairesPatients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases) |
| Control group (people without skin conditions) | Other | Other: QuestionnairesPeople without skin conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Case group (Patients with skin disease), Control group (people without skin conditions) |
Primary outcome
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
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.
Time frame: 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.
Time frame: 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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Skin Disease and Skin Disorder, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie Dr BRENAUT, Dermatologist (+33 2 98 22 35 90, emilie.brenaut@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.