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The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Patients suffering from chronic, subjective tinnitus are on a quest to find a cure or any form of alleviation for their persistent complaint. Current recommended therapy forms provide psychotherapeutic interventions that are intended to train the patient how to deal with the tinnitus sound. Pharmaceutical managements are used to reduce secondary effects of the tinnitus sound such as sleep deprivation, emotional and concentration difficulties, but these treatments do not cure the tinnitus. Recent studies have shown that Tinnitus Retraining Therapy (TRT) significantly improves the quality of life for tinnitus patients. Furthermore, several studies have reported that cognitive behavioral therapy (CBT) relieves a substantial amount of distress by changing dysfunctional cognitions. However, when the tinnitus causes great interference with daily functioning, these treatment methods are not always sufficiently effective. Recent insights show that Eye Movement Desensitization Reprocessing (EMDR) is a highly effective therapy for medically unexplained symptoms such as chronic pain and phantom pain. In scientific research, tinnitus is compared to phantom limb pain. Starting from tinnitus as a phantom percept we therefore aim to demonstrate that the operating mechanisms of EMDR may also be an effective treatment method for patients with subjective tinnitus. The aim of this randomized controlled study with blind evaluator is to examine the effect of EMDR compared to CBT in chronic tinnitus patients. To our knowledge, there are no other studies that evaluate both methods simultaneously. METHODS/DESIGN:A total of 166 patients with subjective, chronic, non-pulsatile tinnitus will be randomized in two treatment groups: TRT + CBT versus TRT + EMDR. The experimental group will receive the bimodal therapy TRT/EMDR and the active control group will receive the bimodal therapy TRT/CBT. Evaluations will take place at baseline before therapy, at the end of the treatment and 3?months after therapy. The score on the Tinnitus Functional Index (TFI) will be used as the primary outcome measurement. Secondary outcome measurements are 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). DISCUSSION: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. So far there has been no prospective, randomized controlled, clinical trial with blind evaluator that compares CBT and EMDR as a treatment for tinnitus. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03114878 . April 14, 2017.

SUBMITTER: Luyten T

PROVIDER: S-EPMC6327461 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial.

Luyten Tine T Van de Heyning Paul P Jacquemin Laure L Van Looveren Nancy N Declau Frank F Fransen Erik E Gilles Annick A

Trials 20190109 1

<h4>Background</h4>Patients suffering from chronic, subjective tinnitus are on a quest to find a cure or any form of alleviation for their persistent complaint. Current recommended therapy forms provide psychotherapeutic interventions that are intended to train the patient how to deal with the tinnitus sound. Pharmaceutical managements are used to reduce secondary effects of the tinnitus sound such as sleep deprivation, emotional and concentration difficulties, but these treatments do not cure t ...[more]

PMID: 30626414

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Project description:BackgroundAdversity and traumatic experiences increase the likelihood of suicidal thoughts and behaviors. Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based, trauma-focused psychotherapy that desensitizes painful memories, so that reminders in the present no longer provoke overwhelming emotional responses. Preliminary evidence suggests that EMDR can be used as an acute intervention in suicidal patients, including those with major depressive disorder. In addition, because of social distancing restrictions during the COVID-19 pandemic, clinicians have been using EMDR on the web and, in the absence of formal evaluations of web-based EMDR, informal reports indicate good results.ObjectiveThe primary aim of this randomized controlled trial is to investigate whether remotely delivered EMDR (targeting experiences associated with suicidal thinking) reduces suicidal thoughts. Secondary aims include examining the impact of remotely delivered EMDR on symptoms of depression, anxiety, posttraumatic stress, emotional dysregulation, and dissociation. We will also report on adverse events in the EMDR group to explore whether targeting suicidal ideation with EMDR is safe. Finally, we will compare dropout rates between the treatment groups.MethodsIn this randomized controlled trial, 80 adults who express suicidal ideation and meet the study criteria will receive either 12 sessions of twice weekly EMDR plus treatment as usual or treatment as usual alone. EMDR sessions will focus on the most distressing and intrusive memories associated with suicidal ideation. Data for primary and secondary objectives will be collected at baseline, 2 months, and 4 months after enrollment. A subsequent longer-term analysis, beyond the scope of this protocol, will examine differences between the groups with respect to the number of posttreatment emergency room visits, hospitalizations, and overall health care use in the year before and after therapy.ResultsThe protocol was approved by the University of Alberta Research Health Ethics Board (protocol ID Pro00090989). Funding for this study was provided by the Mental Health Foundation (grant RES0048906). Recruitment started in May 2021, with a projected completion date of March 2023.ConclusionsThe results of this trial will contribute to knowledge on whether web-based delivery of EMDR is a safe and effective treatment for reducing suicidal ideation and potentially reducing the incidence of suicide attempts in this patient population.Trial registrationClinicalTrials.gov NCT04181047; https://clinicaltrials.gov/ct2/show/NCT04181047.International registered report identifier (irrid)DERR1-10.2196/30711.

Project description:BackgroundUnpleasant experience with the previous menstruation can increase the sensitivity to pain which may lead to moderate to severe pain in patients with dysmenorrhea. Eye movement desensitization and reprocessing (EMDR) is a psychological method to alleviate the distress from unpleasant memories and related events and can be used for other conditions such as anxiety, depression, and chronic pain. This protocol was designed to investigate the effect of EMDR therapy on pain intensity in patients with dysmenorrhea.Methods/designA randomized clinical trial was designed in compliance with the Consolidated Standards of Reporting Trials (CONSORT). Female students who have moderate to severe primary dysmenorrhea (based on a visual analogue scale [VAS] score of at least 4 for two consecutive months) and who live in dormitories at Qazvin University of Medical Sciences in Qazvin, Iran will be invited to participate in the study. The total sample size will be 88 girls, who will be randomly assigned to intervention (N = 44) and control (N = 44) groups. EMDR therapy will be performed for the intervention group, while the control group can use sedative or other pain relife methods as their routin... There will be six treatment sessions, which will be held twice a week. The duration of each session is 30-90 min, according to the convenience of each participant. The data will be collected using the demographic characteristics questionnaire, the VAS, the Subjective Units of Anxiety or Distress Scale (SUD), and the Validity of Cognition Scale (VOC). The data on pain intensity due to primary dysmenorrhea in both groups will be collected at 1 and 2 months before the intervention (to identify eligible participants) and 1 and 2 months after the intervention (follow-ups). Data will be analyzed by using SPSS version 25 software and analysis of variance (ANOVA) with repeated measures with appropriate post hoc tests. A P value of less than 0.05 will be considered significant.DiscussionThe results are expected to provide the information on the efficacy of EMDR therapy to manage moderate to severe pain in patients with primary dysmenorrhea.Ethics and disseminationThe research proposal is approved by the human ethics committee of Qazvin University of Medical Sciences (IR.QUMS.REC.1397.100). The results of this trial will be submitted for publication in a peer-reviewed research journal.Trial registrationIRCT20180823040851N1 . Registered on 6, October 2018.

Project description:BackgroundIrritable bowel syndrome (IBS) is a highly prevalent disorder for which treatment options such as medication, diets, and hypnotherapy either have shown limited effect or relieve symptoms in only a limited subset of patients. Abdominal pain is the key criterion for the diagnosis and is deemed the most distressing IBS symptom, and the most disruptive of everyday life. A growing body of research demonstrates the effect of Eye Movement Desensitization and Reprocessing (EMDR) on chronic pain. EMDR is known as a safe and successful treatment for disorders in which unresolved traumatic memories play a role in the cause or maintenance of symptoms. In IBS, activated memories may increase pain through pain flashbacks and the stress generated by unresolved memories. The aim of this study is to ascertain whether applying EMDR to traumatic memories including pain memories will reduce abdominal pain in IBS patients.MethodsThis study is a randomized controlled trial which will be conducted at a city hospital in the Netherlands. Adult patients with considerable IBS pain (pain intensity at least 60/100 during at least 5/10 days) will be randomly assigned to either EMDR therapy or the wait list. We aim to include 34 participants. The EMDR condition comprises seven sessions, around 90 min in length delivered weekly, the first of which is a case conceptualization session. All participants will be assessed at baseline, post-treatment, and at 3 months follow-up. The primary outcome measure is pain intensity on a Likert scale which is self-reported daily during a 2-week period. Secondary outcomes include similar daily ratings on other IBS symptoms and reported hindrance of valued activities, and also standardized questionnaires on IBS symptoms and Quality of Life. Data will be analyzed by a Linear Mixed Effects Model for repeated measures.DiscussionThe results are expected to gain insight into the effectiveness of EMDR treatment on abdominal pain in IBS. As there are very few effective treatment options for IBS-related abdominal pain, this study could have important implications for clinical practice.Trial registrationHuman ethics committee MEC-U NL71740.100.20. International Clinical Trial Registry Platform: NL8894. Prospectively registered on 28 January 2020.

Project description:BackgroundUp to 60% of patients with bipolar disorder (BD) have a history of traumatic events, which is associated with greater episode severity, higher risk of comorbidity and higher relapse rates. Trauma-focused treatment strategies for BD are thus necessary but studies are currently scarce. The aim of this study is to examine whether Eye Movement Desensitization and Reprocessing (EMDR) therapy focusing on adherence, insight, de-idealisation of manic symptoms, prodromal symptoms and mood stabilization can reduce episode severity and relapse rates and increase cognitive performance and functioning in patients with BD.Methods/designThis is a single-blind, randomized controlled, multicentre trial in which 82 patients with BD and a history of traumatic events will be recruited and randomly allocated to one of two treatment arms: EMDR therapy or supportive therapy. Patients in both groups will receive 20 psychotherapeutic sessions, 60 min each, during 6 months. The primary outcome is a reduction of affective episodes after 12 and 24 months in favour of the EMDR group. As secondary outcome we postulate a greater reduction in affective symptoms in the EMDR group (as measured by the Bipolar Depression Rating Scale, the Young Mania Rating Scale and the Clinical Global Impression Scale modified for BD), and a better performance in cognitive state, social cognition and functioning (as measured by the Screen for Cognitive Impairment in Psychiatry, The Mayer-Salovey-Caruso Emotional Intelligence Test and the Functioning Assessment Short Test, respectively). Traumatic events will be evaluated by The Holmes-Rahe Life Stress Inventory, the Clinician-administered PTSD Scale and the Impact of Event Scale.DiscussionThe results of this study will provide evidence whether a specific EMDR protocol for patients with BD is effective in reducing affective episodes, affective symptoms and functional, cognitive and trauma symptoms.Trial registrationThe trial is registered at ClinicalTrials.gov, identifier: NCT02634372 . Registered on 3 December 2015.

Project description:Non-specific chronic back pain (CBP) is often accompanied by psychological trauma, but treatment for this associated condition is often insufficient.Nevertheless, despite the common co-occurrence of pain and psychological trauma, a specific trauma-focused approach for treating CBP has been neglected to date. Accordingly, eye movement desensitization and reprocessing (EMDR), originally developed as a treatment approach for posttraumatic stress disorders, is a promising approach for treating CBP in patients who have experienced psychological trauma.Thus, the aim of this study is to determine whether a standardized, short-term EMDR intervention added to treatment as usual (TAU) reduces pain intensity in CBP patients with psychological trauma vs. TAU alone.The study will recruit 40 non-specific CBP patients who have experienced psychological trauma. After a baseline assessment, the patients will be randomized to either an intervention group (n?=?20) or a control group (n?=?20). Individuals in the EMDR group will receive ten 90-minute sessions of EMDR fortnightly in addition to TAU. The control group will receive TAU alone. The post-treatment assessments will take place two weeks after the last EMDR session and six months later.The primary outcome will be the change in the intensity of CBP within the last four weeks (numeric rating scale 0-10) from the pre-treatment assessment to the post-treatment assessment two weeks after the completion of treatment.In addition, the patients will undergo a thorough assessment of the change in the experience of pain, disability, trauma-associated distress, mental co-morbidities, resilience, and quality of life to explore distinct treatment effects. To explore the mechanisms of action that are involved, changes in pain perception and pain processing (quantitative sensory testing, conditioned pain modulation) will also be assessed.The statistical analysis of the primary outcome will be performed on an intention-to-treat basis. The secondary outcomes will be analyzed in an explorative, descriptive manner.This study adapts the standard EMDR treatment for traumatized patients to patients with CBP who have experienced psychological trauma. This specific, mechanism-based approach might benefit patients.This trial has been registered with ClinicalTrials.gov (NCT01850875).

Project description:BACKGROUND:Eye movement desensitization and reprocessing (EMDR) is an evidenced-based treatment for posttraumatic stress disorder (PTSD). Forensic mental health services provide assessment and treatment of people with mental illness and a history of criminal offending, or those who are at risk of offending. Forensic mental health services include high, medium, and low-security inpatient settings as well as prison in-reach and community outpatient services. There is a high prevalence of PTSD in forensic settings and posttraumatic experiences can arise in people who violently offend in the context of serious mental illness (SMI). Successful treatment of PTSD may reduce the risk of relapse and improve clinical outcomes for this population. This study aims to assess the efficacy, risk of harm, and acceptability of EMDR within forensic and rehabilitation mental health services, as compared to treatment as usual (routine care). METHODS:This is a single-blind, randomized controlled trial comparing EMDR therapy to the waiting list (routine care). Adult forensic mental health service users (n?=?46) with SMI and meeting the criteria for PTSD will be included in the study. Participants will be randomized after baseline assessment to either treatment as usual plus waiting list for EMDR or to treatment as usual plus EMDR. The EMDR condition comprises nine sessions, around 60?min in length delivered weekly, the first of which is a case conceptualization session. The primary outcomes are clinician and participant-rated symptoms of PTSD, and adverse events. Secondary outcomes include psychotic symptoms, social functioning, level of disability, self-esteem, depressive symptoms, post-trauma cognitions, and broad domains of complex posttraumatic difficulties. A trained assessor blinded to the treatment condition will assess outcomes at baseline, 10?weeks, and 6?months. Additionally, grounded theory qualitative methods will be used to explore participant experience of EMDR for a subset of participants. DISCUSSION:This study will contribute to the currently limited evidence base for EMDR for PTSD in forensic settings. It is the first randomized clinical trial to assess the efficacy, risk of harm, and acceptability of EMDR for PTSD in people with SMI in either forensic, mental health inpatient, or custodial settings. TRIAL REGISTRATION:Australia and New Zealand Clinical Trials Network, ACTRN12618000683235. Registered prospectively on 24 April 2018.

Dataset Information

The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial.

Publications

The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial.

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