protocolSection identificationModule nctId: NCT06324695, orgStudyIdInfo id: 01GY2105, briefTitle: Development and EValuation of an Online Intervention to Reduce Self-Stigma in People With Visible Chronic Skin disEases, acronym: DEVISE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Universitätsklinikum Hamburg-Eppendorf, class: OTHER, collaborators name: German Federal Ministry of Education and Research, descriptionModule briefSummary: This project aims to develop and evaluate an online intervention to prevent and/or reduce self-stigma in German patients with visible chronic skin diseases. Evaluation of the intervention with regard to effectiveness and feasibility will follow an open-label randomized controlled design with 550 patients in total. The results of the program are expected to provide new insights and markedly extended knowledge on the mechanisms of self-stigma in chronic skin conditions. The new online intervention can be used in routine care, aiming for better patient care in practice and, ultimately decreased extent of self-stigma, increased quality of life of patients, and decreased rates of depression, anxiety, and suicide ideation., conditionsModule conditions: Psoriasis, conditions: Alopecia Areata, conditions: Hidradenitis Suppurativa, conditions: Vitiligo, conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 550, type: ESTIMATED, armsInterventionsModule interventions name: HautKompass, outcomesModule primaryOutcomes measure: Changes from baseline to post-intervention and follow-up in self-stigma, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in generic quality of life, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in skin-generic quality of life, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in depression, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in anxiety, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in suicidal ideation, secondaryOutcomes measure: Feasibility of the HautKompass online program, secondaryOutcomes measure: Feasibility of the HautKompass online program - dropouts, secondaryOutcomes measure: User satisfaction with the HautKompass online program, secondaryOutcomes measure: Acceptability of the HautKompass online program, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in illness identity, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in avoidance and acceptance coping, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in generic body image/ appearance concerns, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in cutaneous body image, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in self-compassion, otherOutcomes measure: Session Feedback, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Deutscher Vitiligo-Bund e.V., city: Adelsdorf, zip: 91325, country: Germany, contacts name: Georg Pliszewski, role: CONTACT, phone: 040 23532891, email: mail@vitiligo-bund.de, geoPoint lat: 49.47022, lon: 10.68522, locations facility: Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, city: Bad Bentheim, zip: 48455, country: Germany, contacts name: Athanasios Tsianakas, PD Dr.med., role: CONTACT, phone: 05922 74-0, email: info@fk-bentheim.de, geoPoint lat: 52.30077, lon: 7.15767, locations facility: Universitätsklinikum der Ruhr-Universität Bochum (UKRUB), Klinik für Dermatologie, Venerologie und Allergologie, city: Bochum, zip: 44791, country: Germany, contacts name: Falk Bechara, Prof.Dr.med., role: CONTACT, phone: 0234 509 6079, email: stephanie.pazia@kklbo.de, geoPoint lat: 51.48165, lon: 7.21648, locations facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP), city: Hamburg, zip: 20246, country: Germany, contacts name: Matthias Augustin, Prof.Dr.med., role: CONTACT, phone: +49 (0) 40 7410 55428, email: m.augustin@uke.de, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Deutscher Psoriasis Bund e.V. (DPB), city: Hamburg, zip: 20359, country: Germany, contacts name: Marius Grosser, role: CONTACT, phone: 040 2233990, email: info@psoriasis-bund.de, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Hautarztpraxis Dr. Daniela Kasche, city: Hamburg, zip: 22549, country: Germany, contacts name: Daniela Kasche, Dr. med., role: CONTACT, phone: 040 866 47 77 00, email: praxis@dr-kasche.de, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie, Psoriasis-Zentrum-Kiel, city: Kiel, zip: 24105, country: Germany, contacts name: Sascha Gerdes, Prof.Dr.med., role: CONTACT, phone: 0431 500 21102, email: ssievers@dermatology.uni-kiel.de, geoPoint lat: 54.32133, lon: 10.13489, locations facility: Alopecia Areata Deutschland e.V., city: Krefeld, zip: 47701, country: Germany, contacts name: Claudia Stenders, role: CONTACT, phone: 02151 786006, email: info@kreisrunderhaarausfall.de, geoPoint lat: 51.33645, lon: 6.55382, locations facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Hautklinik und Poliklinik, city: Mainz, zip: 55131, country: Germany, contacts name: Petra Staubach-Renz, Prof.Dr.med., role: CONTACT, phone: 06131 175244, phoneExt: 175732, email: petra.staubach@unimedizin-mainz.de, geoPoint lat: 49.98419, lon: 8.2791, locations facility: Technische Universität München, Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, city: München, zip: 80802, country: Germany, contacts name: Alexander Zink, PD Dr.med., role: CONTACT, phone: 089 4140 3038, email: alexander.zink@tum.de, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Universitätsklinikum Münster (UKM), Klinik für Hautkrankheiten - Allgemeine Dermatologie und Venerologie, city: Münster, zip: 48149, country: Germany, contacts name: Sonja Ständer, Prof.Dr.med., role: CONTACT, phone: 0251 8357458, email: sonja.staender@ukmuenster.de, geoPoint lat: 51.96236, lon: 7.62571, locations facility: Dermatologische Spezial- und Schwerpunktpraxis Dr. med. Ralph von Kiedrowski, city: Selters, zip: 56242, country: Germany, contacts name: Ralph von Kiedrowski, Dr. med., role: CONTACT, phone: 02626 900775, email: dr.vonkiedrowski@cmss-selters.de, geoPoint lat: 50.51681, lon: 8.28953, locations facility: Privatpraxis Dr. med. Matthias Hoffmann, city: Witten, zip: 58453, country: Germany, contacts name: Matthias Hoffmann, Dr. med., role: CONTACT, phone: 02302 56060, email: service@hautarzt-dr-hoffmann.de, geoPoint lat: 51.44362, lon: 7.35258, hasResults: False