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

NCT06324695 | Completed

• 1 other identifier: 01GY2105
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Psoriasis; Alopecia Areata; Hidradenitis Suppurativa; Vitiligo; Atopic Dermatitis

Keywords

Self-compassion; Self-stigma; Cognitive-behavioral therapy; Internet-based intervention; Visible chronic skin disease

Outcome Measures

Primary Outcomes (1)

• Changes from baseline to post-intervention and follow-up in self-stigma

  Evaluated with the Weight Bias Internalization Scale (WBIS) - adapted for skin disease. The scale includes 10 items with a Likert-type response scale ranging from 1 to 7 and provides a total sum score ranging from 10 to 70, with higher scores indicating higher internalization of stigma and biases associated with own skin disease.

  Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

Secondary Outcomes (9)

• Changes from baseline to post-intervention and follow-up in generic quality of life

  Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

• Changes from baseline to post-intervention and follow-up in skin-generic quality of life

  Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

• Changes from baseline to post-intervention and follow-up in depression

  Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

• Changes from baseline to post-intervention and follow-up in anxiety

  Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

• Changes from baseline to post-intervention and follow-up in suicidal ideation

  Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

Other Outcomes (6)

• Changes from baseline to post-intervention and follow-up in illness identity

  Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

• Changes from baseline to post-intervention and follow-up in avoidance and acceptance coping

  Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

• Changes from baseline to post-intervention and follow-up in generic body image/ appearance concerns

  Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

Study Arms (2)

HautKompass intervention

EXPERIMENTAL

Participants in the intervention group will attend the self-guided 8-session online psychosocial intervention HautKompass.

Behavioral: HautKompass

Waiting list

NO INTERVENTION

Participants in the control group will not attend any psychosocial intervention during the course of the RCT (waiting list). They will be offered the opportunity to attend the HautKompass program after the follow-up phase.

Interventions

HautKompass BEHAVIORAL

The HautKompass program is a structured self-guided online psychosocial intervention designed to reduce self-stigma in people with visible chronic skin diseases. It combines educational content and practical exercises based on cognitive-behavioral therapy (CBT), namely cognitive restructuring of negative automatic thoughts and cultivating self-compassionate thinking and behavior. The program consists of eight skin-generic modules (on average, 15-20 minutes per module, one module per week).

HautKompass intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the intervention;
• Access to a desktop/ laptop with internet connection;
• Having signed an Informed Consent Form (ICF).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (12)

Deutscher Vitiligo-Bund e.V.

Adelsdorf, 91325, Germany

Location

Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie

Bad Bentheim, 48455, Germany

Location

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

Bochum, 44791, Germany

Location

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

Hamburg, 20246, Germany

Location

Deutscher Psoriasis Bund e.V. (DPB)

Hamburg, 20359, Germany

Location

Hautarztpraxis Dr. Daniela Kasche

Hamburg, 22549, Germany

Location

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

Kiel, 24105, Germany

Location

Alopecia Areata Deutschland e.V.

Krefeld, 47701, Germany

Location

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

Mainz, 55131, Germany

Location

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

München, 80802, Germany

Location

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

Münster, 48149, Germany

Location

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

Selters, 56242, Germany

Location

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MeSH Terms

Conditions

Psoriasis; Alopecia Areata; Hidradenitis Suppurativa; Vitiligo; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases; Hypopigmentation; Pigmentation Disorders; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rachel Sommer, Priv-Doz.Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: March 22, 2024
• Study Start: March 1, 2024
• Primary Completion: December 13, 2024
• Study Completion: May 27, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)