Coping Strategies, Loneliness, and Resilience in Patients With Dermatosis (ESDaP3)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Condition; Skin Disease; Skin Disorder; Inflammatory Skin Conditions; Autoimmune Skin Diseases; Cancerous Skin Conditions; Genetic Skin Conditions
• Intervention / Treatment: Other: Questionnaires

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 Type: Interventional
• Enrollment (Estimated): 375
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie Dr BRENAUT, Dermatologist; Phone Number: +33 2 98 22 35 90; Email: emilie.brenaut@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Chu Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Case group (Patients with skin disease); Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases)	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
Other: Control group (people without skin conditions); People without skin conditions	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: = 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	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.	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.	1 day

Secondary Outcome Measures

Outcome Measure	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; = Mild; = Moderate; = Severe; = Very severe Total score: Minimum = 0, Maximum = 28 A high score indicates a more severe form of insomnia.	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.	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	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	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; 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.	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.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Cardiff University; Karolinska Institutet; Lund University; University of Bergen; University Hospital Muenster; University of Amsterdam; Leiden University Medical Center; Sisli Hamidiye Etfal Training and Research Hospital; Universidad de Zaragoza; Wroclaw Medical University; Szeged University; University of Skopje; University of Rzeszow; Malmö University; University of La Laguna; University of Graz; University of Stavanger; Universidade do Algarve; Justus-Liebig University Gießen Medical Center; The Royal London Hospital, UK

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: resilience; loneliness; Adaptation strategies
• Additional Relevant MeSH Terms: Skin and Connective Tissue Diseases; Skin Diseases; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 29BRC25.0465; 2025-A02798-41 (Other Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No