MinT-trial：耳鸣患者的正念疗法与认知行为疗法比较：一项随机对照、非劣效性试验的方案。

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

机构信息

Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands

Department of Otorhinolaryngology, University Medical Center Utrecht Brain Center, Utrecht University, Utrecht, The Netherlands.

出版信息

BMJ Open. 2020 Feb 25;10(2):e033210. doi: 10.1136/bmjopen-2019-033210.

DOI:10.1136/bmjopen-2019-033210

PMID:32102813

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7045014/

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.

摘要

简介

慢性主观性耳鸣是一种影响 5.1%至 42.7%人群的疾病，具体取决于定义和研究人群。目前，基于证据的治疗方法有限。认知行为疗法（CBT）已被证明可有效改善生活质量和减轻耳鸣困扰。有研究报道称，基于正念的干预措施对耳鸣困扰有短期积极影响，但长期效果仍有待研究。

方法和分析

我们设计了一项单中心随机对照非劣效性试验，以比较正念认知疗法（MBCT）和 CBT 在慢性耳鸣患者中的疗效。将纳入 54 名（Tinnitus Functional Index（TFI）≥32，耳鸣至少 6 个月）患者，并随机分为两组干预组。一组接受 MBCT，另一组接受 CBT。我们的主要目的是确定在治疗结束后 12 个月的随访中，MBCT 在慢性耳鸣患者的耳鸣困扰（TFI）方面是否不劣于（与 CBT 一样好）。如果 MBCT 的 TFI 评分平均下降不劣于 CBT 的 TFI 评分平均下降，且具有统计学差异，且差值为 13 分，则可宣布非劣效性。大多数次要目标（耳鸣严重程度、耳鸣侵入性、生活质量、焦虑、抑郁、精神病理学症状、感知耳鸣投诉、应对方式（主要是经过验证的问卷））预计与 CBT 相比，MBCT 表现出非劣效性。我们预计 MBCT 与 CBT 相比，正念意识会有显著差异。