Effectiveness of a Digital Health Application for Psoriasis

Study Overview
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Brief Summary
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This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis. Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive 12-month-access to an online program for psoriasis in addition to treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy, pharmacotherapy, psychosocial therapy, etc.

Official Title
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Effectiveness of a Digital Health Application for Psoriasis: Randomized Controlled Trial

Conditions
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Psoriasis

Intervention / Treatment
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* Behavioral: Online program for psoriasis (GAIA-PSO-01)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Presence of psoriasis vulgaris or psoriatic arthritis Submission of a specialist medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses: Psoriasis vulgaris (L 40.0, L 40.7), Psoriatic arthritis (L40.5, M07.x) Impaired health-related quality of life (DLQI > 10) Consent to participate Sufficient understanding of the German language Exclusion Criteria: Presence of another subtype of psoriasis (pustular psoriasis, guttate psoriasis, inverse psoriasis, erythrodermic psoriasis, or drug-induced psoriasis) or psoriatic arthritis without skin involvement Presence of malignancies Presence of other chronic diseases with strong negative influence on quality of life Currently undergoing psychiatric treatment / current presence of a severe psychiatric diagnosis Insufficient language and/or IT skills

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online program for psoriasis (GAIA-PSO-01) + TAU<br>Participants allocated to the intervention group will receive access to an online program for psoriasis (GAIA-PSO-01) in addition to treatment as usual (TAU). | Behavioral: Online program for psoriasis (GAIA-PSO-01)<br>* The program to-be-tested (GAIA-PSO-01) is an interactive online program for independent use by users with psoriasis. It focuses on recognized treatment elements of cognitive behavioral therapy (CBT) and behavior change techniques.<br>|
| No Intervention: TAU<br>Participants allocated to the control group will receive access to treatment as usual (TAU). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life | Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Severity | Total score of the Self-Administered Psoriasis Area Severity Index (PASI). Total score ranging from 0-72; higher scores mean a worse outcome. | 3 months, 6 months, 12 months | 
| Depressive Symptoms | Total score of the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean a worse outcome. | 3 months, 6 months, 12 months | 
| Body Surface Area (BSA) | Body Surface Area (BSA) is a measure used to determine the extent of skin involvement in psoriasis. Total score ranging from 0-100; higher scores mean a worse outcome. | 3 months, 6 months, 12 months | 
| Health-Related Quality of Life | Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome. | 6 months, 12 months |