The Effects of Audio-Based Therapy on Anxiety in Psoriasis (PsOUND-PSO)

January 29, 2026 updated by: University of California, San Francisco
Anxiety in psoriasis is associated with impaired quality of life, and the prevalence of anxiety symptoms in psoriatic populations is approximately 34% and anxiety disorders up to 16%. Many experts recommend routine screening, referral, and interventions for anxiety in psoriasis; however, many barriers inhibit access to mental health resources and proper management. To our knowledge, there is a lack of easily accessible interventions that manage anxiety. Audio-based therapy offers convenient and effective interventions that show reduced anxiety in published, randomized studies and is a promising management for psoriasis patients. This study will evaluate the effects of audio therapy in patients with psoriasis and measure changes in overall symptoms.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Liao Lab at UCSF
        • Principal Investigator:
          • Wilson Liao, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Self-reported dermatologist-diagnosed psoriasis
  • GAD 2-Item Score ≥1 at screening
  • Ability to consent and complete pre- and post-intervention surveys.
  • Internet access and the ability to use a computer/smartphone with headphones for a single 23-30 minute session at home.

Exclusion Criteria:

  • Severe hearing impairment precluding headphone listening
  • Any condition requiring strict sound avoidance (such as seizure/epilepsy, major head trauma, severe sound-triggered migraine) that would make participation unsafe.
  • Other diagnoses that in the investigator's judgment preclude safe participation or interfere with anxiety or psoriasis evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Therapy
Participants listen to the iso-principle music with added auditory beat stimulation playlist for 23-30 minutes.
Behavioral: Music Therapy
Participants listen to the iso-principle music with added auditory beat stimulation playlist for 23-30 minutes.
Other Names:
  • Music
  • Complementary Therapies
  • Music therapy and auditory beat stimulation (ABS)
  • Complementary Therapy
  • Acoustic Stimulation
Sham Comparator: Pink Noise
Participants listen to the pink noise playlist for 23-30 minutes.
Behavioral: Pink Noise
Participants listen to the pink noise playlist for 23-30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Time Frame: From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.
The STICSA has good reliability and validity as a measure of state and trait cognitive and somatic anxiety. In this study, the post-intervention anxiety score is subtracted from the pre-intervention anxiety score, giving a measure of anxiety reduction. Greater anxiety reduction scores would indicate a better anxiety outcome.
From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood: Positive and Negative Affect Scale (PANAS)
Time Frame: From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.
The PANAS has demonstrated good reliability and validity, and has been widely used in numerous studies to assess mood. In this study, the post-intervention PANAS scores are subtracted from the pre-intervention PANAS scores, giving a measure of positive and negative mood changes. The scale generates two scores: 1) Positive affect (higher score indicates better mood outcome) and 2) Negative affect (higher score indicates worse mood outcome).
From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.
Itch: Itch Numeric Rating Score (INRS)
Time Frame: From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.
The INRS has good reliability and validity as a measure of 24-hour itch severity, though validity testing over more acute intervals remains limited. In this study, the post-intervention itch score is subtracted from the pre-intervention itch score, giving a measure of itch reduction. Greater itch reduction scores may indicate a better itch outcome.
From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Wilson Liao, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PsOUND-PSO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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