NCT06027034

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Sep 2023Dec 2026

First Submitted

Initial submission to the registry

August 31, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

August 31, 2023

Last Update Submit

August 18, 2025

Conditions

Psoriasis

Outcome Measures

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.

    3 months

Secondary Outcomes (4)

  • Psoriasis Severity

    3 months, 6 months, 12 months

  • Depressive Symptoms

    3 months, 6 months, 12 months

  • Body Surface Area (BSA)

    3 months, 6 months, 12 months

  • Health-Related Quality of Life

    6 months, 12 months

Other Outcomes (5)

  • Patient Activation

    3 months, 6 months, 12 months

  • Self-Esteem

    3 months, 6 months, 12 months

  • Body Mass Index

    3 months, 6 months, 12 months

  • +2 more other outcomes

Study Arms (2)

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).

Behavioral: Online program for psoriasis (GAIA-PSO-01)

TAU

NO INTERVENTION

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

Interventions

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GAIA AG

Hamburg, Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Uwe Gieler, Prof. Dr.

    University of Giessen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 7, 2023

Study Start

September 4, 2023

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 1, 2026

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)