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      MinT-trial: Mindfulness versus cognitive behavioural therapy in Tinnitus patients: protocol for a randomised controlled, non-inferiority trial

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          Abstract

          Introduction

          Chronic subjective tinnitus is a condition that affects 5.1% to 42.7% of the population, depending on the definition and studied population. Evidence-based treatment options are limited. Cognitive Behavioural Therapy (CBT) has been proven effective to improve quality of life and to diminish tinnitus distress. Positive short-term effects of mindfulness-based interventions on tinnitus distress have been reported; however, the longer term effects remain to be studied.

          Methods and analysis

          We designed a monocentre randomised controlled, non-inferiority trial to compare the effectiveness of mindfulness-based cognitive therapy (MBCT) and CBT in chronic tinnitus patients. Fifty-four patients (≥32 on the Tinnitus Functional Index (TFI), suffering from tinnitus for at least 6 months) will be included in the trial and randomised into one of two intervention groups. One group will receive MBCT, the other group will receive CBT. Our primary objective is to determine whether MBCT is non-inferior to (as good as) CBT on tinnitus distress (TFI) in chronic tinnitus patients at 12 months follow-up after end of therapy. Non-inferiority will be declared if the mean decrease in TFI score for MBCT is no worse than the mean decrease in TFI score in CBT, with statistical variability, with a margin of 13 points. Most secondary objectives (tinnitus severity of problem, tinnitus intrusiveness, quality of life, anxiety, depression, symptoms of psychopathology, perceived tinnitus complaints, coping style (mostly validated questionnaires)) are expected to show non-inferiority to MBCT compared with CBT. We expect a significant difference between MBCT and CBT for mindfulness awareness.

          Ethics and dissemination

          This research protocol was approved by the Institutional Review Board of the UMC Utrecht (NL67838.041.18, V.4, April 2019). The trial results will be made accessible to the public in a peer-review journal.

          Trial registration number

          NL7745.

          Related collections

          Most cited references 28

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          Phantom auditory perception (tinnitus): mechanisms of generation and perception.

          Phantom auditory perception--tinnitus--is a symptom of many pathologies. Although there are a number of theories postulating certain mechanisms of its generation, none have been proven yet. This paper analyses the phenomenon of tinnitus from the point of view of general neurophysiology. Existing theories and their extrapolation are presented, together with some new potential mechanisms of tinnitus generation, encompassing the involvement of calcium and calcium channels in cochlear function, with implications for malfunction and aging of the auditory and vestibular systems. It is hypothesized that most tinnitus results from the perception of abnormal activity, defined as activity which cannot be induced by any combination of external sounds. Moreover, it is hypothesized that signal recognition and classification circuits, working on holographic or neuronal network-like representation, are involved in the perception of tinnitus and are subject to plastic modification. Furthermore, it is proposed that all levels of the nervous system, to varying degrees, are involved in tinnitus manifestation. These concepts are used to unravel the inexplicable, unique features of tinnitus and its masking. Some clinical implications of these theories are suggested.
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            Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders.

            This study was designed to determine the effectiveness of a group stress reduction program based on mindfulness meditation for patients with anxiety disorders. The 22 study participants were screened with a structured clinical interview and found to meet the DSM-III-R criteria for generalized anxiety disorder or panic disorder with or without agoraphobia. Assessments, including self-ratings and therapists' ratings, were obtained weekly before and during the meditation-based stress reduction and relaxation program and monthly during the 3-month follow-up period. Repeated measures analyses of variance documented significant reductions in anxiety and depression scores after treatment for 20 of the subjects--changes that were maintained at follow-up. The number of subjects experiencing panic symptoms was also substantially reduced. A comparison of the study subjects with a group of nonstudy participants in the program who met the initial screening criteria for entry into the study showed that both groups achieved similar reductions in anxiety scores on the SCL-90-R and on the Medical Symptom Checklist, suggesting generalizability of the study findings. A group mindfulness meditation training program can effectively reduce symptoms of anxiety and panic and can help maintain these reductions in patients with generalized anxiety disorder, panic disorder, or panic disorder with agoraphobia.
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              The effects of mindfulness-based stress reduction therapy on mental health of adults with a chronic medical disease: a meta-analysis.

              The objective of this study was to examine the effectiveness of mindfulness-based stress reduction (MBSR) on depression, anxiety and psychological distress across populations with different chronic somatic diseases. A systematic review and meta-analysis were performed to examine the effects of MBSR on depression, anxiety, and psychological distress. The influence of quality of studies on the effects of MBSR was analyzed. Eight published, randomized controlled outcome studies were included. An overall effect size on depression of 0.26 was found, indicating a small effect of MBSR on depression. The effect size for anxiety was 0.47. However, quality of the studies was found to moderate this effect size. When the studies of lower quality were excluded, an effect size of 0.24 on anxiety was found. A small effect size (0.32) was also found for psychological distress. It can be concluded that MBSR has small effects on depression, anxiety and psychological distress in people with chronic somatic diseases. Integrating MBSR in behavioral therapy may enhance the efficacy of mindfulness based interventions. Copyright 2010 Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2020
                25 February 2020
                : 10
                : 2
                Affiliations
                [1 ] departmentDepartment of Otorhinolaryngology, Head and Neck Surgery , University Medical Center Utrecht , Utrecht, The Netherlands
                [2 ] departmentDepartment of Otorhinolaryngology , University Medical Center Utrecht Brain Center, Utrecht University , Utrecht, The Netherlands
                [3 ] departmentDepartment of Psychiatry , University Medical Center Utrecht , Utrecht, The Netherlands
                Author notes
                [Correspondence to ] Maaike Maartje Rademaker; m.m.rademaker-3@ 123456umcutrecht.nl
                Article
                bmjopen-2019-033210
                10.1136/bmjopen-2019-033210
                7045014
                32102813
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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                Ear, Nose and Throat/Otolaryngology
                1506
                1690
                Protocol
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