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临床试验/NCT03218046
NCT03218046已完成不适用

Eye Movement Desensitisation and Reprocessing (EMDR) as a Treatment for Tinnitus: A Feasibility Study

Julie Dawson2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Julie Dawson
入组人数
23
试验地点
2
主要终点
Change in tinnitus handicap inventory score

研究概览

简要总结

Tinnitus may be considered as a form of phantom auditory sensation and as such parallels may be drawn with other forms of phantom sensation, such as the sensation of pain in an amputated limb (phantom limb pain). There has been recent interest in the use of eye movement therapies to treat patients with phantom sensations such as these. The role of eye movements in the propagation and maintenance of tinnitus has also been well established. The main aim of this study is to evaluate the effectiveness of an established form of eye movement therapy called Eye Movement Desensitisation and Reprocessing (EMDR). This research is important as EMDR has produced encouraging results for other forms of phantom sensation and current models of tinnitus fit well with the proposed mode of action of EMDR. Tinnitus is very prevalent in our population and is often associated with significant discomfort; however, there is a severe lack of effective treatments based on well designed clinical trials. The investigator wishes to assess the usefulness of EMDR against the current treatment that is available in many institutions including the Investigator's own. The Investigator intends to recruit 15-30 patients initially to run a pilot study, before embarking on a larger scale study. The Investigator hopes that this pilot study will run over the course of a year. If this study demonstrates a significant improvement in tinnitus in patient undergoing EMDR, this will be an important step forward not only for treating patients with this disorder, but also for understanding the pathways that initiate, propagate and maintain tinnitus perception.

详细描述

Tinnitus is a common, yet poorly understood condition. In the UK, a large study using data from more than 500,000 people has found a prevalence of tinnitus of 16.2% (defined as any noise in the ear/s lasting longer than five minutes) and a prevalence of bothersome tinnitus as 3.8% (those who were moderately or severely bothered by their tinnitus on a four point Likert scale). Other international studies have also found a high prevalence of 30% with a total of 6% of the study population reporting incapacitating symptoms from tinnitus. Despite the high worldwide prevalence of tinnitus and the large number of proposed therapies available, there is a distinct paucity of well controlled trials in the literature to support an effective treatment.

Tinnitus may be considered as a form of phantom auditory perception and as such parallels may be drawn with other forms of phantom sensation, there has been recent interest in the use of eye movement therapies to treat patients with phantom sensations such as phantom limb pain. Both studies of those with tinnitus and phantom limb pain have suggested a psychological component such as certain premorbid personality traits may also contribute or predispose to these conditions and consequently be helped by psychological therapies.

Eye Movement Desensitisation and Reprocessing (EMDR) was first described by Shapiro in 1989 and requires the subject to perform relatively rapid movements of the eyes. Its application has been particularly documented in the context of post-traumatic stress disorder (PTSD). EMDR has been described as an integrative psychotherapy, due to its assimilation of various elements from diverse psychotherapies. A number of models have been proposed to account for the role of eye movements in EMDR, these include Shapiro's Adaptive Information Processing Model, Dyck's conditioning model, attentional processing accounts and theories of reverse learning . A recurrent mechanism in a number of these accounts is that of the orientating reflex. MacCollock and Feldman argue that lateral eye-movements trigger an investigatory component of this reflex to assess safety with regard to potential external threats . Where threats are positively identified, a flight or flight response is initiated; in situations where no danger is identified a functional reduction in arousal takes place. Support for this reassurance response in non-clinical patients has been demonstrated using auditory stimuli. Overlap between these concepts and theories related to the perception of tinnitus bode well, especially when one considers the neurophysiological model proposed by Jastreboff.

Since its introduction in 1989, numerous controlled studies have been conducted to evaluate EMDR's utility as a treatment for various forms of trauma-related complaints, including PTSD. The positive results have established EMDR as an effective trauma treatment and have prompted numerous professional organisations to recognise its efficacy, beginning with the American Psychological Association's (APA) Division 12 Task Force on Psychological Interventions in 1998. Since then, the NHS the International Society for Traumatic Stress Studies , the Israeli National Council for Mental Health , and the Northern Ireland Department of Health have also supported EMDR. Most recently, the US Departments of Defence and Veterans Affairs stated that EMDR was an effective treatment of trauma, as did the American Psychiatric Association . It has also been found to be helpful in medically unexplained symptoms and somatoform disorders.

Other forms of eye movement therapy have been popularised, such as eye movement integration therapy (EMI) in which eye movements in specific directions provide access strategies to different sensory domains. EMI was originally developed from research in the field of neuro-linguistic programming (NLP) and has also been widely used in the treatment of PTSD. EMI uses slower eye movements that are thought to access internal dialogue or emotional and feeling areas of the brain. Initially the concept of specifically accessing domains associated with auditory-based cue was appealing as a therapy for an auditory based pathology, however, despite initial enthusiasm for EMI the specificity of these associations has been disputed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • 'Subjective Idiopathic Tinnitus', specifically 'Chronic Decompensated Tinnitus' with a THI score of 38 to
  • Tinnitus for greater than 6 months duration.
  • Aged over 18
  • Willing to commit to a full course of EMDR therapy

排除标准

  • 未提供

研究组 & 干预措施

EMDR group

Experimental

This is the treatment arm that will receive EMDR therapy

干预措施: EMDR (Behavioral)

结局指标

主要结局

Change in tinnitus handicap inventory score

时间窗: 6 months

Tinnitus questionnaire

次要结局

  • Beck Anxiety Inventory(T0, T1, T2)(6 months)
  • Five factor personality inventory (T0)(6 months)
  • Beck Depression Inventory (T0, T1, T2)(6 months)
  • Posttraumatic Stress Diagnostic Scale (T0, T1, T2)(6 months)
  • Pure Tone Audiogram (T0).(6 months)
  • Psychoacoustic parameters: (T0, T1, T2) a. Intensity - Tinnitus loudness estimate using a VAS b. Loudness Discomfort Level (LDL) at 250-8000Hz(6 months)
  • Free text evaluation of treatment and trial protocol (T2)(6 months)

研究者

发起方
Julie Dawson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Julie Dawson

Research Services Manager

Norfolk and Norwich University Hospitals NHS Foundation Trust

研究点 (2)

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