A systematic review and meta-analysis of randomized controlled trials of cognitive–behavioral therapy for tinnitus distress
Research Highlights
► Fifteen randomized, controlled trials of CBT for tinnitus distress were synthesized. ► Cognitive behavior therapy was more effective than controls at post-treatment. ► Effects were maintained at follow-up and were robust. ► Effects were unrelated to the characteristics of the studies. ► Few large-scale, well-controlled trials were identified.
Introduction
Tinnitus is a prevalent chronic health condition defined as a phantom auditory perception of sounds in the ear and/or head in the absence of an external stimulus (Andersson, Baguley, McKenna & McFerran, 2005). These auditory sensations are often described as whistling, hissing or buzzing sounds. It is well-established that a substantial proportion of individuals with the condition report significant distress as a consequence of their tinnitus (Tyler & Baker, 1983). Behavioral and cognitive treatment methods have been developed and adapted to alter the psychological processes that are thought to maintain or contribute to tinnitus distress (Andersson, 2002). The aim of the present study was to examine whether cognitive behavior therapy (CBT) reduces distress associated with tinnitus. We reviewed randomized, controlled trials that assessed the efficacy of CBT for tinnitus-related distress compared with passive (i.e., waiting-list) or active control conditions (i.e., placebo, other treatment) in adults, and quantified the overall effect of CBT using meta-analytic procedures.
Auditory disorders are one of the most prevalent of chronic health conditions. Epidemiological studies indicate that the prevalence of tinnitus for adults falls in the range of 10%–15% (Axelsson and Ringdahl, 1989, Davis and El Refaie, 2000). For approximately 3–5% of general adult population tinnitus is perceived as extremely bothersome, affecting sleep and mood to such an extent that it is difficult to carry out everyday activities (Davis & El Refaie, 2000). The most pronounced effects of tinnitus include problems with concentration, emotions, sleep and hearing (Henry et al., 2005, Tyler and Baker, 1983). Although the overall economical impact of tinnitus remains unknown, untreated severe tinnitus is likely to be associated with substantial economical costs for society (Henry et al., 2005).
Tinnitus is often regarded as a chronic condition which is difficult to treat (Dobie, 1999). Several treatment protocols have been proposed for the management of tinnitus, including sounds masking, hearing aids, pharmacological regimes, counseling, and acupuncture, among others (Henry et al., 2005, Noble, 2008). Despite significant advances within the field, treatments evaluated up to now have failed to produce a cure for the disorder (Andersson, Baguley, et al., 2005). Furthermore, most treatments have limited success in treating disability and distress associated with tinnitus (Dobie, 1999).
Cognitive Behavior Therapy (CBT) is one of the most researched treatments in published outcome studies (Andersson, 2002, Noble, 2008). CBT for tinnitus includes, for example, psycho-education about tinnitus, applied relaxation, positive imagery, cognitive restructuring of negative beliefs about tinnitus, exposure to the sounds, behavioral activation, and mindfulness/attention exercises. The use of CBT techniques to influence the experience of tinnitus emerged in peer-reviewed journals in the mid 80s (e.g., ⁎Lindberg et al., 1989, ⁎Scott et al., 1985). Since then several clinical trials have been published, and a handful of reviews have evaluated the overall efficacy of CBT for tinnitus (Andersson and Lyttkens, 1999, Andersson et al., 1995, Martinez Devesa et al., 2007). These reviews all provide initial empirical evidence that support the efficacy of CBT for tinnitus distress. Only one review, however, restricted inclusion of efficacy studies to randomized controlled trials (Martinez Devesa, et al., 2007). Unfortunately, this Cochrane review was limited to a small number of included studies (N = 6) comprising only 285 participants in total. In fact, the positive effect of CBT for tinnitus has not gone uncontested (McFerran & Baguley, 2009). Consequently, there is still a need to address the question whether CBT is effective in the treatment of annoyance caused by tinnitus. Furthermore, the primary outcome measure selected for the Cochrane review was tinnitus loudness (Martinez Devesa, et al., 2007), which has been found to have little, if any correlation with tinnitus impact (Tyler & Stouffer, 1989). For the current review tinnitus distress was chosen as the primary outcome and mood as a secondary outcome.
The present meta-analysis includes the following improvements as compared to previous reviews in the field. First, it provides a more comprehensive quantified summary of controlled trials. A number of randomized controlled trials have been conducted since that last review was published. Second, analyses were conducted to examine whether characteristics of studies were related to the effects of CBT. No study to date has examined possible moderators of effect sizes in CBT for tinnitus. Third, the methodological quality of the studies was assessed since it can affect the estimation of treatment outcome and subsequently distort the overall treatment effect (Wykes, Steel, Everitt & Tarrier, 2008). To our knowledge no previous study has quantified the methodological quality of CBT studies for tinnitus to examine if there is an association between methodological rigor and the effects of CBT. Fourth, data collected at follow-up in the RCTs were examined and quantified in the present meta-analysis. Little is currently known about whether CBT for tinnitus is effective in the long term. Finally, analyses were conducted to examine the robustness of the findings by examining common bias and artifacts in meta-analysis (Staines & Cleland, 2007).
Section snippets
Search strategies and study selection
Fig. 1 displays a flow chart of the process of selecting studies. Eligible studies were identified through several search strategies. An extensive literature search of abstracts in PsychINFO, PubMed, and the Cochrane Library was conducted (from the 1st available year to September 2009). Abstracts were identified by combining terms indicative of cognitive behavior therapy (Behavior therapy, Cognitive therapy, and Cognitive Behavioral Therapy), randomized controlled trials (Trial, Randomized, and
Study characteristics of included studies
A total of 1091 participants with tinnitus were included in the 15 studies that were selected. Characteristics of each study are provided in Table 1. Studies were conducted in Germany (n = 7), Sweden (n = 7), and Australia (n = 1). We included three unpublished studies. Five studies included more than one control comparison. Control groups used in the studies included waiting-list (n = 14), tinnitus education/information (n = 3), sound therapy/training (n = 2), and yoga/relaxation training (n = 2). Eight
Discussion
To our knowledge this is the largest review of randomized controlled trials of CBT for tinnitus including 9 more trials and 806 more participants than the comprehensive systematic review conducted (Martinez Devesa et al., 2007). The present meta-analysis is probably the first review to consider trial methodological variability and potential moderators in the calculations of benefit of CBT for tinnitus. Moreover, data from follow-up assessments were included to evaluate and quantify the overall
Acknowledgements
We wish to thank all the authors in participating studies. We also wish to thank Robert Johansson for assistance in the preparation of the manuscript. All authors have carried out trials on CBT for tinnitus.
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References marked with an asterisk indicate studies included in the meta-analysis.