[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07390487":3,"trial-entities:NCT07390487":129,"trial-summary:NCT07390487":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":45,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":59,"std_ages":71,"locations":74,"central_contacts":93,"overall_officials":95,"references":97,"see_also_links":128},"NCT07390487","PsOUND-PSO","The Effects of Audio-Based Therapy on Anxiety in Psoriasis","RECRUITING","2027-12","2026-07","2026-07-23","2026-02-01","University of California, San Francisco","OTHER",false,"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.",null,[18,19],"Psoriasis (PsO)","Anxiety",[21,22,23],"Surveys and Questionnaires","Acoustic Stimulation","Complementary Therapies","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},120,"ESTIMATED",[32,41],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BEHAVIORAL","Music Therapy","Participants listen to the iso-principle music with added auditory beat stimulation playlist for 23-30 minutes.",[34],[38,39,40,23,22],"Music therapy and auditory beat stimulation (ABS)","Music","Complementary Therapy",{"type":33,"name":42,"description":43,"armGroupLabels":44},"Pink Noise","Participants listen to the pink noise playlist for 23-30 minutes.",[42],[46],{"measure":47,"description":48,"timeFrame":49},"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.",[51,54],{"measure":52,"description":53,"timeFrame":49},"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).",{"measure":55,"description":56,"timeFrame":49},"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.","ALL","18 Years",{"inclusion":60,"exclusion":66,"raw_text":70},[61,62,63,64,65],"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\u002Fsmartphone with headphones for a single 23-30 minute session at home.",[67,68,69],"Severe hearing impairment precluding headphone listening","Any condition requiring strict sound avoidance (such as seizure\u002Fepilepsy, 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.","Inclusion Criteria:\n\n* Age ≥18 years\n* Self-reported dermatologist-diagnosed psoriasis\n* GAD 2-Item Score ≥1 at screening\n* Ability to consent and complete pre- and post-intervention surveys.\n* Internet access and the ability to use a computer\u002Fsmartphone with headphones for a single 23-30 minute session at home.\n\nExclusion Criteria:\n\n* Severe hearing impairment precluding headphone listening\n* Any condition requiring strict sound avoidance (such as seizure\u002Fepilepsy, major head trauma, severe sound-triggered migraine) that would make participation unsafe.\n* Other diagnoses that in the investigator's judgment preclude safe participation or interfere with anxiety or psoriasis evaluation.",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"status":7,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":90},"Liao Lab at UCSF","San Francisco","California","94115","United States",[82,87],{"name":83,"role":84,"phone":85,"email":86},"Amélie Spangenberg, Psoriasis Clinical Research Fellow, MBBS","CONTACT","415-944-7618","amelie.spangenberg@ucsf.edu",{"name":88,"role":89},"Wilson Liao, MD","PRINCIPAL_INVESTIGATOR",{"lat":91,"lon":92},37.77493,-122.41942,[94],{"name":83,"role":84,"phone":85,"email":86},[96],{"name":88,"affiliation":12,"role":89},[98,102,105,108,111,114,117,120,123,125],{"pmid":99,"type":100,"citation":101},"33888321","BACKGROUND","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\u002Fj.jid.2021.02.743. Epub 2021 Apr 19.",{"pmid":103,"type":100,"citation":104},"3397865","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\u002F\u002F0022-3514.54.6.1063.",{"pmid":106,"type":100,"citation":107},"37208459","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\u002Fs00403-023-02634-1. Epub 2023 May 19.",{"pmid":109,"type":100,"citation":110},"35263341","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\u002Fjournal.pone.0259312. eCollection 2022.",{"pmid":112,"type":100,"citation":113},"35604236","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\u002Factadv.v102.1386.",{"pmid":115,"type":100,"citation":116},"35101785","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\u002Fj.genhosppsych.2022.01.006. Epub 2022 Jan 25.",{"pmid":118,"type":100,"citation":119},"18085930","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\u002F1040-3590.19.4.369.",{"pmid":121,"type":100,"citation":122},"22170091","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\u002F00015555-1246.",{"type":100,"citation":124},"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.",{"pmid":126,"type":100,"citation":127},"20954057","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\u002F00223891.2010.513295.",[],{"nct_id":4,"conditions":130,"biomarkers":132},[131],"Psoriasis",[],{"nct_id":4,"found":134,"summary":135,"prompt_version":145},true,{"design":136,"status":137,"heading":138,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This study plans to enroll 120 participants to test two different audio interventions: Music Therapy and Pink Noise.","completed","Audio-Based Therapy for Anxiety in Psoriasis","This study is exploring whether listening to specific audio can help reduce anxiety for people with psoriasis (a skin condition). We are testing two types of audio: \"Music Therapy\" (music with added auditory beat stimulation) and \"Pink Noise.\" You might be able to join if you are 18 or older, have psoriasis diagnosed by a dermatologist, and have some anxiety symptoms (a GAD 2-Item Score of 1 or higher). The main goal is to see if these audio interventions can improve your anxiety symptoms, which will be measured right before and after a single 30-minute session. We plan to enroll 120 people, but the current status of the study is unclear.","Anxiety is measured from the pre-intervention survey to the post-intervention survey, approximately 30 minutes later.",111,"You would participate in a single 23-30 minute session at home, using a computer\u002Fsmartphone with headphones, and complete surveys before and after.","Not stated in the trial record.",[34,42],"v2"]