NCT07390487

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

January 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 29, 2026

Last Update Submit

January 29, 2026

Conditions

Keywords

Surveys and QuestionnairesAcoustic StimulationComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)

    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 Outcomes (2)

  • Mood: Positive and Negative Affect Scale (PANAS)

    From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.

  • Itch: Itch Numeric Rating Score (INRS)

    From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.

Study Arms (2)

Music Therapy

EXPERIMENTAL

Participants listen to the iso-principle music with added auditory beat stimulation playlist for 23-30 minutes.

Behavioral: Music Therapy

Pink Noise

SHAM COMPARATOR

Participants listen to the pink noise playlist for 23-30 minutes.

Behavioral: Pink Noise

Interventions

Music TherapyBEHAVIORAL

Participants listen to the iso-principle music with added auditory beat stimulation playlist for 23-30 minutes.

Also known as: Music therapy and auditory beat stimulation (ABS), Music, Complementary Therapy, Complementary Therapies, Acoustic Stimulation
Music Therapy
Pink NoiseBEHAVIORAL

Participants listen to the pink noise playlist for 23-30 minutes.

Pink Noise

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liao Lab at UCSF

San Francisco, California, 94115, United States

Location

Related Publications (10)

  • Yan D, Blauvelt A, Dey AK, Golpanian RS, Hwang ST, Mehta NN, Myers B, Shi ZR, Yosipovitch G, Bell S, Liao W. New Frontiers in Psoriatic Disease Research, Part II: Comorbidities and Targeted Therapies. J Invest Dermatol. 2021 Oct;141(10):2328-2337. doi: 10.1016/j.jid.2021.02.743. Epub 2021 Apr 19.

    PMID: 33888321BACKGROUND
  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PMID: 3397865BACKGROUND
  • Riew GJ, Kamal K, Hijaz B, Awh KC, Nambudiri VE. Clinical music interventions and music therapy in dermatology. Arch Dermatol Res. 2023 Nov;315(9):2485-2490. doi: 10.1007/s00403-023-02634-1. Epub 2023 May 19.

    PMID: 37208459BACKGROUND
  • Mallik A, Russo FA. The effects of music & auditory beat stimulation on anxiety: A randomized clinical trial. PLoS One. 2022 Mar 9;17(3):e0259312. doi: 10.1371/journal.pone.0259312. eCollection 2022.

    PMID: 35263341BACKGROUND
  • Jalenques I, Bourlot F, Martinez E, Pereira B, D'Incan M, Lauron S, Rondepierre F. Prevalence and Odds of Anxiety Disorders and Anxiety Symptoms in Children and Adults with Psoriasis: Systematic Review and Meta-analysis. Acta Derm Venereol. 2022 Aug 26;102:adv00769. doi: 10.2340/actadv.v102.1386.

    PMID: 35604236BACKGROUND
  • Hedemann TL, Liu X, Kang CN, Husain MI. Associations between psoriasis and mental illness: an update for clinicians. Gen Hosp Psychiatry. 2022 Mar-Apr;75:30-37. doi: 10.1016/j.genhosppsych.2022.01.006. Epub 2022 Jan 25.

    PMID: 35101785BACKGROUND
  • Gros DF, Antony MM, Simms LJ, McCabe RE. Psychometric properties of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA): comparison to the State-Trait Anxiety Inventory (STAI). Psychol Assess. 2007 Dec;19(4):369-81. doi: 10.1037/1040-3590.19.4.369.

    PMID: 18085930BACKGROUND
  • Phan NQ, Blome C, Fritz F, Gerss J, Reich A, Ebata T, Augustin M, Szepietowski JC, Stander S. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012 Sep;92(5):502-7. doi: 10.2340/00015555-1246.

    PMID: 22170091BACKGROUND
  • Gray EK, Watson, D. Assessing positive and negative affect via self-report. In: Coan JA, Allen, J.J.B., editor. Handbook of emotion elicitation and assessment. New York, NY: Oxford University Press; 2007.

    BACKGROUND
  • Bados A, Gomez-Benito J, Balaguer G. The state-trait anxiety inventory, trait version: does it really measure anxiety? J Pers Assess. 2010 Nov;92(6):560-7. doi: 10.1080/00223891.2010.513295.

    PMID: 20954057BACKGROUND

MeSH Terms

Conditions

PsoriasisAnxiety Disorders

Interventions

Music TherapyComplementary TherapiesAcoustic Stimulation

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesPhysical StimulationInvestigative Techniques

Study Officials

  • Wilson Liao, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Spangenberg, Psoriasis Clinical Research Fellow, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations