Development and EValuation of an Online Intervention to Reduce Self-Stigma in People with Visible Chronic Skin DisEases
- Conditions
- Hidradenitis SuppurativaPsoriasisVitiligoAlopecia AreataAtopic Dermatitis
- Interventions
- Behavioral: HautKompass
- Registration Number
- NCT06324695
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 298
- 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).
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HautKompass intervention HautKompass Participants in the intervention group will attend the self-guided 8-session online psychosocial intervention HautKompass.
- Primary Outcome Measures
Name Time Method Changes from baseline to post-intervention and follow-up in self-stigma Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2) 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.
- Secondary Outcome Measures
Name Time Method Changes from baseline to post-intervention and follow-up in depression Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2) Evaluated with the nine-item Patient Health Questionnaire (PHQ-9), which is a validated screening measure for diagnosing and monitoring depression. The response scale ranges from 0 ("not at all") to 3 ("nearly every day"); the sum score ranges from 0 to 27 and a cut-off point ≥ 10 has showed maximized sensitivity and specificity to detect major depression.
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) Evaluated with the EUROHIS-QOL 8-item index. The instrument includes 8 items assessing overall QOL, general health, energy, daily life activities, esteem, relationships, finances, and home environment, to be scored on a 5-point Likert scale. A total score is generated, with higher scores indicating better quality of life.
Changes from baseline to post-intervention and follow-up in suicidal ideation Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2) Evaluated with Paykel's Suicidal Feelings in the General Population Questionnaire, which is one of the most widely used measures of suicidal ideation in different populations, including medical settings. It comprises 5 questions about life-weariness, death wishes, and suicidal thoughts, plans and attempts, to be answered in a yes/no response scale. A "yes"-response to questions 3 to 5 indicates the presence of suicidal ideation.
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) Evaluated with the Dermatology Life Quality Index (DLQI), which includes 10 items, to be answered on a 4-point Likert scale ranging from 0 ("not at all"/ "not relevant") to 3 ("very much"). A total sum score ranging from 0 to 30 is computed, with higher scores indicating larger impairments. According to the Hongbo classification, DLQI scores \> 10 are considered as large or extremely large impairments on patients' life.
Changes from baseline to post-intervention and follow-up in anxiety Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2) Evaluated with the General Anxiety Disorder (GAD-7), which is a brief validated instrument to screen for anxiety disorders. It comprises seven items that represent core anxiety symptoms. The response scale ranges from 0 ("not at all") to 3 ("nearly every day"); the 7 items can be summed into a total score ranging from 0 to 21, with scores ≥ 10 indicating high likelihood of clinical anxiety disorders.
Feasibility of the HautKompass online program continuously tracked during intervention Measured through general statistics of website utilization (e.g., time spent on each session). Durations of individuals sessions of \> 45 minutes are considered not feasible for implementation.
Feasibility of the HautKompass online program - dropouts continuously tracked during intervention Measured through dropout rate.
User satisfaction with the HautKompass online program Immediately post-intervention (t1) Evaluated with the Client Satisfaction Questionnaire Adapted to Internet-Based Interventions (CSQ-I), which includes 8 questions on a Likert scale of 1 to 4, with higher scores indicating greater satisfaction.
Acceptability of the HautKompass online program Immediately post-intervention (t1) Evaluated with an ad hoc questionnaire that comprises 5 questions about the general acceptability of the website. Respondents are asked to answer the questions on a 4-point Likert scale, where higher scores represent higher acceptability.
Trial Locations
- Locations (12)
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Hautklinik und Poliklinik
🇩🇪Mainz, Germany
Deutscher Vitiligo-Bund e.V.
🇩🇪Adelsdorf, Germany
Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie
🇩🇪Bad Bentheim, Germany
Deutscher Psoriasis Bund e.V. (DPB)
🇩🇪Hamburg, Germany
Universitätsklinikum Münster (UKM), Klinik für Hautkrankheiten - Allgemeine Dermatologie und Venerologie
🇩🇪Münster, Germany
Dermatologische Spezial- und Schwerpunktpraxis Dr. med. Ralph von Kiedrowski
🇩🇪Selters, Germany
Universitätsklinikum der Ruhr-Universität Bochum (UKRUB), Klinik für Dermatologie, Venerologie und Allergologie
🇩🇪Bochum, Germany
Hautarztpraxis Dr. Daniela Kasche
🇩🇪Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE), Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
🇩🇪Hamburg, Germany
Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie, Psoriasis-Zentrum-Kiel
🇩🇪Kiel, Germany
Alopecia Areata Deutschland e.V.
🇩🇪Krefeld, Germany
Technische Universität München, Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein
🇩🇪München, Germany