Psoriasis
Conditions
Brief summary
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.
Interventions
BEHAVIORALOnline program for psoriasis (GAIA-PSO-01)
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.
Sponsors
Gaia AG
University of Giessen
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | 3 months | Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Severity | 3 months, 6 months, 12 months | Total score of the Self-Administered Psoriasis Area Severity Index (PASI). Total score ranging from 0-72; higher scores mean a worse outcome. |
| Depressive Symptoms | 3 months, 6 months, 12 months | Total score of the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean a worse outcome. |
| Body Surface Area (BSA) | 3 months, 6 months, 12 months | 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. |
| Health-Related Quality of Life | 6 months, 12 months | Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORUwe Gieler, Prof. Dr.
University of Giessen
Outcome results
None listed