Rilana F F Cima1, Gerard van Breukelen2, Johan W S Vlaeyen3. 1. Department of Clinical Psychological Science, Maastricht University, P.O.Box 616, 6200 MD, Maastricht, The Netherlands; Adelante, Centre of Research and Expertise in Rehabilitation & Audiology, Zandbergsweg 111, 6432 CC, Hoensbroek, The Netherlands. Electronic address: r.cima@maastrichtuniversity.nl. 2. Department of Methodology and Statistics, Maastricht University, P.O.Box 616, 6200 MD, Maastricht, The Netherlands. Electronic address: Gerard.vbreukelen@maastrichtuniversity.nl. 3. Department of Clinical Psychological Science, Maastricht University, P.O.Box 616, 6200 MD, Maastricht, The Netherlands; Research Group Health Psychology, University of Leuven, Tiensestraat 102, 3000, Leuven, Belgium. Electronic address: johannes.vlaeyen@kuleuven.be.
Abstract
OBJECTIVE:Cognitive behavioural treatments (CBT) for the reduction of tinnitus complaints have been shown to be effective; however the specific mechanisms of change are yet to be unveiled. Reductions in tinnitus-related fear have been indicated to be an important factor in alleviating tinnitus suffering. The role of tinnitus-related fear has been proposed as a mediator explaining the cognitive behavioural treatment effects on tinnitus severity, tinnitus-related impairment and general quality of life of tinnitus patients. METHODS: A two-group, single-centre RCT was carried out with adult tinnitus patients (n = 492), with 3 follow-up assessments up to 12 months after randomization. Patients were randomly assigned to Usual Care (UC) or Specialised cognitive behavioral stepped Care (SC). A repeated-measures design, with group as a between subjects factor, and time as the within-subject factor, was used in an intention-to-treat analysis. Mixed regressions for assessing mediation effects were performed with general health, tinnitus distress, tinnitus related impairment as the dependent variables and tinnitus related fear as the mediator variable. RESULTS: Tinnitus-related fear appears to mediate part of the treatment benefits of specialized CBT for Tinnitus, as compared to usual care, with respect to increased quality of life ratings, and decreased tinnitus severity and tinnitus related impairments. CONCLUSIONS: The effectiveness of specialized cognitive behavioural treatment approaches for tinnitus might be partly explained by significant reductions in tinnitus-related fear. These results are relevant in that currently, though CBT approaches in tinnitus management have been proven to lead to decreased suffering of tinnitus patients, the psychological mechanisms causing these benefits are still to be discovered.
RCT Entities:
OBJECTIVE: Cognitive behavioural treatments (CBT) for the reduction of tinnitus complaints have been shown to be effective; however the specific mechanisms of change are yet to be unveiled. Reductions in tinnitus-related fear have been indicated to be an important factor in alleviating tinnitus suffering. The role of tinnitus-related fear has been proposed as a mediator explaining the cognitive behavioural treatment effects on tinnitus severity, tinnitus-related impairment and general quality of life of tinnituspatients. METHODS: A two-group, single-centre RCT was carried out with adult tinnituspatients (n = 492), with 3 follow-up assessments up to 12 months after randomization. Patients were randomly assigned to Usual Care (UC) or Specialised cognitive behavioral stepped Care (SC). A repeated-measures design, with group as a between subjects factor, and time as the within-subject factor, was used in an intention-to-treat analysis. Mixed regressions for assessing mediation effects were performed with general health, tinnitus distress, tinnitus related impairment as the dependent variables and tinnitus related fear as the mediator variable. RESULTS:Tinnitus-related fear appears to mediate part of the treatment benefits of specialized CBT for Tinnitus, as compared to usual care, with respect to increased quality of life ratings, and decreased tinnitus severity and tinnitus related impairments. CONCLUSIONS: The effectiveness of specialized cognitive behavioural treatment approaches for tinnitus might be partly explained by significant reductions in tinnitus-related fear. These results are relevant in that currently, though CBT approaches in tinnitus management have been proven to lead to decreased suffering of tinnituspatients, the psychological mechanisms causing these benefits are still to be discovered.
Authors: Stefan Schoisswohl; Berthold Langguth; Martin Schecklmann; Alberto Bernal-Robledano; Benjamin Boecking; Christopher R Cederroth; Dimitra Chalanouli; Rilana Cima; Sam Denys; Juliane Dettling-Papargyris; Alba Escalera-Balsera; Juan Manuel Espinosa-Sanchez; Alvaro Gallego-Martinez; Efi Giannopoulou; Leyre Hidalgo-Lopez; Michael Hummel; Dimitris Kikidis; Michael Koller; Jose A Lopez-Escamez; Steven C Marcrum; Nikolaos Markatos; Juan Martin-Lagos; Maria Martinez-Martinez; Marta Martinez-Martinez; Maria Mata Ferron; Birgit Mazurek; Nicolas Mueller-Locatelli; Patrick Neff; Kevin Oppel; Patricia Perez-Carpena; Paula Robles-Bolivar; Matthias Rose; Tabea Schiele; Axel Schiller; Jorge Simoes; Sabine Stark; Susanne Staudinger; Alexandra Stege; Nicolas Verhaert; Winfried Schlee Journal: Trials Date: 2021-12-04 Impact factor: 2.279