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| Name | Class |
|---|---|
| University of Giessen | OTHER |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online program for psoriasis (GAIA-PSO-01) + TAU | Experimental | 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). |
|
| TAU | No Intervention | Participants allocated to the control group will receive access to treatment as usual (TAU). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online program for psoriasis (GAIA-PSO-01) | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation | Total score of the Patient Activation Measure-13 (PAM-13). Total score ranging from 0-100; higher scores mean a better outcome. | 3 months, 6 months, 12 months |
| Self-Esteem | Total score of the Rosenberg Self-Esteem Scale (RSE). Total score ranging from 0-30; higher scores mean a better outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Gieler, Prof. Dr. | University of Giessen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GAIA AG | Hamburg | Free and Hanseatic City of Hamburg | 22085 | Germany |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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 |
| 3 months, 6 months, 12 months |
| Body Mass Index | Body mass index (BMI) is a simple measure of body fat based on height and weight. Higher values mean a worse outcome. | 3 months, 6 months, 12 months |
| Alcohol Consumption | Total score of the Alcohol use Disorders Identification Test - Consumption Items (AUDIT-C). Total score ranging from 0-12; higher scores mean a worse outcome. | 3 months, 6 months, 12 months |
| Cigarette Smoking | Cigarette smoking will be assessed with a single question 'How often do you smoke cigarettes?', with response options 'Never/rarely/sometimes/often/very often', coded from 0-4. Higher scores mean a worse outcome. | 3 months, 6 months, 12 months |