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

NCT ID: NCT06324695

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-05-27

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.

Detailed 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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HautKompass intervention

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

Group Type: EXPERIMENTAL

HautKompass

Intervention Type: 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).

Waiting list

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HautKompass

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Sommer, Priv-Doz.Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Deutscher Vitiligo-Bund e.V.

Adelsdorf, , Germany

Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie

Bad Bentheim, , Germany

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

Bochum, , Germany

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

Hamburg, , Germany

Deutscher Psoriasis Bund e.V. (DPB)

Hamburg, , Germany

Hautarztpraxis Dr. Daniela Kasche

Hamburg, , Germany

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

Kiel, , Germany

Alopecia Areata Deutschland e.V.

Krefeld, , Germany

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

Mainz, , Germany

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

München, , Germany

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

Münster, , Germany

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

Selters, , Germany

Countries

Germany

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Other Identifiers

01GY2105

Identifier Type: -

Identifier Source: org_study_id