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OpenTrials
Completed

NCT Number: NCT06027034

Effectiveness of a Digital Health Application for Psoriasis

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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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GAIA AG

Hamburg, Free and Hanseatic City of Hamburg, 22085, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Health-Related Quality of Life

    Time frame: 3 months

    Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.

Secondary outcomes

  1. Psoriasis Severity

    Time frame: 3 months, 6 months, 12 months

    Total score of the Self-Administered Psoriasis Area Severity Index (PASI). Total score ranging from 0-72; higher scores mean a worse outcome.

  2. Depressive Symptoms

    Time frame: 3 months, 6 months, 12 months

    Total score of the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean a worse outcome.

  3. Body Surface Area (BSA)

    Time frame: 3 months, 6 months, 12 months

    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.

  4. Health-Related Quality of Life

    Time frame: 6 months, 12 months

    Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.

Other outcomes

  1. Patient Activation

    Time frame: 3 months, 6 months, 12 months

    Total score of the Patient Activation Measure-13 (PAM-13). Total score ranging from 0-100; higher scores mean a better outcome.

  2. Self-Esteem

    Time frame: 3 months, 6 months, 12 months

    Total score of the Rosenberg Self-Esteem Scale (RSE). Total score ranging from 0-30; higher scores mean a better outcome.

  3. Body Mass Index

    Time frame: 3 months, 6 months, 12 months

    Body mass index (BMI) is a simple measure of body fat based on height and weight. Higher values mean a worse outcome.

  4. Alcohol Consumption

    Time frame: 3 months, 6 months, 12 months

    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.

  5. Cigarette Smoking

    Time frame: 3 months, 6 months, 12 months

    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.

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • University of Giessen
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

Effectiveness of a Digital Health Application for Psoriasis: Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 7, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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