The Effects of Audio-Based Therapy on Anxiety in Psoriasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Music Therapy
BehavioralParticipants listen to the iso-principle music with added auditory beat stimulation playlist for 23-30 minutes.
Pink Noise
BehavioralParticipants listen to the pink noise playlist for 23-30 minutes.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Music TherapyExperimental treatment 1 intervention
Group B: Pink NoiseSham comparator 1 intervention
Trial outcomes
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.
Time frame
From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.Secondary outcomes
1
Mood: Positive and Negative Affect Scale (PANAS)
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).
Time frame
From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.2
Itch: Itch Numeric Rating Score (INRS)
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.
Time frame
From the pre-intervention survey to the post-intervention survey, approximately 30 minutes.Sponsors and contacts
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Source ClinicalTrials.gov