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

Psoriasis Clinical Trial

— DEVISE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06324695
• Other study ID #: 01GY2105
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Rachel Sommer, Priv-Doz.Dr.
• Phone: +49 (0) 40 7410 24724
• Email: r.sommer[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Atopic Dermatitis
• Dermatitis
• Hidradenitis
• Hidradenitis Suppurativa
• Psoriasis
• Skin Diseases
• Vitiligo

Intervention

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).

Locations

Country	Name	City	State
Germany	Deutscher Vitiligo-Bund e.V.	Adelsdorf
Germany	Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie	Bad Bentheim
Germany	Universitätsklinikum der Ruhr-Universität Bochum (UKRUB), Klinik für Dermatologie, Venerologie und Allergologie	Bochum
Germany	Deutscher Psoriasis Bund e.V. (DPB)	Hamburg
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	Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Hautklinik und Poliklinik	Mainz
Germany	Technische Universität München, Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein	München
Germany	Universitätsklinikum Münster (UKM), Klinik für Hautkrankheiten - Allgemeine Dermatologie und Venerologie	Münster
Germany	Dermatologische Spezial- und Schwerpunktpraxis Dr. med. Ralph von Kiedrowski	Selters
Germany	Privatpraxis Dr. med. Matthias Hoffmann	Witten

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (45)

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Sommer R, Augustin M, Mrowietz U, Topp J, Schafer I, von Spreckelsen R. [Perception of stigmatization in people with psoriasis-qualitative analysis from the perspective of patients, relatives and healthcare professionals]. Hautarzt. 2019 Jul;70(7):520-526. doi: 10.1007/s00105-019-4411-y. German. — View Citation

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Topp J, Andrees V, Weinberger NA, Schafer I, Sommer R, Mrowietz U, Luck-Sikorski C, Augustin M. Strategies to reduce stigma related to visible chronic skin diseases: a systematic review. J Eur Acad Dermatol Venereol. 2019 Nov;33(11):2029-2038. doi: 10.1111/jdv.15734. Epub 2019 Aug 5. — View Citation

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Zander N, Sommer R, Schafer I, Reinert R, Kirsten N, Zyriax BC, Maul JT, Augustin M. Epidemiology and dermatological comorbidity of seborrhoeic dermatitis: population-based study in 161 269 employees. Br J Dermatol. 2019 Oct;181(4):743-748. doi: 10.1111/bjd.17826. Epub 2019 Jul 17. — View Citation

* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Feasibility of the HautKompass online program - dropouts	Measured through dropout rate.	continuously tracked during intervention
Secondary	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)
Secondary	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)