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Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial.

ABSTRACT: Up 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.This 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.The 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.The trial is registered at ClinicalTrials.gov, identifier: NCT02634372 . Registered on 3 December 2015.

SUBMITTER: Moreno-Alcazar A

PROVIDER: S-EPMC5379519 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial.

Moreno-Alcázar Ana A Radua Joaquim J Landín-Romero Ramon R Blanco Laura L Madre Mercè M Reinares Maria M Comes Mercè M Jiménez Esther E Crespo Jose Manuel JM Vieta Eduard E Pérez Victor V Novo Patricia P Doñate Marta M Cortizo Romina R Valiente-Gómez Alicia A Lupo Walter W McKenna Peter J PJ Pomarol-Clotet Edith E Amann Benedikt L BL

Trials 20170404 1

<h4>Background</h4>Up 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 m ...[more]

PMID: 28376919

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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: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: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:BackgroundParents of children with a rare progressive life-limiting illness are at risk for parental posttraumatic stress disorder (PTSD). Studies on the treatment of parental PTSD with eye movement and desensitization reprocessing (EMDR) therapy in pediatric practice are lacking. Therefore this study aims to evaluate the feasibility and effectiveness of time-limited EMDR therapy in reducing PTSD symptoms, comorbid psychological symptoms, distress, and parental stress.MethodsMono-center randomized clinical trial conducted between February 2020 and April 2021. Fourteen parents (N = 7 mothers, N = 7 fathers) of mucopolysaccharidosis type III patients reporting PTSD symptoms on a (sub)clinical level were assigned to EMDR or a wait-list control condition followed by EMDR. Four sessions of EMDR (each 90 min) divided over two half-days were offered. Measurements were conducted at baseline, post-treatment/post-waitlist, and 3-months post-treatment. The primary outcome was PTSD symptom severity (PTSD Check List for DSM-5). Secondary outcomes included comorbid psychological symptoms (Brief Symptom Inventory), distress (Distress Thermometer for Parents) and parenting stress (Parenting Stress Questionnaire). Between-group comparisons pre-to-post treatment (N = 7 EMDR vs. N = 7 wait-list) and within-group comparisons (EMDR, N = 14) from pre-to-post treatment and from pre-treatment to 3-months follow-up were carried out per intent-to-treat linear mixed model analyses.ResultsCompared to wait-list, EMDR resulted in a significant reduction on total PTSD symptom severity (d = 1.78) and on comorbid psychological symptoms, distress and parenting stress (d = .63-1.83). Within-group comparisons showed a significant effect on all outcomes at post-treatment (d = 1.04-2.21) and at 3-months follow-up (d = .96-2.30) compared to baseline. EMDR was well-tolerated, associated with a low drop-out rate, a high therapy adherence and no adverse events.ConclusionTime-limited EMDR reduces PTSD symptoms, psychological comorbidity, distress and parenting stress in parents of children with a rare progressive life-limiting illness. This treatment was feasible for these overburdened parents. Recurrent monitoring of PTSD symptoms, and, if needed, offering this time-limited type of trauma treatment should be introduced in everyday pediatric practice. Trial registration Netherlands Trial Register, NL8496. Registered 01-04-2020, https://trialsearch.who.int/Trial2.aspx?TrialID=NL8496 .

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.

Dataset Information

Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial.

Publications

Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial.

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