Evidence map›Paper›PMID 32102813›Full record

ArticleBMJ open2020

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

Maaike Maartje Rademaker, Inge Stegeman, Arno Lieftink, Metten Somers, Robert Stokroos, Adriana L Smit

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Observational
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Maaike Maartje RademakerDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands m.m.rademaker-3@umcutrecht.nl.ORCID 0000-0002-4904-1394
Inge StegemanDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Arno LieftinkDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Metten SomersDepartment of Psychiatry, University Medical Center Utrecht, Utrecht, The Netherlands.
Robert StokroosDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Adriana L SmitDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic 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.

Indexed as

Cognitive Behavioral TherapyMindfulnessTinnitusAdultAuditory PerceptionEquivalence Trials as TopicFemaleHumansMaleMiddle AgedPsychotherapy, GroupQuality of LifeResearch DesignCognitive Behavioural Therapy (CBT)mindfulnessMindfulness Based Cognitive Therapy (MBCT)Mindfulness Based Intervention (MBI)tinnitusTinnitus Functional Index (TFI)

Identifiers

PMID32102813
PMCPMC7045014

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.