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 Background 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 sca...

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Main Authors: Ana Moreno-Alcázar, Joaquim Radua, Ramon Landín-Romero, Laura Blanco, Mercè Madre, Maria Reinares, Mercè Comes, Esther Jiménez, Jose Manuel Crespo, Eduard Vieta, Victor Pérez, Patricia Novo, Marta Doñate, Romina Cortizo, Alicia Valiente-Gómez, Walter Lupo, Peter J. McKenna, Edith Pomarol-Clotet, Benedikt L. Amann
Format: Article
Language:English
Published: BMC 2017-04-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-017-1910-y
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author Ana Moreno-Alcázar
Joaquim Radua
Ramon Landín-Romero
Laura Blanco
Mercè Madre
Maria Reinares
Mercè Comes
Esther Jiménez
Jose Manuel Crespo
Eduard Vieta
Victor Pérez
Patricia Novo
Marta Doñate
Romina Cortizo
Alicia Valiente-Gómez
Walter Lupo
Peter J. McKenna
Edith Pomarol-Clotet
Benedikt L. Amann
author_facet Ana Moreno-Alcázar
Joaquim Radua
Ramon Landín-Romero
Laura Blanco
Mercè Madre
Maria Reinares
Mercè Comes
Esther Jiménez
Jose Manuel Crespo
Eduard Vieta
Victor Pérez
Patricia Novo
Marta Doñate
Romina Cortizo
Alicia Valiente-Gómez
Walter Lupo
Peter J. McKenna
Edith Pomarol-Clotet
Benedikt L. Amann
author_sort Ana Moreno-Alcázar
collection DOAJ
description Abstract Background 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. Methods/design 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. Discussion 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. Trial registration The trial is registered at ClinicalTrials.gov, identifier: NCT02634372 . Registered on 3 December 2015.
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spelling doaj.art-ed60064e468f4b1eaddb7558310467072022-12-21T23:02:17ZengBMCTrials1745-62152017-04-0118111010.1186/s13063-017-1910-yEye 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 trialAna Moreno-Alcázar0Joaquim Radua1Ramon Landín-Romero2Laura Blanco3Mercè Madre4Maria Reinares5Mercè Comes6Esther Jiménez7Jose Manuel Crespo8Eduard Vieta9Victor Pérez10Patricia Novo11Marta Doñate12Romina Cortizo13Alicia Valiente-Gómez14Walter Lupo15Peter J. McKenna16Edith Pomarol-Clotet17Benedikt L. Amann18FIDMAG Germanes Hospitalàries Research FoundationFIDMAG Germanes Hospitalàries Research FoundationNeuroscience Research AustraliaBenito Menni Complex Assistencial en Salut MentalBenito Menni Complex Assistencial en Salut MentalHospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAMHospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAMHospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAMCIBERSAM (Centro de Investigación Biomédica en Red de Salud Mental)Hospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAMCentre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del MarCentre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del MarCentre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del MarCentre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del MarCentre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del MarClínica LogosFIDMAG Germanes Hospitalàries Research FoundationFIDMAG Germanes Hospitalàries Research FoundationFIDMAG Germanes Hospitalàries Research FoundationAbstract Background 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. Methods/design 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. Discussion 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. Trial registration The trial is registered at ClinicalTrials.gov, identifier: NCT02634372 . Registered on 3 December 2015.http://link.springer.com/article/10.1186/s13063-017-1910-yBipolar disorderEMDR therapySupportive therapyPsychological traumaTreatment
spellingShingle Ana Moreno-Alcázar
Joaquim Radua
Ramon Landín-Romero
Laura Blanco
Mercè Madre
Maria Reinares
Mercè Comes
Esther Jiménez
Jose Manuel Crespo
Eduard Vieta
Victor Pérez
Patricia Novo
Marta Doñate
Romina Cortizo
Alicia Valiente-Gómez
Walter Lupo
Peter J. McKenna
Edith Pomarol-Clotet
Benedikt L. Amann
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
Trials
Bipolar disorder
EMDR therapy
Supportive therapy
Psychological trauma
Treatment
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Bipolar disorder
EMDR therapy
Supportive therapy
Psychological trauma
Treatment
url http://link.springer.com/article/10.1186/s13063-017-1910-y
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