EMDR as a Treatment for Tinnitus (EMDR)
Primary Purpose
Tinnitus
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EMDR
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
Inclusion Criteria:
- 1. 'Subjective Idiopathic Tinnitus', specifically 'Chronic Decompensated Tinnitus' with a THI score of 38 to 100.
2. Tinnitus for greater than 6 months duration. 3. Aged over 18 4. Willing to commit to a full course of EMDR therapy
Exclusion Criteria:
-
Sites / Locations
- Norfolk and Norwich University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EMDR group
Arm Description
This is the treatment arm that will receive EMDR therapy
Outcomes
Primary Outcome Measures
Change in tinnitus handicap inventory score
Tinnitus questionnaire
Secondary Outcome Measures
Beck Depression Inventory (T0, T1, T2)
Depression questionnaire
Beck Anxiety Inventory(T0, T1, T2)
Anxiety questionnaire
Posttraumatic Stress Diagnostic Scale (T0, T1, T2)
Post traumatic stress questionnaire
Pure Tone Audiogram (T0).
Hearing test
Psychoacoustic parameters: (T0, T1, T2) a. Intensity - Tinnitus loudness estimate using a VAS b. Loudness Discomfort Level (LDL) at 250-8000Hz
Quasi objective measure of tinnitus
Five factor personality inventory (T0)
Personality questionnaire
Free text evaluation of treatment and trial protocol (T2)
Open appraisal of study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03218046
Brief Title
EMDR as a Treatment for Tinnitus
Acronym
EMDR
Official Title
Eye Movement Desensitisation and Reprocessing (EMDR) as a Treatment for Tinnitus: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
October 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie Dawson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
The role of eye movements in the propagation and maintenance of tinnitus has been well established, although the exact neurophysiological mechanisms of how eye movements integrate within the central auditory areas is not fully understood, however functional imaging has suggested a number of neuroanatomical sites. Cognitive science has provided neural networks that model tinnitus, these neural network models were inspired by theoretical models that described possible neural mechanisms mediating tinnitus. The majority of these models rely on the lateral-inhibition network (LIN) to simulate tinnitus and focus on the role of central auditory processing regions as possible anatomical locations of the physiological abnormalities that cause tinnitus. Recent work has identified a number of regions responsible for the generation and modulation of tinnitus including limbic, somatosensory and motor areas.
There has been some encouraging work described in the German literature regarding the effectiveness of EMDR for the treatment of tinnitus. The application of eye movement therapies to treat patients with tinnitus would seem logical considering the context our current understanding of tinnitus; the next step would be to test this theory in the setting of a formal randomised controlled clinical study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMDR group
Arm Type
Experimental
Arm Description
This is the treatment arm that will receive EMDR therapy
Intervention Type
Behavioral
Intervention Name(s)
EMDR
Intervention Description
Eye Movement Desensitisation and Reprocessing
Primary Outcome Measure Information:
Title
Change in tinnitus handicap inventory score
Description
Tinnitus questionnaire
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (T0, T1, T2)
Description
Depression questionnaire
Time Frame
6 months
Title
Beck Anxiety Inventory(T0, T1, T2)
Description
Anxiety questionnaire
Time Frame
6 months
Title
Posttraumatic Stress Diagnostic Scale (T0, T1, T2)
Description
Post traumatic stress questionnaire
Time Frame
6 months
Title
Pure Tone Audiogram (T0).
Description
Hearing test
Time Frame
6 months
Title
Psychoacoustic parameters: (T0, T1, T2) a. Intensity - Tinnitus loudness estimate using a VAS b. Loudness Discomfort Level (LDL) at 250-8000Hz
Description
Quasi objective measure of tinnitus
Time Frame
6 months
Title
Five factor personality inventory (T0)
Description
Personality questionnaire
Time Frame
6 months
Title
Free text evaluation of treatment and trial protocol (T2)
Description
Open appraisal of study
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 1. 'Subjective Idiopathic Tinnitus', specifically 'Chronic Decompensated Tinnitus' with a THI score of 38 to 100.
2. Tinnitus for greater than 6 months duration. 3. Aged over 18 4. Willing to commit to a full course of EMDR therapy
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Phillips
Organizational Affiliation
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
12. IPD Sharing Statement
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EMDR as a Treatment for Tinnitus
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