{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T22:34:57Z","timestamp":1784932497525,"version":"3.55.0"},"reference-count":48,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2025,7,18]],"date-time":"2025-07-18T00:00:00Z","timestamp":1752796800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Centre for Healthy Ageing & Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia","award":["TAP-K014265"],"award-info":[{"award-number":["TAP-K014265"]}]},{"DOI":"10.13039\/501100020624","name":"NIHR Nottingham Biomedical Research Centre","doi-asserted-by":"publisher","award":["NIHR203310"],"award-info":[{"award-number":["NIHR203310"]}],"id":[{"id":"10.13039\/501100020624","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec027\">\n<jats:title>Background<\/jats:title>\n<jats:p>Tinnitus, a phantom auditory perception, varies from mild awareness to intolerable sounds that can severely impact psychological well-being, sometimes leading to suicidal ideation. While its causality remains unclear, studies show a strong link between tinnitus severity and psychological distress. A manualized intervention developed in the United Kingdom for audiologists, using a low-intensity, psychologically informed approach, has been successfully trialed in Western populations. However, its feasibility in Asian settings, particularly in Malaysia with its diverse cultures, remains unknown.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec028\">\n<jats:title>Methods<\/jats:title>\n<jats:p>Phase I involves three steps: (a) translating the intervention manual into Malay, (b) systematically adapting its content for cultural relevance, and (c) piloting the intervention. Phase II is a 4-month randomized controlled feasibility trial involving chronic tinnitus patients (n\u2009=\u200920), stratified by severity and randomly assigned to either (a) the adapted intervention delivered by a trained provider or (b) standard care. Feasibility outcomes include a 10% recruitment rate among eligible patients, a 65% eligibility rate within the target population, and 80% retention. Primary outcomes assess tinnitus severity via the Tinnitus Functional Index, while secondary outcomes measure psychological distress using the Depression Anxiety Stress Scale-42. Assessments occur at baseline, post-intervention (1 month), and at a 3-month follow-up. At follow-up, semi-structured interviews guided by the Theoretical Framework of Acceptability will explore participants\u2019 perceptions of the intervention.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec029\">\n<jats:title>Discussion<\/jats:title>\n<jats:p>This feasibility trial evaluates the practicality and acceptability of a culturally adapted, audiologist-delivered psychological intervention for chronic tinnitus patients in Malaysia. Unlike direct translations, it incorporates systematic cultural adaptation to ensure relevance for the target population. Findings will inform the viability of a future large-scale trial and the potential for expanding psychologically informed tinnitus care in audiology settings.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec030\">\n<jats:title>Trial registration number<\/jats:title>\n<jats:p>ACTRN12624001048572<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0328348","type":"journal-article","created":{"date-parts":[[2025,7,18]],"date-time":"2025-07-18T17:47:57Z","timestamp":1752860877000},"page":"e0328348","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":1,"title":["A culturally adapted psychologically informed, audiologist-delivered, manualized intervention for chronic tinnitus patients in Malaysia: Protocol for a randomized controlled feasibility trial"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-0735-8201","authenticated-orcid":true,"given":"Mohamad Azmeer","family":"Sadali","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5734-0853","authenticated-orcid":true,"given":"Wan Syafira","family":"Ishak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahadir","family":"Ahmad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derek J.","family":"Hoare","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,7,18]]},"reference":[{"issue":"9","key":"pone.0328348.ref001","doi-asserted-by":"crossref","first-page":"888","DOI":"10.1001\/jamaneurol.2022.2189","article-title":"Global prevalence and incidence of tinnitus: a systematic review and meta-analysis","volume":"79","author":"CM Jarach","year":"2022","journal-title":"JAMA Neurol"},{"key":"pone.0328348.ref002","unstructured":"Kementerian Kesihatan Malaysia. Laporan Tahunan Perkhidmatan Pemulihan Perubatan (Audiologi). 2022."},{"issue":"8","key":"pone.0328348.ref003","doi-asserted-by":"crossref","first-page":"1129","DOI":"10.3390\/brainsci13081129","article-title":"The analogy between tinnitus and chronic pain: a phenomenological approach","volume":"13","author":"AJ Norena","year":"2023","journal-title":"Brain Sci"},{"key":"pone.0328348.ref004","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3389\/fauot.2023.1325137","article-title":"A critical review of established tinnitus patient-reported outcomes as measures of tinnitus severity and tinnitus distress and exemplar analysis of the Tinnitus Handicap Inventory as a formative or reflective measure","volume":"1","author":"NA Clarke","year":"2024","journal-title":"Front Audiol Otol"},{"issue":"7","key":"pone.0328348.ref005","first-page":"491","article-title":"Approach to tinnitus management","volume":"64","author":"V Wu","year":"2018","journal-title":"Can Fam 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Organization","year":"2016"},{"issue":"4","key":"pone.0328348.ref024","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1037\/a0016401","article-title":"Cultural adaptation of treatments: a resource for considering culture in evidence-based practice","volume":"40","author":"G Bernal","year":"2009","journal-title":"Professional Psychology"},{"issue":"3","key":"pone.0328348.ref025","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1080\/14992027.2017.1393565","article-title":"A good practice guide for translating and adapting hearing-related questionnaires for different languages and cultures","volume":"57","author":"DA Hall","year":"2018","journal-title":"Int J Audiol"},{"key":"pone.0328348.ref026","first-page":"1","article-title":"SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials","author":"AW Chan","year":"2024","journal-title":"BMJ"},{"key":"pone.0328348.ref027","author":"A Buchner","year":"2023"},{"issue":"12","key":"pone.0328348.ref028","doi-asserted-by":"crossref","first-page":"1126","DOI":"10.1001\/jamaoto.2018.2238","article-title":"Effectiveness of guided internet-based cognitive behavioral therapy vs face-to-face clinical care for treatment of tinnitus: a randomized clinical trial","volume":"144","author":"EW Beukes","year":"2018","journal-title":"JAMA Otolaryngol Head Neck Surg"},{"key":"pone.0328348.ref029","first-page":"282","article-title":"Montreal Cognitive Assessment (MoCA): concept and clinical review","volume-title":"Cognitive Aging and Dementia: A Clinical Manual for Assessment and Treatment","author":"P Julayanont","year":"2013"},{"issue":"3","key":"pone.0328348.ref030","doi-asserted-by":"crossref","first-page":"56","DOI":"10.11648\/j.cmr.20140303.11","article-title":"Validation of malay version of montreal cognitive assessment in patients with cognitive impairment","volume":"3","author":"W Kooi Cheah","year":"2014","journal-title":"Clin 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The role of hidden hearing loss in tinnitus: Insights from early markers of peripheral hearing damage. Preprint. 2021."},{"issue":"3","key":"pone.0328348.ref032","first-page":"383","article-title":"Psychometric normalization of a hyperacusis questionnaire","volume":"3","author":"S Khalfa","year":"2002","journal-title":"J Assoc Res Otolaryngol"},{"key":"pone.0328348.ref033","author":"GC Urbaniak","year":"2013"},{"key":"pone.0328348.ref034","article-title":"A Culturally adapted psychologically informed, audiologist-delivered, manualized intervention for chronic tinnitus patients in Malaysia v1","author":"M Azmeer Sadali","year":"2025","journal-title":"Springer Science and Business Media LLC"},{"issue":"9","key":"pone.0328348.ref035","doi-asserted-by":"crossref","first-page":"1700","DOI":"10.1097\/j.pain.0000000000002617","article-title":"A prospective, double-blind, pilot, randomized, controlled trial of an \u201cembodied\u201d virtual reality intervention for adults with low back pain","volume":"163","author":"C Eccleston","year":"2022","journal-title":"Pain"},{"issue":"1","key":"pone.0328348.ref036","doi-asserted-by":"crossref","first-page":"167","DOI":"10.1186\/s40814-020-00634-w","article-title":"Guidance for conducting feasibility and pilot studies for implementation trials","volume":"6","author":"N Pearson","year":"2020","journal-title":"Pilot Feasibility Stud"},{"issue":"2","key":"pone.0328348.ref037","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1097\/AUD.0b013e31822f67c0","article-title":"The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus","volume":"33","author":"MB Meikle","year":"2012","journal-title":"Ear Hear"},{"key":"pone.0328348.ref038","first-page":"1","article-title":"Validity and reliability of Tinnitus Functional Index (TFI) to malay language: a preliminary study","volume":"33","author":"A Anis Aqila","year":"2023","journal-title":"Kolok Prasiswazah Audiol"},{"issue":"2","key":"pone.0328348.ref039","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1037\/1040-3590.10.2.176","article-title":"Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample","volume":"10","author":"MM Antony","year":"1998","journal-title":"Psychological Assess"},{"issue":"1","key":"pone.0328348.ref040","first-page":"7","article-title":"Psychometric profile of Malaysian version of the depressive, anxiety and stress Scale 42-item (DASS-42)","volume":"1","author":"M Ramli","year":"2012","journal-title":"MJP Online Early"},{"issue":"3","key":"pone.0328348.ref041","doi-asserted-by":"crossref","first-page":"135","DOI":"10.2310\/7200.2006.017","article-title":"Multiple assessment in quality of life trials: how many questionnaires? How often should they be given?","volume":"4","author":"AJ Vickers","year":"2006","journal-title":"J Soc Integr Oncol"},{"issue":"1","key":"pone.0328348.ref042","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1186\/s12913-017-2031-8","article-title":"Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework","volume":"17","author":"M Sekhon","year":"2017","journal-title":"BMC Health Serv Res"},{"issue":"1","key":"pone.0328348.ref043","doi-asserted-by":"crossref","first-page":"279","DOI":"10.1186\/s12913-022-07577-3","article-title":"Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions","volume":"22","author":"M Sekhon","year":"2022","journal-title":"BMC Health Serv Res"},{"issue":"4","key":"pone.0328348.ref044","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1044\/2018_AJA-17-0096","article-title":"Effectiveness of audiologist-delivered cognitive behavioral therapy for tinnitus and hyperacusis rehabilitation: outcomes for patients treated in routine practice","volume":"27","author":"H Aazh","year":"2018","journal-title":"Am J Audiol"},{"issue":"2","key":"pone.0328348.ref045","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1191\/1478088706qp063oa","article-title":"Using thematic analysis in psychology","volume":"3","author":"V Braun","year":"2006","journal-title":"Qualitative Res Psychol"},{"key":"pone.0328348.ref046","first-page":"1","article-title":"The economics of mental health: With modern psychological therapy, mentally ill people can become more productive and more satisfied with life","author":"R Layard","year":"2017","journal-title":"IZA World Labor"},{"issue":"1","key":"pone.0328348.ref047","first-page":"1","article-title":"The effectiveness of mindfulness-based cognitive therapy in the management of tinnitus","volume":"26","author":"C Jariengprasert","year":"2022","journal-title":"Int Tinnitus J"},{"issue":"1","key":"pone.0328348.ref048","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.anl.2019.09.007","article-title":"Clinical practice guidelines for diagnosis and treatment of chronic tinnitus in Japan","volume":"47","author":"K Ogawa","year":"2020","journal-title":"Auris Nasus Larynx"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0328348","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,18]],"date-time":"2025-07-18T17:48:02Z","timestamp":1752860882000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0328348"}},"subtitle":[],"editor":[{"given":"Jeyasakthy","family":"Saniasiaya","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,7,18]]},"references-count":48,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2025,7,18]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0328348","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,18]]}}}