DEVISE - Development and Evaluation of an Online Intervention to Reduce Self-stigma in People With Visible Chronic Skin Diseases: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 24
- 主要终点
- Changes from baseline to post-intervention and follow-up in self-stigma
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Changes from baseline to post-intervention and follow-up in self-stigma
时间窗: 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.
次要结局
- Changes from baseline to post-intervention and follow-up in depression(Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2))
- 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))
- Changes from baseline to post-intervention and follow-up in suicidal ideation(Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2))
- Feasibility of the HautKompass online program(continuously tracked during intervention)
- 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))
- Changes from baseline to post-intervention and follow-up in anxiety(Baseline (t0), immediately post-intervention (t1), 6-months follow-up (t2))
- Feasibility of the HautKompass online program - dropouts(continuously tracked during intervention)
- User satisfaction with the HautKompass online program(Immediately post-intervention (t1))
- Acceptability of the HautKompass online program(Immediately post-intervention (t1))