Does exposure-treatment decrease tinnitus-related fear, tinnitus-severity and recovery, when compared to a masking-therapy with use of personalised on-ear masking-devices, or vice versa? Can we identify different sub-groups of patients who benefit…
ID
Bron
Aandoening
Tinnitus, Cognitive behavioural treatment, Masking-therapy, fear-avoidance
Ondersteuning
P.O. Box 616 | 6200 MD Maastricht
E-mail: r.cima@maastrichtuniversity.nl
Adelante| Centre of expertise in Rehabilitation & Audiology
Zandbergsweg 111 | 6432 CC Hoensbroek
Tel (mob): +31 6 17 900 161| Fax: +31 45 5282348
Dossier nummer 016.165.105
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Tinnitus-disability: Tinnitus Handicap Inventory, (TFI; Tinnitus Functional Index)<br>
2. Tinnitus-severity: Tinnitus questionnaire (TQ)<br>
3. Health related QoL: HUI, SF36
Achtergrond van het onderzoek
Does exposure to tinnitus decrease fear and tinnitus-disability, as opposed to masking tinnitus?
Method: In a RCT, 250 tinnitus-patients (including 15% loss to follow-up) recently diagnosed with tinnitus will be randomized (stratified on severity) in a masking or exposure condition, with tinnitus-disability and severity as independents and tinnitus-related fear, threat-appraisal, avoidance/safety behaviour, and psychoacoustic measures [41] as dependent variables, at baseline, pre-/post-treatment, and follow-up at 3 and 6 months after intervention. Tinnitus-related fear-responding and tinnitus-intensity (using self-report diaries) during masking-exposure procedures during 12 weeks (6 weeks masking-exposure procedures; 3 weeks pre-/post-measurements) will be assessed daily.
Exclusion: severe hearing-loss (cut-off point at a pure-tone average of 45dB hearing-level in worst ear). Masking- and exposure-procedures will follow previously developed guidelines [32, 42, 43]. Only masking and exposure elements will be extracted from the formal guidelines for test-purposes
Hypotheses: (a) Tinnitus-fear, threat-appraisal, and tinnitus-related avoidance/safety behaviour decrease in the exposure-condition, not in the masking-condition. (b) Changes in tinnitus-related fear mediate changes in tinnitus-disability.
Doel van het onderzoek
Does exposure-treatment decrease tinnitus-related fear, tinnitus-severity and recovery, when compared to a masking-therapy with use of personalised on-ear masking-devices, or vice versa? Can we identify different sub-groups of patients who benefit more from one approach over the other?
Onderzoeksopzet
1. baseline,
2. pretreatment
3. post treatment
4. 6 months (after baseline)
5. 9 months (after baseline)
Onderzoeksproduct en/of interventie
CBT for tinnitus
Masking-therapy for tinnitus
Publiek
Rilana Cima
Maastricht 6200 MD
The Netherlands
0031 433881460
r.cima@maastrichtuniversity.nl
Wetenschappelijk
Rilana Cima
Maastricht 6200 MD
The Netherlands
0031 433881460
r.cima@maastrichtuniversity.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Score on Tinnitus questionnaire of TQ>30
- No previous masking or exposure therapy of minimally 5 years before inclusion
- Aged 18 plus
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Hearing loss of more than 40 dB in either/both ears
- Limited knowledge: reading and writing skills in Dutch language
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6235 |
| NTR-old | NTR6415 |
| CCMO | NL61673.015.17 |
| OMON | NL-OMON44287 |
Samenvatting resultaten
2. Fuller, T. E., Haider, H. F., Kikidis, D., Lapira, A., Mazurek, B., Norena, A., . . . Cima, R. F. F.(2017). Different Teams, Same Conclusions? A Systematic Review of Existing Clinical Guidelines for the Assessment and Treatment of Tinnitus in Adults. Front Psychol, 8, 206. doi: 10.3389/fpsyg.2017.00206<br>
3. Hall, D. A. Haider, H. Szczepek, A. J.Lau, P.Rabau, S.Jones-Diette, J.Londero, A.Edvall, N. K.Cederroth, C. R.Mielczarek, M.Fuller, T.Batuecas-Caletrio, A.Brueggemen, P.Thompson, D. M.Norena, A. Cima, R. F. F..Mehta, R. L.Mazurek, B.. (2016). Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults. Trials, 17(1), 270. doi: 10.1186/s13063-016-1399-9<br>
4. Lopez-Escamez, J. A., Bibas, T., Cima, R. F.F. Van de Heyning, P., Knipper, M., Mazurek, B., . . . Cederroth, C. R. (2016). Genetics of Tinnitus: An Emerging Area for Molecular Diagnosis and Drug Development. Front Neurosci, 10, 377. doi: 10.3389/fnins.2016.00377<br>
5. Muller, K., Edvall, N. K., Idrizbegovic, E., Huhn, R., Cima, R. F.F.., Persson, V., . . . Cederroth, C. R. (2016). Validation of Online Versions of Tinnitus Questionnaires Translated into Swedish. Front Aging Neurosci, 8, 272. doi: 10.3389/fnagi.2016.00272<br>
6. Cima, R. F. F., Andersson, G. J., Schmidt, C. J., & Henry, J. (2014). Cognitive-behavioral therapy for Tinnitus: A review of literature. Journal of the American Academy of Audiology. 25(1): 29-61. Impact Factor: 1.63<br>
7. Maes, I.H., Cima, R. F. F., Vlaeyen, J. W. S., Anteunis, L., Baguley, D., El Refaie, A., & Joore, M.A. (2014). Cost-effectiveness of multidisciplinary management of Tinnitus at a specialized Tinnitus centre. Otology & Neurotology 35(5): 787-795. Impact Factor: 1.44 <br>
8. Maes, I. H., Cima, R. F. F., Vlaeyen, J. W., Anteunis, L. J., & Joore, M. A. (2013). Tinnitus: a cost study. Ear and Hearing, 34(4), 508-514. Impact Factor: 2.06<br>
9. Andersson, G., Hesser, H., Cima, R. F. F., & Weise, C. (2013). Autobiographical memory specificity in patients with tinnitus versus patients with depression and normal controls. Cognitive behaviour therapy, 42(2), 116-126. Impact Factor: 0.86<br>
10. Cima, R. F. F., Maes, I. H., Joore, M. A., Scheyen, D. J. W. M., El Refaie, A., Baguley, D. M., Anteunis, L. J.C., van Breukelen, G. J. P., & Vlaeyen, J.W.S. (2012). Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. The Lancet, 379(9830), 1951-1959. Impact Factor: 39.06<br>
11. Maes, I. H., Joore, M. A., Cima, R. F. F., Vlaeyen, J. W. S., & Anteunis, L. J. (2011). Assessment of health state in patients with tinnitus: a comparison of the EQ-5D and HUI mark III. Ear and Hearing, 32(4), 428-435. Impact Factor: 2.06<br>
12. Cima, R. F. F., Vlaeyen, J. W. S., Maes, I. H. L., Joore, M. A., & Anteunis, L. J. C. (2011). Tinnitus Interferes With Daily Life Activities: A Psychometric Examination of the Tinnitus Disability Index. Ear and Hearing, 32(5), 623-633. Impact Factor: 2.06<br>
13. Cima, R. F. F., Crombez, G., & Vlaeyen, J. W. S. (2011). Catastrophizing and Fear of Tinnitus Predict Quality of Life in Patients With Chronic Tinnitus. Ear and Hearing, 32(5), 634-641. Impact Factor: 2.06<br>
14. Cima, R. F. F., Joore, M.A., Maes, I.H., Scheyen, D.J.W.S., Refaie, A. E., Baguley, D. M., Vlaeyen, J. W. S., Anteunis, L.J.C. (2009). Cost-effectiveness of multidisciplinary management of Tinnitus at a specialized Tinnitus centre. BMC Health Services Research, 9, 29. Impact Factor: 1.77<br>
15. Maes, I. H., Joore, M. A., Cima, R. F. F., Vlaeyen, J. W. S., & Anteunis, L. J. (2008). QL5 comparison of EQ-5D and HUI3 in patients with tinnitus. Value in Health 01/2008; 11(6). Impact Factor: 2.19