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.
調査の概要
状態
条件
介入・治療
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Emilie Dr BRENAUT, Dermatologist
- 電話番号：+33 2 98 22 35 90
- メール：emilie.brenaut@chu-brest.fr
研究場所
-
-
-
Brest、フランス、29200
- CHU Brest
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Case group (Patients with skin disease)
Patients with skin conditions (inflammatory, autoimmune, cancerous, and genetic skin diseases)
|
|
|
他の：Control group (people without skin conditions)
People without skin conditions
|
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To assess adaptive coping in patients with skin conditions and compare them to those of a control group consisting of individuals with healthy skin.
時間枠：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:
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.
時間枠：1 day
|
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.
時間枠：1 day
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assess patients' sleep compared to controls.
時間枠：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
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.
時間枠：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
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.
時間枠：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
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.
時間枠：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
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.
時間枠：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
Total score: Minimum = 0, Maximum = 25 A lower score indicates better skin well-being. |
1 day
|
|
Assessing the impact of dermatosis on the partner
時間枠：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
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
|
協力者と研究者
協力者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 29BRC25.0465
- 2025-A02798-41 (その他の識別子：Agence Nationale de Sécurité du Médicament et des produits de santé)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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