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临床试验/NCT07183826
NCT07183826招募中不适用

Internet-Based Mindfulness-Based Cognitive Therapy (iMBCT) for Chronic Tinnitus Patients: a Randomized Controlled Trial Protocol

University of Warsaw1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
78
试验地点
1
主要终点
Anxiety and Depression symptoms

研究概览

简要总结

This study tested a 6-week, internet-based Mindfulness-Based Cognitive Therapy (MBCT) program designed to help people experiencing distress related to chronic tinnitus. Tinnitus is condition that can cause anxiety, depression, and negatively impact the quality of life.

The investigators compare the online MBCT program to a wait-list group. Study aims to measure tinnitus distress, symptoms of anxiety, depression, mindfulness traits, and self-compassion before the program, right after, one month later, and six months later.

详细描述

Tinnitus, the perception of sound without an external source, affects about 10-15% of people worldwide, with 2-3% experiencing severe distress. Large studies estimate that around 14% of adults report tinnitus, and about 2% suffer from a disabling form. In Europe, roughly one in seven adults is affected. Tinnitus often occurs alongside anxiety, depression, insomnia, and reduced quality of life. Even mild tinnitus has been linked to poorer sleep and higher levels of anxiety and depression.

Despite extensive research, there is no universal medical cure for tinnitus. As a result, treatment increasingly focuses on psychological and behavioral methods that aim to reduce distress and promote habituation. Cognitive Behavioral Therapy (CBT) is the current gold standard, reliably easing distress and improving coping, though it is not effective for everyone and access remains limited. This has led to growing interest in mindfulness-based approaches, such as Mindfulness-Based Cognitive Therapy (MBCT), which combine mindfulness practices with cognitive strategies focused on acceptance rather than control of symptoms.

Mindfulness-based treatments target the negative thoughts, catastrophic interpretations, and avoidance behaviors that sustain tinnitus distress. Acceptance of tinnitus has been shown to improve quality of life and reduce depression and distress. By fostering non-judgmental awareness of the present moment, MBCT helps patients shift from struggling against tinnitus toward acceptance.

Clinical research shows that mindfulness approaches can reduce tinnitus severity, psychological distress, and negative thinking. Trials demonstrate that MBCT and Mindfulness-Based Stress Reduction (MBSR) are effective, with some studies finding MBCT more beneficial than relaxation therapies, and benefits lasting for months. Online versions of mindfulness-based tinnitus programs have also proven feasible and helpful, particularly during the COVID-19 pandemic. Ongoing studies directly comparing MBCT with CBT further highlight the expanding role of mindfulness in tinnitus care.

Mindfulness-Based Cognitive Therapy (MBCT) MBCT is an eight-week, group-based psychological program originally developed to prevent relapse in recurrent depression. It combines mindfulness meditation practices with cognitive-behavioral therapy strategies, fostering non-judgmental awareness of present-moment experience, greater cognitive flexibility, and reduced reactivity to negative thoughts and emotions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Willingness and ability to participate in online therapy.
  • •Polish language proficiency.
  • •18 years or older.
  • •Suffering from chronic tinnitus for at least 3 months.
  • •A score of ≥32 on the TFI.

排除标准

  • •1) Mentally incapable patients. 2) Patients who have already completed structured mindfulness training.

研究组 & 干预措施

Waiting List Control

Placebo Comparator

Participants in this arm received no active intervention during the 6-week waitlist period but completed all study assessments on the same schedule as intervention arms. After the waiting period, participants were offered to take part in the online MBCT program.

干预措施: No intervention (Behavioral)

Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)

Experimental

A 6-week (42 days), unguided online adaptation of the Mindfulness-Based Cognitive Therapy (MBCT) program. The intervention consisted of six sequential modules delivered through a secure web platform, including guided mindfulness meditations, body scan, mindful movement, and cognitive-behavioral exercises. Participants received audio recordings, written materials, and reflective tasks, along with automated reminder emails. No therapist guidance was provided.

干预措施: Mindfulness-Based Cognitive Therapy (Internet-delivered) (Behavioral)

结局指标

主要结局

Anxiety and Depression symptoms

时间窗: Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)

Instrument: Hospital Anxiety and Depression Scale (HADS), a 14-item self-report instrument designed to assess symptoms of anxiety and depression, with each item rated on a four-point scale. It consists of two sub-scales: HADS-anxiety and HADS-depression, 7 items each. The two-factor structure has been verified. Each sub-scale yields a score ranging from 0 to 21, with higher values indicating more symptoms.

Change in Tinnitus Distress

时间窗: Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32)

Change in Tinnitus Distress from baseline to post-intervention, and follow-up, measured by TFI is a 25-item instrument designed to assess the impact of tinnitus on various aspects of daily functioning, using 11-point Likert scales. Total scores range from 0 to 100, with a minimum clinically important difference (MCID) of 13 points and higher scores indicating greater distress.

次要结局

  • Self-compassion(Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32))
  • Acceptance of Tinnitus(Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32))
  • cognitive and affective mindfulness(Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32))
  • Emotion Regulation(Screening, Baseline (Week 0), Post-intervention (Week 6), Follow-ups (Week 10, 32))

研究者

发起方
University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paweł Holas

MD, PhD, associate professor

University of Warsaw

研究点 (1)

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