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A Multicenter Phase II Rater-Blinded Randomized Controlled Trial to Compare the Effectiveness of Eye Movement Desensitization Reprocessing Therapy vs. Treatment as Usual in Patients With Substance Use Disorder and History of Psychological Trauma: A Study Design and Protocol.

ABSTRACT: Background: Psychological trauma has a strong negative impact on the onset, course and prognosis of substance use disorders (SUD). Few trauma-oriented treatment approaches have been trialed, but preliminary evidence exists of the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) therapy in improving clinical symptoms in SUD patients. Objective: To assess if EMDR therapy leads to: (1) reduced substance consumption; (2) an improvement in psychopathological and in trauma-related symptoms; and (3) an improvement in overall functioning. Our hypothesis is that the EMDR group will improve in all variables when compared to the treatment as usual (TAU) group at 6 and 12-months visits. Method: In this multicenter phase II rater-blinded randomized controlled trial, 142 SUD patients with a history of psychological trauma will be randomly assigned to EMDR (n = 71) or to TAU (n = 71). Patients in the EMDR group will receive 20 psychotherapeutic sessions of 60 min over 6 months. Substance use will be measured using the Timeline Followback Questionnaire, the Dependence Severity Scale and the Visual Analog Scale. Traumatic events will be measured by The Holmes-Rahe Life Stress Inventory, the Childhood Trauma Questionnaire Scale, the Global Assessment of Posttraumatic Stress Questionnaire, the Impact of Event Scale-Revised and the Dissociative Experiences Scale. Clinical symptomatology will be evaluated using the Hamilton Depression Rating Scale, the Young Mania Rating Scale and the Brief Psychiatric Rating Scale. Functionality will be assessed with the Functioning Assessment Short Test. All variables will be measured at baseline, post-treatment and 12 months as follow-up. Primary outcome: to test the efficacy of EMDR therapy in reducing the severity of substance use. The secondary outcomes: to test the efficacy in reducing trauma-related psychological symptoms and psychopathological symptoms and in improving overall functioning in patients with comorbid SUD and a history of psychological trauma. Conclusion: This study will provide evidence of whether EMDR therapy is effective in reducing addiction-related, trauma and clinical symptoms and in improving functionality in patients with SUD and a history of trauma. Clinical Trial Registration: The trial is registered at ClinicalTrials.gov, identifier: NCT03517592.

SUBMITTER: Valiente-Gomez A

PROVIDER: S-EPMC6428746 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A Multicenter Phase II Rater-Blinded Randomized Controlled Trial to Compare the Effectiveness of Eye Movement Desensitization Reprocessing Therapy vs. Treatment as Usual in Patients With Substance Use Disorder and History of Psychological Trauma: A Study Design and Protocol.

Valiente-Gómez Alicia A Moreno-Alcázar Ana A Radua Joaquim J Hogg Bridget B Blanco Laura L Lupo W W Pérez Víctor V Robles-Martínez Maria M Torrens Marta M Amann Benedikt L BL

Frontiers in psychiatry 20190315

<b>Background:</b> Psychological trauma has a strong negative impact on the onset, course and prognosis of substance use disorders (SUD). Few trauma-oriented treatment approaches have been trialed, but preliminary evidence exists of the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) therapy in improving clinical symptoms in SUD patients. <b>Objective:</b> To assess if EMDR therapy leads to: (1) reduced substance consumption; (2) an improvement in psychopathological and in traum ...[more]

PMID: 30930801

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Project description:ObjectiveEye movement desensitization and reprocessing (EMDR)-an evidence-based approach to eliminate emotional distress from traumatic experiences-was recently suggested for the treatment of chronic pain. The aim of this study was to estimate preliminary efficacy of a pain-focused EMDR intervention for the treatment of non-specific chronic back pain (CBP).DesignRandomized controlled pilot study.Methods40 non-specific CBP (nsCBP) patients reporting previous experiences of psychological trauma were consecutively recruited from outpatient tertiary care pain centers. After baseline assessment, patients were randomized to intervention or control group (1:1). The intervention group received 10 sessions standardized pain-focused EMDR in addition to treatment-as-usual (TAU). The control group received TAU alone. The primary outcome was preliminary efficacy, measured by pain intensity, disability, and treatment satisfaction from the patients' perspective. Clinical relevance of changes was determined according to the established recommendations. Assessments were conducted at the baseline, posttreatment, and at a 6-month follow-up. Intention-to-treat analysis with last observation carried forward method was used. Registered with http://ClinicalTrials.gov (NCT01850875).ResultsEstimated effect sizes (between-group, pooled SD) for pain intensity and disability were d = 0.79 (CI95%: 0.13, 1.42) and d = 0.39 (CI95%: -0.24, 1.01) posttreatment, and d = 0.50 (CI95%: 0.14, 1.12) and d = 0.14 (CI95%: -0.48, 0.76) at 6-month follow-up. Evaluation on individual patient basis showed that about 50% of the patients in the intervention group improved clinically relevant and also rated their situation as clinically satisfactory improved, compared to 0 patients in the control group.ConclusionThere is preliminary evidence that pain-focused EMDR might be useful for nsCBP patients with previous experiences of psychological trauma, with benefits for pain intensity maintained over 6 months.

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:Background: Eye movement desensitization and reprocessing [EMDR] is an innovative, evidence-based and effective psychotherapy for post-traumatic stress disorder [PTSD]. As with other psychotherapies, the effectiveness of EMDR contrasts with a limited knowledge of its underlying mechanism of action. In its relatively short life as a therapeutic option, EMDR has not been without controversy, in particular regarding the role of the bilateral stimulation as an active component of the therapy. The high prevalence of EMDR in clinical practice and the dramatic increase in EMDR research in recent years, with more than 26 randomized controlled trials published to date, highlight the need for a better understanding of its mechanism of action. Methods: We conducted a thorough systematic search of studies published until January 2018, using PubMed, ScienceDirect, Web of Knowledge and Scopus databases that examined the mechanism of action of EMDR or provided conclusions within the framework of current theoretical models of EMDR functioning. Results: Eighty-seven studies were selected for review and classified into three overarching models; (i) psychological models (ii) psychophysiological models and (iii) neurobiological models. The evidence available from each study was analyzed and discussed. Results demonstrated a reasonable empirical support for the working memory hypothesis and for the physiological changes associated with successful EMDR therapy. Recently, more sophisticated structural and functional neuroimaging studies using high resolution structural and temporal techniques are starting to provide preliminary evidence into the neuronal correlates before, during and after EMDR therapy. Discussion: Despite the increasing number of studies that published in recent years, the research into the mechanisms underlying EMDR therapy is still in its infancy. Studies in well-defined clinical and non-clinical populations, larger sample sizes and tighter methodological control are further needed in order to establish firm conclusions.

Project description:IntroductionEye Movement Desensitization and Reprocessing (EMDR) is a psychotherapeutic treatment resolving emotional distress caused by traumatic events. With EMDR, information processing is facilitated by eye movements (EM) during the recall of a traumatic memory (RECALL). The aim of this study is to investigate the effects of ocular movements of EMDR on the hemodynamics of the prefrontal cortex (PFC).Material and methodsTwo groups were recruited: a trial group (wEM) received a complete EMDR treatment, whereas a control group (woEM) received a therapy without EM. PFC hemodynamics was monitored by near-infrared spectroscopy during RECALL and during focusing on the worst image of the trauma (pre-RECALL). The parameters of oxy- (oxy-Hb), and deoxy-hemoglobin (deoxy-Hb) were acquired and analyzed in time domain, by calculating the slope within pre-RECALL and RECALL periods, and in the frequency domain, by calculating the mean power of oxy-Hb and deoxy-Hb in the very-low frequency (VLF, 20-40 mHz) and low frequency (LF, 40-140 mHz) bandwidths. We compared pre-RECALL with RECALL periods within subjects, and pre-RECALL and RECALL parameters of wEM with the corresponding of woEM.ResultsAn effect of group on mean slope of oxy-Hb and deoxy-Hb in pre-RECALL and oxy-Hb in RECALL periods was observed. wEM showed a lower percentage of positive angular coefficients during pre-RECALL with respect to RECALL, on the opposite of woEM. In the frequency domain, wEM had significant difference in oxy-Hb and deoxy-Hb LF of left hemisphere, whereas woEM showed no difference.Discussion and conclusionWe observed the effect of EM on PFC oxygenation during EMDR, since wEM subjects showed a mean increase of oxy-Hb during RECALL and a decrease during pre-RECALL, as opposed to woEM. Frequency analysis evidenced a reduction of activity of sympathetic nervous system in wEM group during pre-RECALL. Our outcomes revealed a different hemodynamics induced by eye movements in wEM with respect to woEM group.

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: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.

Dataset Information

A Multicenter Phase II Rater-Blinded Randomized Controlled Trial to Compare the Effectiveness of Eye Movement Desensitization Reprocessing Therapy vs. Treatment as Usual in Patients With Substance Use Disorder and History of Psychological Trauma: A Study Design and Protocol.

Publications

A Multicenter Phase II Rater-Blinded Randomized Controlled Trial to Compare the Effectiveness of Eye Movement Desensitization Reprocessing Therapy vs. Treatment as Usual in Patients With Substance Use Disorder and History of Psychological Trauma: A Study Design and Protocol.

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