An interventional study of Online program for psoriasis (GAIA-PSO-01) in Psoriasis, sponsored by Gaia AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Gaia AG · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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)
Participants allocated to the control group will receive access to treatment as usual (TAU).
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.
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.
Time frame: 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months, 12 months
Patient Activation
Total score of the Patient Activation Measure-13 (PAM-13). Total score ranging from 0-100; higher scores mean a better outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months, 6 months, 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gaia AG