Coping Strategies, Loneliness, and Resilience in Patients With Dermatosis

NCT07640373 | Not Yet Recruiting

• 2 other identifiers: 29BRC25.04652025-A02798-41
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Disease; Skin Disorder; Skin Condition; Autoimmune Skin Diseases; Cancerous Skin Conditions; Genetic Skin Conditions; Inflammatory Skin Conditions

Keywords

Adaptation strategies; loneliness; resilience

Outcome Measures

Primary Outcomes (3)

• 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

  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: 1. = Never 2. = Rarely 3. = Sometimes 4. = 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: 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.

  1 day

Secondary Outcomes (6)

• Assess patients' sleep compared to controls.

  1 day

• Assess patients' anxiety levels compared to controls.

  1 day

• Assess patients' depression levels compared to a control group.

  1 day

• Assess patients' quality of life in comparison with a control group.

  1 day

• Assess patients' well-being in comparison with a control group.

  1 day

Study Arms (2)

Case group (Patients with skin disease)

OTHER

Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases)

Other: Questionnaires

Control group (people without skin conditions)

OTHER

People without skin conditions

Other: Questionnaires

Interventions

Questionnaires OTHER

* 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

Case group (Patients with skin disease); Control group (people without skin conditions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead
• 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

Study Sites (1)

CHU Brest

Brest, 29200, France

Location

MeSH Terms

Conditions

Skin Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Emilie Dr BRENAUT, Dermatologist

CONTACT

+33 2 98 22 35 90; emilie.brenaut@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-control study

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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.

Locations

FR (1)