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PsoriasisDEVISENCT06324695

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

A study testing HautKompass in people with Psoriasis and Alopecia Areata, run by Universitätsklinikum Hamburg-Eppendorf at 12 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HautKompass
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
12 sitesGermany
Study dates
1 Mar 2024to 27 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • Deutscher Vitiligo-Bund e.V.

    Adelsdorf, 91325

  • Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie

    Bad Bentheim, 48455

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

    Bochum, 44791

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

    Hamburg, 20246

  • Deutscher Psoriasis Bund e.V. (DPB)

    Hamburg, 20359

  • Hautarztpraxis Dr. Daniela Kasche

    Hamburg, 22549

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

    Kiel, 24105

  • Alopecia Areata Deutschland e.V.

    Krefeld, 47701

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

    Mainz, 55131

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

    München, 80802

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

    Münster, 48149

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

    Selters, 56242

Other trials in Germany

About this study

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

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.

Read the 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).

Being tested
HautKompass
Keywords
Self-compassion, Self-stigma, Cognitive-behavioral therapy, Internet-based intervention, Visible chronic skin disease
Medical subject headings
Psoriasis, Alopecia Areata, Hidradenitis Suppurativa, Vitiligo, Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HautKompassBehavioural

    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).

Study groups in NCT06324695
Study groupRoleWhat they receive
HautKompass interventionExperimentalParticipants in the intervention group will attend the self-guided 8-session online psychosocial intervention HautKompass.
Receives: Behavioral: HautKompass
Waiting listNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

Secondary outcomes (9)

  1. 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.

    Measured: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

  2. 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.

    Measured: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

  3. 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.

    Measured: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

  4. 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.

    Measured: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

  5. 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.

    Measured: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)

  6. 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.

    Measured: continuously tracked during intervention

  7. Feasibility of the HautKompass online program - dropouts

    Measured through dropout rate.

    Measured: continuously tracked during intervention

  8. 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.

    Measured: Immediately post-intervention (t1)

  9. 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.

    Measured: Immediately post-intervention (t1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study start1 Mar 2024
  3. Primary completion13 Dec 2024
  4. Study completion27 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06324695
Sponsor's protocol ID
01GY2105
Acronym
DEVISE
Status last verified
Jun 2025
First submitted
4 Oct 2023
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bessell A, Brough V, Clarke A, Harcourt D, Moss TP, Rumsey N. Evaluation of the effectiveness of Face IT, a computer-based psychosocial intervention for disfigurement-related distress. Psychol Health Med. 2012;17(5):565-77. doi: 10.1080/13548506.2011.647701. Epub 2012 Feb 7.

    PubMed 22313169

  • Durso LE, Latner JD. Understanding self-directed stigma: development of the weight bias internalization scale. Obesity (Silver Spring). 2008 Nov;16 Suppl 2:S80-6. doi: 10.1038/oby.2008.448.

    PubMed 18978768

  • Schmidt S, Muhlan H, Power M. The EUROHIS-QOL 8-item index: psychometric results of a cross-cultural field study. Eur J Public Health. 2006 Aug;16(4):420-8. doi: 10.1093/eurpub/cki155. Epub 2005 Sep 1.

    PubMed 16141303

  • Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

    PubMed 8033378

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8.

    PubMed 15183601

  • Paykel ES, Myers JK, Lindenthal JJ, Tanner J. Suicidal feelings in the general population: a prevalence study. Br J Psychiatry. 1974 May;124(0):460-9. doi: 10.1192/bjp.124.5.460. No abstract available.

    PubMed 4836376

  • Cash TF, Santos MT, Williams EF. Coping with body-image threats and challenges: validation of the Body Image Coping Strategies Inventory. J Psychosom Res. 2005 Feb;58(2):190-9. doi: 10.1016/j.jpsychores.2004.07.008.

    PubMed 15820848

  • Vossbeck-Elsebusch AN, Waldorf M, Legenbauer T, Bauer A, Cordes M, Vocks S. German version of the Multidimensional Body-Self Relations Questionnaire - Appearance Scales (MBSRQ-AS): confirmatory factor analysis and validation. Body Image. 2014 Jun;11(3):191-200. doi: 10.1016/j.bodyim.2014.02.002. Epub 2014 Mar 28.

    PubMed 24958652

  • Gupta MA, Gupta AK. Evaluation of cutaneous body image dissatisfaction in the dermatology patient. Clin Dermatol. 2013 Jan-Feb;31(1):72-9. doi: 10.1016/j.clindermatol.2011.11.010.

    PubMed 23245977

  • Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

    PubMed 21584907

  • Hilbert A, Baldofski S, Zenger M, Lowe B, Kersting A, Braehler E. Weight bias internalization scale: psychometric properties and population norms. PLoS One. 2014 Jan 29;9(1):e86303. doi: 10.1371/journal.pone.0086303. eCollection 2014.

    PubMed 24489713

  • Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.

    PubMed 18388841

  • Boss L, Lehr D, Reis D, Vis C, Riper H, Berking M, Ebert DD. Reliability and Validity of Assessing User Satisfaction With Web-Based Health Interventions. J Med Internet Res. 2016 Aug 31;18(8):e234. doi: 10.2196/jmir.5952.

    PubMed 27582341

Questions about this trial

What is this clinical trial studying?

A study testing HautKompass in people with Psoriasis and Alopecia Areata, run by Universitätsklinikum Hamburg-Eppendorf at 12 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline to post-intervention and follow-up in self-stigma (time frame: Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06324695, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.

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