ClinicalTrials.gg
CompletedNCT06027034Updated Jun 16, 2026

Effectiveness of a Digital Health Application for Psoriasis

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

Phase
Not applicable
Study type
Interventional
Enrollment
348
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 299 studies in Psoriasis with a site in Germany — 13 open to participants now, 30 under way, 15 of them phase 3. Psoriasis · Germany.

Enrollment
89th of 260
348 · median 195
Started
2023
with 14 others
No phase
7 of 299
none open now
Registered
269th of 299
by date

Among the 299 studies in Psoriasis with a site in Germany, this one is the 89th largest by enrollment of the 260 interventional ones that give a count, is one of 15 that started in 2023, is one of 7 with no phase, and was the 269th registered.

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 348 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Open to participants now

13 of the 299 studies in Psoriasis with a site in Germany are open now, in 12 countries. Each count lists the studies.

All 13 open studies →

Who these studies take

Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 299 studies in Psoriasis with a site in Germany, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Psoriasis

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
348 participants (actual)

Study arms

  • Experimental
    Online program for psoriasis (GAIA-PSO-01) + TAU

    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)

  • No intervention
    TAU

    Participants allocated to the control group will receive access to treatment as usual (TAU).

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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

07

Study locations

1 site
  • GAIA AG
    Hamburg, Free and Hanseatic City of Hamburg 22085, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2023 to primary completion in Dec 2024, 15 months.

Of 134 interventional studies with no phase under Psoriasis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2023
First posted
Sep 7, 2023
StartActual
Sep 4, 2023
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 11, 2025
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06027034
Lead sponsor
Gaia AG
Collaborators
University of Giessen, Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
Sep 7, 2023
Start date
Sep 4, 2023
Primary completion
Dec 31, 2024
Completion
Dec 11, 2025
Last update
Jun 16, 2026

Study contacts

Uwe Gieler, Prof. Dr.
principal investigator · University of Giessen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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