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EMDR as a Treatment for Tinnitus (EMDR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218046
Recruitment Status : Completed
First Posted : July 14, 2017
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Tinnitus Behavioral: EMDR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eye Movement Desensitisation and Reprocessing (EMDR) as a Treatment for Tinnitus: A Feasibility Study
Actual Study Start Date : July 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : October 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: EMDR group
This is the treatment arm that will receive EMDR therapy
Behavioral: EMDR
Eye Movement Desensitisation and Reprocessing




Primary Outcome Measures :
  1. Change in tinnitus handicap inventory score [ Time Frame: 6 months ]
    Tinnitus questionnaire


Secondary Outcome Measures :
  1. Beck Depression Inventory (T0, T1, T2) [ Time Frame: 6 months ]
    Depression questionnaire

  2. Beck Anxiety Inventory(T0, T1, T2) [ Time Frame: 6 months ]
    Anxiety questionnaire

  3. Posttraumatic Stress Diagnostic Scale (T0, T1, T2) [ Time Frame: 6 months ]
    Post traumatic stress questionnaire

  4. Pure Tone Audiogram (T0). [ Time Frame: 6 months ]
    Hearing test

  5. Psychoacoustic parameters: (T0, T1, T2) a. Intensity - Tinnitus loudness estimate using a VAS b. Loudness Discomfort Level (LDL) at 250-8000Hz [ Time Frame: 6 months ]
    Quasi objective measure of tinnitus

  6. Five factor personality inventory (T0) [ Time Frame: 6 months ]
    Personality questionnaire

  7. Free text evaluation of treatment and trial protocol (T2) [ Time Frame: 6 months ]
    Open appraisal of study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218046


Locations
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United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Sponsors and Collaborators
Julie Dawson
Investigators
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Principal Investigator: John Phillips Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Publications:
Davis A, El Rafaie A. Epidemiology of tinnitus. In: Tyler RS, (ed). Tinnitus Handbook. San Diego: Singular, 2000; 1-23.
Oren, E. and R. Solomon (2012).
Shapiro F. Efficacy of the eye movement desensitization procedure in the treatment of traumatic memories. J Trauma Stress. 1989;2(2):199-223.
Shapiro F. Eye Movement Desensitization and Reprocessing (EMDR): Basic Principles, Protocols, and Procedures, 2nd Edition. 2001. The Guilford Press.
Kuiken D, Bears M, Miall D, Smith L. Eye Movement Desensitisation Reprocessing Facilitates Attentional Orienting. Imagination, Cognition and Personality. 2002;21:3-20.
National Institute for Clinical Excellence (2005). Post traumatic stress disorder (PTSD): The management of adults and children in primary and secondary care. London: NICE Guidelines. . http://www.oqp.med.va.gov/cpg/PTSD/PTSD_cpg/frameset.htm
van Rood, Y. R. and C. de Roos (2009).

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Responsible Party: Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03218046    
Other Study ID Numbers: 174629
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases