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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06324695
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universitätsklinikum Hamburg-Eppendorf
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rachel Sommer, Priv-Doz.Dr.
Principal Investigator Affiliation Universitätsklinikum Hamburg-Eppendorf
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Alopecia Areata, Hidradenitis Suppurativa, Vitiligo, Atopic Dermatitis
Additional Details

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).

Arms & Interventions

Arms

Experimental: HautKompass intervention

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

No Intervention: 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.

Interventions

Behavioral: - 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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Deutscher Vitiligo-Bund e.V., Adelsdorf, Germany

Status

Address

Deutscher Vitiligo-Bund e.V.

Adelsdorf, , 91325

Site Contact

Georg Pliszewski

mail@vitiligo-bund.de

040 23532891

Bad Bentheim, Germany

Status

Address

Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie

Bad Bentheim, , 48455

Site Contact

Athanasios Tsianakas, PD Dr.med.

info@fk-bentheim.de

05922 74-0

Bochum, Germany

Status

Address

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

Bochum, , 44791

Site Contact

Falk Bechara, Prof.Dr.med.

stephanie.pazia@kklbo.de

0234 509 6079

Hamburg, Germany

Status

Address

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

Hamburg, , 20246

Site Contact

Matthias Augustin, Prof.Dr.med.

m.augustin@uke.de

+49 (0) 40 7410 55428

Deutscher Psoriasis Bund e.V. (DPB), Hamburg, Germany

Status

Address

Deutscher Psoriasis Bund e.V. (DPB)

Hamburg, , 20359

Site Contact

Marius Grosser

info@psoriasis-bund.de

040 2233990

Hautarztpraxis Dr. Daniela Kasche, Hamburg, Germany

Status

Address

Hautarztpraxis Dr. Daniela Kasche

Hamburg, , 22549

Site Contact

Daniela Kasche, Dr. med.

praxis@dr-kasche.de

040 866 47 77 00

Kiel, Germany

Status

Address

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

Kiel, , 24105

Site Contact

Sascha Gerdes, Prof.Dr.med.

ssievers@dermatology.uni-kiel.de

0431 500 21102

Alopecia Areata Deutschland e.V., Krefeld, Germany

Status

Address

Alopecia Areata Deutschland e.V.

Krefeld, , 47701

Site Contact

Claudia Stenders

info@kreisrunderhaarausfall.de

02151 786006

Mainz, Germany

Status

Address

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

Mainz, , 55131

Site Contact

Petra Staubach-Renz, Prof.Dr.med.

petra.staubach@unimedizin-mainz.de

06131 175244 #175732

München, Germany

Status

Address

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

München, , 80802

Site Contact

Alexander Zink, PD Dr.med.

alexander.zink@tum.de

089 4140 3038

Münster, Germany

Status

Address

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

Münster, , 48149

Site Contact

Sonja Ständer, Prof.Dr.med.

sonja.staender@ukmuenster.de

0251 8357458

Selters, Germany

Status

Address

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

Selters, , 56242

Site Contact

Ralph von Kiedrowski, Dr. med.

dr.vonkiedrowski@cmss-selters.de

02626 900775

Privatpraxis Dr. med. Matthias Hoffmann, Witten, Germany

Status

Address

Privatpraxis Dr. med. Matthias Hoffmann

Witten, , 58453

Site Contact

Matthias Hoffmann, Dr. med.

service@hautarzt-dr-hoffmann.de

02302 56060

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.