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

DEVISE - Development and Evaluation of an Online Intervention to Reduce Self-stigma in People With Visible Chronic Skin Diseases: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Atopic Dermatitis; Vitiligo; Hidradenitis Suppurativa; Alopecia Areata
• Intervention / Treatment: Behavioral: HautKompass

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).

• Study Type: Interventional
• Enrollment (Actual): 298
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Adelsdorf, Germany, 91325
    • Deutscher Vitiligo-Bund e.V.
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie
  • Bochum, Germany, 44791
    • Universitätsklinikum der Ruhr-Universität Bochum (UKRUB), Klinik für Dermatologie, Venerologie und Allergologie
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf (UKE), Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
  • Hamburg, Germany, 20359
    • Deutscher Psoriasis Bund e.V. (DPB)
  • Hamburg, Germany, 22549
    • Hautarztpraxis Dr. Daniela Kasche
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie, Psoriasis-Zentrum-Kiel
  • Krefeld, Germany, 47701
    • Alopecia Areata Deutschland e.V.
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Hautklinik und Poliklinik
  • München, Germany, 80802
    • Technische Universität München, Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein
  • Münster, Germany, 48149
    • Universitätsklinikum Münster (UKM), Klinik für Hautkrankheiten - Allgemeine Dermatologie und Venerologie
  • Selters, Germany, 56242
    • Dermatologische Spezial- und Schwerpunktpraxis Dr. med. Ralph von Kiedrowski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HautKompass intervention; Participants in the intervention group will attend the self-guided 8-session online psychosocial intervention HautKompass.	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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline to post-intervention and follow-up in generic quality of life	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.	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	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.	Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
Changes from baseline to post-intervention and follow-up in depression	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.	Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
Changes from baseline to post-intervention and follow-up in anxiety	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.	Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
Changes from baseline to post-intervention and follow-up in suicidal ideation	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.	Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
Feasibility of the HautKompass online program	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.	continuously tracked during intervention
Feasibility of the HautKompass online program - dropouts	Measured through dropout rate.	continuously tracked during intervention
User satisfaction with the HautKompass online program	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.	Immediately post-intervention (t1)
Acceptability of the HautKompass online program	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.	Immediately post-intervention (t1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline to post-intervention and follow-up in illness identity	Evaluated with the Inclusion of Illness in the Self (IIS) scale. Respondents indicate in a single item the degree to which their illness is integrated into their self-concept. The higher the IIS score, the greater patients felt they internalized their illness.	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	Evaluated with the subscales avoidance (8 items) and positive rational acceptance (11 items) of the Body Image Coping Strategies Inventory (BICSI). The 19 items are answered in a Likert-type response scale ranging from 0 to 3, and an average score is calculated for each subscale, with higher scores indicating more frequent use of the specific coping strategy.	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	Evaluated with the Appearance Orientation Subscale of the Multidimensional Body-Self Relations Questionnaire (MBSRQ-AO). This subscale includes 2 items, to be answered on a 5-point Likert scale. The average score for the subscale is computed, with higher scores indicating more appearance concerns.	Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
Changes from baseline to post-intervention and follow-up in cutaneous body image	Evaluated with the Cutaneous Body Image Scale (CBIS), which comprises 7 items, to be rated on a response scale from 0 ("not at all") to 9 ("very markedly"). A composite score is derived from the mean ratings of the seven items, where a high score is indicative of greater satisfaction with cutaneous body image: score < 3 = severe dissatisfaction; 3-6 = moderate dissatisfaction; > 6 = mild to no dissatisfaction.	Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
Changes from baseline to post-intervention and follow-up in self-compassion	Evaluated with the short version of the Self-Compassion Scale (SCS), which includes 12 items, to be answered in a 5-point response scale ranging from 1 ("Almost never") to 5 ("Almost always"). Mean scores can be computed for six subscales - Self-Kindness, Self-Judgment (reversed scoring), Common Humanity, Isolation (reversed scoring), Mindfulness, and Over-identification (reversed scoring), as well as a total self-compassion score that results from the average of the six subscale mean scores, with higher scores indicating higher levels of self-compassion.	Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)
Session Feedback	Evaluated with an ad hoc questionnaire that comprises 3 questions tapping into whether the session just completed was interesting, easy to understand, and personally helpful. Respondents are asked to answer the questions on a 5-point Likert scale, where higher scores represent greater agreement.	At the end of each session of the program

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Rachel Sommer, Priv-Doz.Dr., Universitatsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): May 27, 2025

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive-behavioral therapy; Internet-based intervention; Self-compassion; Self-stigma; Visible chronic skin disease
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Infections; Skin Diseases, Papulosquamous; Hypotrichosis; Hair Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hypopigmentation; Pigmentation Disorders; Alopecia Areata; Hidradenitis Suppurativa; Hidradenitis; Alopecia; Vitiligo; Psoriasis; Dermatitis; Skin Diseases
• Other Study ID Numbers: 01GY2105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No