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Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial.

ABSTRACT: BACKGROUND:The psychological treatment of choice for patients with severe posttraumatic stress disorder (PTSD) is cognitive behavioural exposure therapy or Eye Movement Desensitisation Reprocessing (EMDR). Whilst these are the most effective treatments, approximately 30-45% of the patients show no significant improvements and follow-up data are sparse. Furthermore, a proportion of patients with severe trauma does not benefit or avoid exposure therapy due to the potential to overwhelm them. Therefore, it is necessary to search for effective methods that do not require exposure. Metacognitive therapy (MCT), a recent treatment approach to PTSD that does not require exposure, has potential strong treatment effects but so far a comparison with EMDR has not been made. METHODS/DESIGN:This study is a two-arm, parallel, randomized, superiority trial comparing the effectiveness of MCT with EMDR. One hundred patients with a primary diagnosis of chronic PTSD will be included and will receive 12 sessions of one of the treatments. The primary outcome is severity of PTSD symptoms assessed with the Posttraumatic Diagnostic Scale (PDS) measured post-treatment (3 months). Secondary outcomes include symptom severity (PDS) and measures of anxiety, depression, metacognitive beliefs at 3-month and 12-month follow up. DISCUSSION:This randomized study is the first to compare MCT with EMDR with 12-month follow-up. The study will indicate the comparative effectiveness of MCT against EMDR and the stability of effects when delivered in an outpatient clinical setting. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01955590 . Registered on 24 September 2013.

SUBMITTER: Nordahl HM

PROVIDER: S-EPMC5759867 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial.

Nordahl Hans M HM Halvorsen Joar Øveraas JØ Hjemdal Odin O Ternava Mimoza Rrusta MR Wells Adrian A

Trials 20180108 1

<h4>Background</h4>The psychological treatment of choice for patients with severe posttraumatic stress disorder (PTSD) is cognitive behavioural exposure therapy or Eye Movement Desensitisation Reprocessing (EMDR). Whilst these are the most effective treatments, approximately 30-45% of the patients show no significant improvements and follow-up data are sparse. Furthermore, a proportion of patients with severe trauma does not benefit or avoid exposure therapy due to the potential to overwhelm the ...[more]

PMID: 29310718

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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.

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:Background: In recent years, eye movement desensitization and reprocessing (EMDR) has been applied to different psychiatric conditions beyond post-traumatic stress disorder (PTSD), and an increasing number of studies have evaluated its effect on depression. To date, no quantitative synthesis of the efficacy of EMDR on depression has been conducted. Objective: To meta-analytically review the studies on EMDR for depression as the primary target for treatment. Method: Studies with a controlled design evaluating the effect of EMDR on depression were searched on six electronic databases (PubMed, Embase, CINAHL, PsycINFO, Cochrane database, and Francine Shapiro Library) and then selected by two independent reviewers. A systematic review and meta-analysis was conducted. Results: Eleven studies were included for qualitative synthesis. Nine studies were included in the meta-analysis, involving 373 participants. The overall effect size of EMDR for depressive symptoms is large (n = 9, Hedges' g = - 1.07; 95%CI [-1.66; - 0.48]), with high heterogeneity (I 2 = 84%), and corresponds to a 'number needed to treat' of 1.8. At follow-up (range 3-6 months), the effect remains significant but moderate (n = 3, Hedges' g = - 0.62; 95%CI [-0.97; - 0.28]; I 2 = 0%). The effect of EMDR compared with active controls is also moderate (n = 7, g = - 0.68; 95%CI [-0.92; - 0.43]; I 2 = 0%). No publication bias was found, although the results are limited by the small number and poor methodological quality of the included studies. Conclusions: Review findings suggest that EMDR may be considered an effective treatment for improving symptoms of depression, with effects comparable to other active treatments. However, findings need to be interpreted in light of the limited number of the studies and their quality. Further research is required to understand the longer-term of effects EMDR in treating depression and preventing depression relapse. Protocol registration: PROSPERO (CRD42018090086).

Project description:BackgroundPatients 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/designA 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).DiscussionThe 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 registrationClinicalTrials.gov, ID: NCT03114878 . April 14, 2017.

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Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial.

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Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial.

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