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

BMJ open
January 1, 1970
Maaike Maartje Rademaker et al. (6 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether mindfulness-based cognitive therapy (MBCT) is non-inferior to cognitive behavioral therapy (CBT) in reducing tinnitus distress in chronic tinnitus patients at 12 months follow-up.

Results Summary

The study expects MBCT to be non-inferior to CBT for tinnitus distress and most secondary outcomes, with a significant difference favoring MBCT for mindfulness awareness. Results will be published post-trial.

Population

Chronic tinnitus patients (≥32 on the Tinnitus Functional Index, suffering for at least 6 months).

Effective Dosage

Not specified

Duration

Not specified (follow-up at 12 months post-therapy)

Interactions

None mentioned

Extracted Claims (13)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Cognitive Behavioural Therapy (CBT)
increase
quality of life
-
-
has been proven effective to improve
#1
Cognitive Behavioural Therapy (CBT)
decrease
tinnitus distress
-
-
has been proven effective to diminish
#2
mindfulness-based interventions
decrease
tinnitus distress
-
-
Positive short-term effects
#3
mindfulness-based cognitive therapy (MBCT)
decrease
tinnitus distress (TFI)
chronic tinnitus patients
margin of 13 points
is non-inferior to (as good as)
#4
mindfulness-based cognitive therapy (MBCT)
no change
tinnitus severity of problem
-
-
are expected to show non-inferiority
#5
mindfulness-based cognitive therapy (MBCT)
no change
tinnitus intrusiveness
-
-
are expected to show non-inferiority
#6
mindfulness-based cognitive therapy (MBCT)
no change
quality of life
-
-
are expected to show non-inferiority
#7
mindfulness-based cognitive therapy (MBCT)
no change
anxiety
-
-
are expected to show non-inferiority
#8
mindfulness-based cognitive therapy (MBCT)
no change
depression
-
-
are expected to show non-inferiority
#9
mindfulness-based cognitive therapy (MBCT)
no change
symptoms of psychopathology
-
-
are expected to show non-inferiority
#10
mindfulness-based cognitive therapy (MBCT)
no change
perceived tinnitus complaints
-
-
are expected to show non-inferiority
#11
mindfulness-based cognitive therapy (MBCT)
no change
coping style
-
-
are expected to show non-inferiority
#12
mindfulness-based cognitive therapy (MBCT)
increase
mindfulness awareness
-
-
significant difference
#13
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.

Medical Subject Headings (MeSH)
AdultAuditory PerceptionClinical ProtocolsCognitive Behavioral TherapyFemaleHumansMaleMiddle AgedMindfulnessPsychotherapy, GroupQuality of LifeRandomized Controlled Trials as TopicResearch DesignTinnitus
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations2
Citations/Year0.4
Relative Citation Ratio0.20
NIH Percentile10.1%
Research Impact Scores
APT Score0.25
Weight Score1.54
Normalized Score0.67
Related Supplements
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