{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T18:41:54Z","timestamp":1791830514854,"version":"4.3.4"},"reference-count":31,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T00:00:00Z","timestamp":1694044800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosdigitalhealth.org"],"crossmark-restriction":false},"short-container-title":["PLOS Digit Health"],"abstract":"<jats:p>Tinnitus, the phantom perception of sounds, generates distress and anxiety in those affected. Cognitive behavioral treatment approaches reproducibly help patients in managing chronic tinnitus. This study systematically evaluated the usefulness of a tinnitus app (with areas of attention and relaxation, mindfulness, acceptance, self-efficacy), which is prescribed for a total of nine months. One hundred eighty-seven participants with chronic tinnitus were equally randomized to an intervention arm that used a smartphone-based intervention -marketed as Kalmeda Tinnitus app-. and a control arm with delayed onset of treatment by 3 months. The first 3 months of a 9-months prescribed intervention have been analyzed as primary outcome. The Tinnitus Questionnaire (TQ) was used as primary endpoint to determine the reduction of tinnitus distress. Following intervention, there was a statistically significant and clinically relevant reduction of the TQ sum score in the intervention group compared to the control group (p&lt;0.001, Cohen\u2019s d effect size = 1.1). The secondary parameters, Patient Health Questionnaire-9 (PHQ9) and Perceived-Stress-Questionnaire (PSQ20) scores improved significantly in the intervention group whereas the Self Efficacy-Optimism-Pessimism short form (SWOP-K9) scores remained unchanged in both groups. Patients reported no treatment-related side effects. Taken together, use of this Tinnitus app lead to a significant decrease in tinnitus distress and a clinically relevant effect in the patients\u00b4 self-reported everyday management.<\/jats:p>","DOI":"10.1371\/journal.pdig.0000337","type":"journal-article","created":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T17:25:36Z","timestamp":1694107536000},"page":"e0000337","update-policy":"https:\/\/doi.org\/10.1371\/journal.pdig.corrections_policy","source":"Crossref","is-referenced-by-count":18,"title":["Randomized controlled trial of a smartphone-based cognitive behavioral therapy for chronic tinnitus"],"prefix":"10.1371","volume":"2","author":[{"given":"Uso","family":"Walter","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Pennig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanja","family":"Kottmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lothar","family":"Bleckmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1375-2418","authenticated-orcid":true,"given":"Kristina","family":"R\u00f6schmann-Doose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Winfried","family":"Schlee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2023,9,7]]},"reference":[{"key":"pdig.0000337.ref001","doi-asserted-by":"crossref","first-page":"100250","DOI":"10.1016\/j.lanepe.2021.100250","article-title":"Tinnitus prevalence in Europe: a multi-country cross-sectional population study","volume":"12","author":"R Biswas","year":"2022","journal-title":"Lancet Regional Health-Europe"},{"key":"pdig.0000337.ref002","doi-asserted-by":"crossref","first-page":"341","DOI":"10.3389\/fnhum.2016.00341","article-title":"Impact of multiple factors on the degree of tinnitus distress","volume":"10","author":"P Br\u00fcggemann","year":"2016","journal-title":"Front Hum Neurosci"},{"key":"pdig.0000337.ref003","doi-asserted-by":"crossref","first-page":"110693","DOI":"10.1016\/j.jpsychores.2021.110693","article-title":"Factors associated with Self Rated Health in persons with tinnitus from the general population","volume":"153","author":"OVG Wagenaar","year":"2022","journal-title":"J Psychosom Res"},{"key":"pdig.0000337.ref004","doi-asserted-by":"crossref","first-page":"621145","DOI":"10.3389\/fnins.2021.621145","article-title":"The neural mechanisms of tinnitus: a perspective from functional magnetic resonance imaging","volume":"15","author":"J Hu","year":"2021","journal-title":"Front Neurosci"},{"issue":"4","key":"pdig.0000337.ref005","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1192\/bjp.bp.113.142612","article-title":"Technological innovations in mental healthcare: harnessing the digital revolution","volume":"206","author":"C Hollis","year":"2015","journal-title":"Br JPsychiatry"},{"issue":"1","key":"pdig.0000337.ref006","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1007\/s00106-019-0633-7","article-title":"A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment","volume":"67","author":"R Cima","year":"2019","journal-title":"HNO"},{"issue":"3","key":"pdig.0000337.ref007","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1002\/wps.20442","article-title":"The third wave of cognitive behavioral therapy and the rise of process-based care","volume":"16","author":"SC Hayes","year":"2017","journal-title":"World psychiatry"},{"issue":"12","key":"pdig.0000337.ref008","doi-asserted-by":"crossref","first-page":"1028","DOI":"10.1017\/S0022215114002849","article-title":"Clinical efficacy of tinnitus retraining therapy and cognitive behavioural therapy in the treatment of subjective tinnitus: a systematic review","volume":"128","author":"R Grewal","year":"2014","journal-title":"J Laryngol Otol"},{"issue":"4","key":"pdig.0000337.ref009","doi-asserted-by":"crossref","first-page":"545","DOI":"10.1016\/j.cpr.2010.12.006","article-title":"A systematic review and meta-analysis of randomized controlled trials of cognitive\u2013behavioral therapy for tinnitus distress","volume":"31","author":"H Hesser","year":"2011","journal-title":"Clin Psychol Rev"},{"issue":"11","key":"pdig.0000337.ref010","doi-asserted-by":"crossref","first-page":"737","DOI":"10.1016\/j.brat.2011.08.001","article-title":"Acceptance and commitment therapy versus tinnitus retraining therapy in the treatment of tinnitus: a randomised controlled trial","volume":"49","author":"VZ Westin","year":"2011","journal-title":"Behav Res Ther"},{"issue":"1","key":"pdig.0000337.ref011","doi-asserted-by":"crossref","first-page":"e12530","DOI":"10.2196\/12530","article-title":"Internet-delivered acceptance and commitment therapy for anxiety treatment: systematic review","volume":"21","author":"J Kelson","year":"2019","journal-title":"J Med Internet Res"},{"issue":"41","key":"pdig.0000337.ref012","doi-asserted-by":"crossref","first-page":"e27509","DOI":"10.1097\/MD.0000000000027509","article-title":"Efficacy of sound therapy interventions for tinnitus management: A protocol for systematic review and network meta-analysis","volume":"100","author":"H Liu","year":"2021","journal-title":"Medicine"},{"key":"pdig.0000337.ref013","author":"H. Zenner","year":"2015","journal-title":"S3-Leitlinie 017\/064: Chronischer Tinnitus"},{"key":"pdig.0000337.ref014","article-title":"Tinnitus-Fragebogen:(TF); ein Instrument zur Erfassung von Belastung und Schweregrad bei Tinnitus; Handanweisung","author":"G Goebel","year":"1998","journal-title":"Hogrefe, Verlag f\u00fcr Psychologie"},{"key":"pdig.0000337.ref015","article-title":"A state-of-art review of digital technologies for the next generation of tinnitus therapeutics","volume":"3","author":"GD Searchfield","year":"2021","journal-title":"FrontDigit Health"},{"issue":"1","key":"pdig.0000337.ref016","article-title":"Cognitive behavioural therapy for tinnitus","author":"T Fuller","year":"2020","journal-title":"Cochrane Database Syst Rev"},{"issue":"1","key":"pdig.0000337.ref017","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/1477-7525-10-79","article-title":"Linking the Tinnitus Questionnaire and the subjective Clinical Global Impression: Which differences are clinically important?","volume":"10","author":"I Adamchic","year":"2012","journal-title":"Health Qual Life Outcomes"},{"issue":"2","key":"pdig.0000337.ref018","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1080\/14992027.2017.1384858","article-title":"Process evaluation of Internet-based cognitive behavioural therapy for adults with tinnitus in the context of a randomised control trial","volume":"57","author":"EW Beukes","year":"2018","journal-title":"IntJ Audiol"},{"issue":"1","key":"pdig.0000337.ref019","doi-asserted-by":"crossref","first-page":"73","DOI":"10.1016\/j.genhosppsych.2004.08.008","article-title":"Psychosocial and personality predictors of tinnitus-related distress","volume":"27","author":"M Langenbach","year":"2005","journal-title":"Gen Hosp Psychiatry"},{"issue":"8","key":"pdig.0000337.ref020","doi-asserted-by":"crossref","first-page":"e049384","DOI":"10.1136\/bmjopen-2021-049384","article-title":"Internet-based cognitive\u2013behavioural therapy for tinnitus: secondary analysis to examine predictors of outcomes","volume":"11","author":"H Rodrigo","year":"2021","journal-title":"BMJ open"},{"issue":"12","key":"pdig.0000337.ref021","doi-asserted-by":"crossref","first-page":"947","DOI":"10.1080\/14992027.2018.1514538","article-title":"Participants\u2019 experiences of an Internet-based cognitive behavioural therapy intervention for tinnitus","volume":"57","author":"EW Beukes","year":"2018","journal-title":"Int J Audiol"},{"key":"pdig.0000337.ref022","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1016\/bs.pbr.2021.01.028","article-title":"On the relationship between tinnitus distress, cognitive performance and aging","volume":"262","author":"P Brueggemann","year":"2021","journal-title":"Prog Brain Res"},{"issue":"4","key":"pdig.0000337.ref023","doi-asserted-by":"crossref","first-page":"378","DOI":"10.1016\/j.jpsychores.2010.12.006","article-title":"The effect of waiting: a meta-analysis of wait-list control groups in trials for tinnitus distress","volume":"70","author":"H Hesser","year":"2011","journal-title":"J Psychosom Res"},{"key":"pdig.0000337.ref024","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1016\/j.invent.2016.08.002","article-title":"Development and technical functionality of an Internet-based intervention for tinnitus in the UK","volume":"6","author":"EW Beukes","year":"2016","journal-title":"Internet Interv"},{"issue":"12","key":"pdig.0000337.ref025","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":"pdig.0000337.ref026","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1007\/7854_2020_213","article-title":"Psychosocial variables that predict chronic and disabling tinnitus: a systematic review","author":"M Kleinst\u00e4uber","year":"2020","journal-title":"Curr Top Behav Neurosci"},{"issue":"10","key":"pdig.0000337.ref027","first-page":"600","article-title":"Rapid assessment of tinnitus-related psychological distress using the Mini-TQ","volume":"43","author":"W Hiller","year":"2004","journal-title":"Int J Audiol"},{"issue":"4","key":"pdig.0000337.ref028","first-page":"171","article-title":"Screening for psychiatric disorders with the Patient Health Questionnaire (PHQ)","volume":"50","author":"K Grafe","year":"2004","journal-title":"Results from the German validation study. Diagnostica"},{"key":"pdig.0000337.ref029","unstructured":"FliegeH, Rose M, Arck P, Levenstein S, Klapp BF. PSQ: Perceived Stress Questionnaire [Verfahrensdokumentation aus PSYNDEX Tests-Nr. 9004426, PSQ20-Skalenberechnung, PSQ20-Fragebogen Englisch, Deutsch, Deutsch (letzte 2 Jahre), PSQ30-Skalenberechnung, PSQ30-Fragebogen Englisch, Franz\u00f6sisch, Deutsch, Italienisch, und Spanisch]. Leibniz-Zentrum f\u00fcr Psychologische Information und Dokumentation (ZPID). Elektronisches Testarchiv; 2009; 2889."},{"issue":"8","key":"pdig.0000337.ref030","first-page":"275","article-title":"Questionnaire of self-efficacy, optimism and pessimism: reconstruction, selection of items and validation of an instrument by means of examinations of clinical samples","volume":"49","author":"G Scholler","year":"1999","journal-title":"Psychother Psychosom Med Psychol"},{"key":"pdig.0000337.ref031","doi-asserted-by":"crossref","first-page":"92","DOI":"10.1186\/1471-2288-13-92","article-title":"A tutorial on sensitivity analyses in clinical trials: the what, why, when and how","volume":"13","author":"L Thaban","year":"2013","journal-title":"BMC Med Res Methodol"}],"container-title":["PLOS Digital Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pdig.0000337","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T17:25:53Z","timestamp":1694107553000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pdig.0000337"}},"subtitle":[],"editor":[{"given":"Nicole Yee-Key","family":"Li-Jessen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2023,9,7]]},"references-count":31,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2023,9,7]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pdig.0000337","relation":{},"ISSN":["2767-3170"],"issn-type":[{"value":"2767-3170","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,7]]}}}