Development and EValuation of an Online Intervention to Reduce Self-Stigma in People With Visible Chronic Skin disEases

Last updated: June 4, 2025
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Completed

Phase

N/A

Condition

Eczema (Atopic Dermatitis)

Allergy

Acne Inversa

Treatment

HautKompass

Clinical Study ID

NCT06324695
01GY2105
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of psoriasis, atopic dermatitis, hidradenitis suppurativa,alopecia areata, or vitiligo;

  • Age ≥ 18 years;

  • Sufficient language skills (German) to follow the instructions and content of theintervention;

  • Access to a desktop/ laptop with internet connection;

  • Having signed an Informed Consent Form (ICF).

Exclusion

Exclusion Criteria:

  • Age < 18 years;

  • Lack of informed consent (ICF);

  • Patients that were treated in the last 12 months by a psychologist, psychotherapist,or psychiatrist for major depression, schizophrenia or other psychotic disorder,major bipolar disorder, major anxiety or obsessive-compulsive disorder,post-traumatic stress disorder, or major personality disorder.

Study Design

Total Participants: 298
Treatment Group(s): 1
Primary Treatment: HautKompass
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
May 27, 2025

Study Description

Background: Approximately 10 million people in Germany suffer from a chronic skin disease. Besides physical symptoms, the psychosocial burden for patients is high. A specific problem is stigmatization, which is still very burdensome for people with skin diseases. As a consequence of experienced discrimination, patients tend to accept and incorporate social prejudices, which impair self-esteem and self-efficacy, enhance isolation, and maintain a negatively self-reinforcing cycle. The World Health Organization has explicitly pointed out the importance of reducing stigma. While recent interventions for reducing external stigma in skin diseases have been developed and positively evaluated, evidence-based interventions on self-stigma in skin diseases are still lacking.

Objective: This project aims to develop and evaluate the effectiveness of an online intervention for patients with psoriasis, atopic dermatitis, hidradenitis suppurativa, alopecia areata, and vitiligo, to prevent and/or reduce self-stigma.

Methods: The evaluation of the online program will follow a randomized controlled design. 550 patients will be recruited through several participating centers across Germany and allocated to the intervention or the control group in a ratio of 1:1, with an equal distribution by diagnosis. Participants in the intervention group will attend a self-guided online program consisting of eight skin-generic modules (on average, 15-20 minutes per module, one module per week), combining educational content and cognitive-behavioral therapy-based exercises (e.g., cognitive restructuring of negative automatic thoughts; cultivating self-compassionate thinking and behavior). Participants in the control group will not attend an alternative program (waiting list) and will be offered the opportunity to attend the program after the follow-up phase. The primary outcome will be a reduction in self-stigma; the secondary outcome will be an improvement in psychosocial health, namely quality of life, depression, anxiety, and suicide ideation. These outcomes will be assessed by standardized patient-reported outcome measures at three time points: baseline (t0), immediately after the intervention (t1), and 6-month follow-up (t2).

Connect with a study center

  • Deutscher Vitiligo-Bund e.V.

    Adelsdorf, 91325
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Universitätsklinikum der Ruhr-Universität Bochum (UKRUB), Klinik für Dermatologie, Venerologie und Allergologie

    Bochum, 44791
    Germany

    Site Not Available

  • Deutscher Psoriasis Bund e.V. (DPB)

    Hamburg, 20359
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Daniela Kasche

    Hamburg, 22549
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf (UKE), Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie, Psoriasis-Zentrum-Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Alopecia Areata Deutschland e.V.

    Krefeld, 47701
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Hautklinik und Poliklinik

    Mainz, 55131
    Germany

    Site Not Available

  • Technische Universität München, Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein

    München, 80802
    Germany

    Site Not Available

  • Universitätsklinikum Münster (UKM), Klinik für Hautkrankheiten - Allgemeine Dermatologie und Venerologie

    Münster, 48149
    Germany

    Site Not Available

  • Dermatologische Spezial- und Schwerpunktpraxis Dr. med. Ralph von Kiedrowski

    Selters, 56242
    Germany

    Site Not Available

  • Privatpraxis Dr. med. Matthias Hoffmann

    Witten, 58453
    Germany

    Site Not Available

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