The Value of Eye Movement Desensitization Reprocessing in the Treatment of Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Tinnitus Functional Index (TFI)
研究概览
简要总结
A prospective, randomized, controlled, clinical trial with blind evaluator that uses TRT and EMDR as a treatment for tinnitus.
详细描述
Patients with subjective, chronic, non-pulsatile tinnitus will be randomized in two treatment groups: TRT and CBT versus TRT and EMDR. Evaluations will take place at baseline before therapy starts, at the end of the treatment, after 3 months (10 treatment sessions) and 3 months after therapy ends. The Tinnitus Functional Index (TFI) will be used as the primary outcome measurement. Secondary outcome measurements will be the Visual Analogue Scale of Loudness (VAS), Tinnitus Questionnaire (TQ), Hospital Anxiety and Depression Scale (HADS), Hyperacusis Questionnaire (HQ), psychoacoustic measurements and Event-related potentials (ERP). The objective is to evaluate whether the bimodal therapy TRT and EMDR can provide faster and/or more relief from the annoyance experienced in chronic tinnitus patients' daily lives compared to the bimodal therapy TRT and CBT.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Tinnitus type: chronic, subjective, non - pulsatile tinnitus
- •Duration of tinnitus = more than 3 months
- •Minimum age of the patient is 18 years old - maximum age is 75 years old
- •Tinnitus Functional Index (TFI) score ≥ 25 - < 90
- •Stable use of medication during therapy
排除标准
- •HADS - score: anxiety and depression-subscores > 15
- •HQ - score > 40
- •Objective, pulsatile tinnitus
- •Active middle ear pathology
- •Neurological and psychiatry co-morbidity for which currently psychotherapy is ongoing
- •Psychosis, schizophrenia, epilepsy
- •Pregnancy
结局指标
主要结局
Tinnitus Functional Index (TFI)
时间窗: Change will be assessed at 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2). The change will be assessed at every test moment.
The TFI is a self-reported questionnaire, consisting of 25 questions, which assesses the impact of tinnitus on patients' daily lives. The patient answers each question on a Likert scale ranging from 0 to 10. Questions 1 and 3 are expressed in percentages, and the Likert scale ranges from 0 % to 100 %. The total score is calculated with the mean of all questions. The answers are converted and the total score is expressed as a number between 0 and 100. In addition to the total score, the score of eight subscales can be determined. The subscales are the following: intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties attributed to tinnitus, interference with relaxation, reduced quality of life and emotional distress. A decrease in the score on the TFI in the TRT-CBT-treatment group versus a decrease in the TFI-score in the TRT- EMDR-treatment group is the primary focus of attention in this study.
次要结局
- Tinnitus questionnaire (TQ)(There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).The secondary outcome measurements will be assessed at every test moment.)
- Hospital Anxiety and Depression Scale (HADS)(There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).The secondary outcome measurements will be assessed at every test moment.)
- Hyperacusis Questionnaire (HQ)(There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).The secondary outcome measurements will be assessed at every test moment.)
- Psychoacoustic measurements(There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).These measurements will only be used to evaluate within-patient variability.)
- Big Five Inventory - 2 (BFI)(Timeframe within 12 months)
- Visual Analogue Scale (VAS) of loudness(There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).The secondary outcome measurements will be assessed at every test moment.)
- ERP(There will be 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2).The secondary outcome measurements will be assessed at every test moment.)
研究者
Tine Luyten
Tine Luyten Clinical Psychologist
University Hospital, Antwerp