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 J Stokroos, Adriana L Smit
BMJ Open February 25, 2020 DOI: 10.1136/bmjopen-2019-033210 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled non-inferiority trial (protocol) Peer reviewed |
|---|---|
| Sample size | 54 |
| Population | Adults with chronic subjective tinnitus for at least 6 months and a Tinnitus Functional Index score of 32 or higher |
| Interventions | Mindfulness-based cognitive therapy (MBCT) Cognitive behavioural therapy (CBT) |
| Duration | 12-month follow-up after end of therapy |
| Measures | Tinnitus Functional Index (TFI) |
| Topics | Meditation |
| Keywords | Humans Tinnitus Auditory perception Psychotherapy, group Research design Quality of life Adult Middle aged Female Cognitive behavioral therapy |
| Key findings | Proposes that MBCT will be non-inferior to CBT for reducing tinnitus distress at 12 months after treatment, defined as a mean TFI decrease no worse than CBT's within a 13-point margin. Also expects MBCT to be non-inferior on most secondary outcomes and to show a significant difference favouring MBCT for mindfulness awareness. |
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.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 13
- Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders American Journal of Psychiatry July 1, 1992
- Mindfulness Interventions Annual Review of Psychology September 30, 2016
- Mindfulness meditation for the treatment of chronic low back pain in older adults: A randomized controlled pilot study ☆ Pain June 4, 2007
- The Effect of Mindfulness-Based Interventions on Tinnitus Distress. A Systematic Review. Frontiers in Neurology 2019
- A randomised controlled study of mindfulness meditation versus relaxation therapy in the management of tinnitus. The Journal of Laryngology and Otology June 2017
and 8 more in the library