首页|Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: A randomised controlled trial

Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: A randomised controlled trial

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  • NSTL
  • Elsevier
Background: Up to 21% of adults will develop tinnitus, which is one of the most distressing and debilitating audiological problems. The absence of medical cures and standardised practice can lead to costly and prolonged treatment. We aimed to assess effectiveness of a stepped-care approach, based on cognitive behaviour therapy, compared with usual care in patients with varying tinnitus severity. Methods: In this randomised controlled trial, undertaken at the Adelante Department of Audiology and Communication (Hoensbroek, Netherlands), we enrolled previously untreated Dutch speakers (aged >18 years) who had a primary complaint of tinnitus but no health issues precluding participation. An independent research assistant randomly allocated patients by use of a computer-generated allocation sequence in a 1:1 ratio, stratified by tinnitus severity and hearing ability, in block sizes of four to receive specialised care of cognitive behaviour therapy with sound-focused tinnitus retraining therapy or usual care. Patients and assessors were masked to treatment assignment. Primary outcomes were health-related quality of life (assessed by the health utilities index score), tinnitus severity (tinnitus questionnaire score), and tinnitus impairment (tinnitus handicap inventory score), which were assessed before treatment and at 3 months, 8 months, and 12 months after randomisation. We used multilevel mixed regression analyses to assess outcomes in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00733044. Findings: Between September, 2007 and January, 2011, we enrolled and treated 492 (66%) of 741 screened patients. Compared with 247 patients assigned to usual care, 245 patients assigned to specialised care improved in healthrelated quality of life during a period of 12 months (between-group difference 0·059, 95% CI 0·025 to 0·094; effect size of Cohen's d=0·24; p=0·0009), and had decreased tinnitus severity (-8·062, -10·829 to -5·295; d=0·43; p<0·0001) and tinnitus impairment (-7·506, -10·661 to -4·352; d=0·45; p<0·0001). Treatment seemed effective irrespective of initial tinnitus severity, and we noted no adverse events in this trial. Interpretation: Specialised treatment of tinnitus based on cognitive behaviour therapy could be suitable for widespread implementation for patients with tinnitus of varying severity.

Maes,I.H.、Joore,M.A.、Scheyen,D.J.W.W.、ElRefaie,A.、Baguley,D.M.、Cima,R.F.F.、Anteunis,L.J.C.、VanBreukelen,G.J.P.、Vlaeyen,J.W.S.

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Department of Clinical Epidemiology and Medical Technology Assessment, University Hospital

Department of Audiology and Communication, Adelante, Hoensbroek, Netherlands

Centre for Hearing and Balance Studies, Bristol University, Bristol, United Kingdom

Department of Otolaryngology, Addenbrooke's Hospital, Cambridge, United Kingdom, Department of

Clinical Psychological Science, Maastricht University, PO Box 616, Maastricht 6200 MD, Netherlands

Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Maastricht

Department of Methodology and Statistics, Maastricht University, Maastricht, Netherlands

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2012

10.1016/S0140-6736(12)60469-3

The Lancet

The Lancet

ISSN：0140-6736
年,卷(期)：2012.379(9830)
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