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

Ana Moreno-Alcázar,Ana Moreno-Alcázar,Ana Moreno-Alcázar,Ana Moreno-Alcázar,Mercè Madre,Peter J Mckenna,Peter J Mckenna,Joaquim Radua,Victor Pérez,Walter Lupo,Laura Blanco,Eduard Vieta,Eduard Vieta,Eduard Vieta,Romina Cortizo,Patricia Novo,Maria Reinares,Marta Doñate,Alicia Valiente-Gómez,Benedikt L Amann,Benedikt L Amann,Benedikt L Amann,Benedikt L Amann,Benedikt L Amann,Jose Manuel Crespo,Jose Manuel Crespo,Jose Manuel Crespo,Esther Jiménez,Esther Jiménez,Esther Jiménez,Mercè Comes,Mercè Comes,Mercè Comes,Edith Pomarol-Clotet,Edith Pomarol-Clotet,Ramon Landín-Romero

doi:10.1186/s13063-017-1910-y

Abstract

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.

Highlights

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
R software will be used to carry out the statistical analyses. This trial is based on our first preliminary randomized controlled trial (RCT) of Eye Movement Desensitization and Reprocessing (EMDR) in traumatized bipolar patients, with positive results in affective and trauma-related symptoms in the EMDR group when compared to treatment as usual [24]
The main goal of the current study is to test in a large multicenter sample of bipolar I and II patients, if a newly developed, specific EMDR protocol for BD [25], compared to supportive therapy (ST), can reduce affective relapses, improve affective and trauma-related symptoms and result in a better performance of cognition and functioning

Summary

Introduction

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. The disorder is conventionally characterized as being episodic in nature, with full recovery between periods of mania and depression, recent data suggest that many bipolar patients do not obtain a complete remission but continue to experience subsyndromal manic or depressive symptoms [2]. This is a clinically important issue since (1) subsyndromal symptoms are associated with a higher risk of relapses and poorer social functioning [3] and (2) interepisode affective instability seems to be refractory to pharmacological treatment [4]. Despite the everyday use in clinical practice of both types of intervention, almost 70% of BD patients suffer from at least one affective relapse within 2 to 4 years [7,8,9]

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