Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-02-26 @ 7:47 PM
Study NCT ID:
NCT06324695
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2023-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and EValuation of an Online Intervention to Reduce Self-Stigma in People With Visible Chronic Skin disEases
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEVISE
Brief 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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: