Clinical trial NCT06324695: Development and EValuation of an Online Intervention to Reduce Self-Stigma in People With Visible Chronic Skin disEases
Official title: DEVISE - Development and Evaluation of an Online Intervention to Reduce Self-stigma in People With Visible Chronic Skin Diseases: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Alopecia Areata
Hidradenitis Suppurativa
Vitiligo
Atopic Dermatitis
Keywords: Self-compassion
Self-stigma
Cognitive-behavioral therapy
Internet-based intervention
Visible chronic skin disease
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2024-03-22
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Changes from baseline to post-intervention and follow-up in self-stigma
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
Secondary outcomes:
measure: Changes from baseline to post-intervention and follow-up in generic quality of life
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Changes from baseline to post-intervention and follow-up in skin-generic quality of life
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Changes from baseline to post-intervention and follow-up in depression
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Changes from baseline to post-intervention and follow-up in anxiety
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Changes from baseline to post-intervention and follow-up in suicidal ideation
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Feasibility of the HautKompass online program
timeFrame: continuously tracked during intervention
measure: Feasibility of the HautKompass online program - dropouts
timeFrame: continuously tracked during intervention
measure: User satisfaction with the HautKompass online program
timeFrame: Immediately post-intervention (t1)
measure: Acceptability of the HautKompass online program
timeFrame: Immediately post-intervention (t1)
Other outcomes:
measure: Changes from baseline to post-intervention and follow-up in illness identity
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Changes from baseline to post-intervention and follow-up in avoidance and acceptance coping
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Changes from baseline to post-intervention and follow-up in generic body image/ appearance concerns
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Changes from baseline to post-intervention and follow-up in cutaneous body image
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Changes from baseline to post-intervention and follow-up in self-compassion
timeFrame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
measure: Session Feedback
timeFrame: At the end of each session of the program
Locations:
city: Adelsdorf
country: Germany
facility: Deutscher Vitiligo-Bund e.V.
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie
city: Bochum
country: Germany
facility: Universitätsklinikum der Ruhr-Universität Bochum (UKRUB), Klinik für Dermatologie, Venerologie und Allergologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
city: Hamburg
country: Germany
facility: Deutscher Psoriasis Bund e.V. (DPB)
city: Hamburg
country: Germany
facility: Hautarztpraxis Dr. Daniela Kasche
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie, Psoriasis-Zentrum-Kiel
city: Krefeld
country: Germany
facility: Alopecia Areata Deutschland e.V.
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Hautklinik und Poliklinik
city: München
country: Germany
facility: Technische Universität München, Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein
city: Münster
country: Germany
facility: Universitätsklinikum Münster (UKM), Klinik für Hautkrankheiten - Allgemeine Dermatologie und Venerologie
city: Selters
country: Germany
facility: Dermatologische Spezial- und Schwerpunktpraxis Dr. med. Ralph von Kiedrowski
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Rachel Sommer, Priv-Doz.Dr.
role: PRINCIPAL_INVESTIGATOR
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