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Recruiting NCT07390487

The Effects of Audio-Based Therapy on Anxiety in Psoriasis

No phase Interventional Psoriasis (PsO) Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music Therapy, Pink Noise.
Who it may be relevant to
Registry conditions: Psoriasis (PsO), Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Music Therapy
    Participants listen to the iso-principle music with added auditory beat stimulation playlist for 23-30 minutes.
  • Behavioral Pink Noise
    Participants listen to the pink noise playlist for 23-30 minutes.

Primary outcome measures

  • 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.]
Secondary outcome measures (2)
  • Mood: Positive and Negative Affect Scale (PANAS) [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Liao Lab at UCSF — San Francisco

Publications

  • 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 33888321
  • 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 3397865
  • 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 37208459
  • 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 35263341
  • 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 35604236
  • 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 35101785
  • 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 18085930
  • 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 22170091

Identifiers

NCT: NCT07390487 · PsOUND-PSO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗