Effectiveness of a Digital Health Application for Psoriasis
NCT ID: NCT06027034
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
348 participants
INTERVENTIONAL
2023-09-04
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
Online 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.
TAU
Participants allocated to the control group will receive access to treatment as usual (TAU).
No interventions assigned to this group
Interventions
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Online 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University of Giessen
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Gaia AG
INDUSTRY
Responsible Party
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Principal Investigators
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Uwe Gieler, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Giessen
Locations
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GAIA AG
Hamburg, City state of Hamburg, Germany
Countries
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Other Identifiers
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Psoriasis RCT 2023
Identifier Type: -
Identifier Source: org_study_id
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