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Completed

NCT Number: NCT06324695

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HautKompass

Behavioral

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).

Primary outcomes

  1. 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)

    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 outcomes

  1. Changes from baseline to post-intervention and follow-up in generic quality of life

    Time frame: 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.

  2. Changes from baseline to post-intervention and follow-up in skin-generic quality of life

    Time frame: 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.

  3. Changes from baseline to post-intervention and follow-up in depression

    Time frame: 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.

  4. Changes from baseline to post-intervention and follow-up in anxiety

    Time frame: 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.

  5. Changes from baseline to post-intervention and follow-up in suicidal ideation

    Time frame: 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.

  6. Feasibility of the HautKompass online program

    Time frame: 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.

  7. Feasibility of the HautKompass online program - dropouts

    Time frame: continuously tracked during intervention

    Measured through dropout rate.

  8. User satisfaction with the HautKompass online program

    Time frame: 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.

  9. Acceptability of the HautKompass online program

    Time frame: 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.

Other outcomes

  1. Changes from baseline to post-intervention and follow-up in illness identity

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

    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.

  2. Changes from baseline to post-intervention and follow-up in avoidance and acceptance coping

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

    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.

  3. Changes from baseline to post-intervention and follow-up in generic body image/ appearance concerns

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

    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.

  4. Changes from baseline to post-intervention and follow-up in cutaneous body image

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

    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.

  5. Changes from baseline to post-intervention and follow-up in self-compassion

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

    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.

  6. Session Feedback

    Time frame: At the end of each session of the program

    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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Acronym: DEVISE

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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