Mindfulness-based Therapy For the Treatment of Chronic Tinnitus: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9)
研究概览
简要总结
In the present randomized waiting-list-controlled study the investigators examined a specific manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.
详细描述
In the current randomized waiting-list-controlled pilot study, we investigate a new manualized therapeutic approach, which is based on mindfulness- and body-psychotherapy and which has been specifically developed for the treatment of tinnitus patients (Tinnitus Atemtherapie; http://www.maria-holl.de/). Essential components of the treatment program include mindfulness, meditation, selfmassage, and breathing exercises. These components are intended to help patients use their inner resources to accept responsibility for themselves, become more self-sufficient and develop symptom acceptance.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic tinnitus (duration ≥ 6 months)
- •German speaking
- •Subjective tinnitus
排除标准
- •Instable medical conditions
- •Objective tinnitus
研究组 & 干预措施
Mindfulness-based therapy
Treatment was performed as group therapy at two training weekends which were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22).
干预措施: Mindfulness-based therapy (Behavioral)
Treatment after waiting time
Treatment was performed after completion of the active arm.
干预措施: Treatment after waiting time (Behavioral)
结局指标
主要结局
Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9)
时间窗: Baseline to Week 9
次要结局
- Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)(Week 9)
- Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)(Week 7)
- Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)(Week 24)
- Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)(Week 7)
- Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)(Week 9)
- Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)(Week 24)
- Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 7)(Week 7)
- Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 9)(Week 9)
- Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 24)(Week 24)
- Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)(Week 7)
- Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)(Week 24)
- Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)(Week 9)
研究者
Berthold Langguth, MD, Ph.D.
Principal Investigator
University of Regensburg