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.
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.
authors.affiliation: FIDMAG Germanes Hospitalàries Research Foundation, Dr. Antoni Pujadas 38, 08830, Sant Boi de Llobregat, Spain. amoreno@fidmag.com.|Centre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del Mar, Barcelona, Spain. amoreno@fidmag.com.|IMIM (Institut Hospital del Mar d'Investigacions Mèdiques), Barcelona, Spain. amoreno@fidmag.com.|Department of Psychiatry, Autonomous University Barcelona, Cerdanyola, Spain. amoreno@fidmag.com.
authors.forename: Ana
authors.identifier: 0000-0002-3392-5590
authors.initials: A
authors.lastname: Moreno-Alcázar
authors.affiliation: FIDMAG Germanes Hospitalàries Research Foundation, Dr. Antoni Pujadas 38, 08830, Sant Boi de Llobregat, Spain.|Division of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.|Centre for Psychiatric Research and Education, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Joaquim
authors.initials: J
authors.lastname: Radua
authors.affiliation: Neuroscience Research Australia, Sydney, NSW, Australia.|Macquairie University, Sydney, NSW, Australia.|School of Medical Sciences, the University of New South Wales, Sydney, NSW, Australia.
authors.forename: Ramon
authors.initials: R
authors.lastname: Landín-Romero
authors.affiliation: Benito Menni Complex Assistencial en Salut Mental, Sant Boi de Llobregat, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Blanco
authors.affiliation: Benito Menni Complex Assistencial en Salut Mental, Sant Boi de Llobregat, Spain.
authors.forename: Mercè
authors.initials: M
authors.lastname: Madre
authors.affiliation: Hospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Reinares
authors.affiliation: Hospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.
authors.forename: Mercè
authors.initials: M
authors.lastname: Comes
authors.affiliation: Hospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.
authors.forename: Esther
authors.initials: E
authors.lastname: Jiménez
authors.affiliation: CIBERSAM (Centro de Investigación Biomédica en Red de Salud Mental), Madrid, Spain.|Bellvitge University Hospital, Psychiatry Department, Bellvitge Biomedical Research Institute (IDIBELL), Neurosciences Group-Psychiatry and Mental Health, Barcelona, Spain.
authors.forename: Jose Manuel
authors.initials: JM
authors.lastname: Crespo
authors.affiliation: Hospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.|CIBERSAM (Centro de Investigación Biomédica en Red de Salud Mental), Madrid, Spain.
authors.forename: Eduard
authors.initials: E
authors.lastname: Vieta
authors.affiliation: Centre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del Mar, Barcelona, Spain.|IMIM (Institut Hospital del Mar d'Investigacions Mèdiques), Barcelona, Spain.|Department of Psychiatry, Autonomous University Barcelona, Cerdanyola, Spain.|CIBERSAM (Centro de Investigación Biomédica en Red de Salud Mental), Madrid, Spain.
authors.forename: Victor
authors.initials: V
authors.lastname: Pérez
authors.affiliation: Centre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del Mar, Barcelona, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Novo
authors.affiliation: Centre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del Mar, Barcelona, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Doñate
authors.affiliation: Centre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del Mar, Barcelona, Spain.
authors.forename: Romina
authors.initials: R
authors.lastname: Cortizo
authors.affiliation: Centre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del Mar, Barcelona, Spain.
authors.forename: Alicia
authors.initials: A
authors.lastname: Valiente-Gómez
authors.affiliation: Clínica Logos, Barcelona, Spain.
authors.forename: Walter
authors.initials: W
authors.lastname: Lupo
authors.affiliation: FIDMAG Germanes Hospitalàries Research Foundation, Dr. Antoni Pujadas 38, 08830, Sant Boi de Llobregat, Spain.|CIBERSAM (Centro de Investigación Biomédica en Red de Salud Mental), Madrid, Spain.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: McKenna
authors.affiliation: FIDMAG Germanes Hospitalàries Research Foundation, Dr. Antoni Pujadas 38, 08830, Sant Boi de Llobregat, Spain.|CIBERSAM (Centro de Investigación Biomédica en Red de Salud Mental), Madrid, Spain.
authors.forename: Edith
authors.initials: E
authors.lastname: Pomarol-Clotet
authors.affiliation: FIDMAG Germanes Hospitalàries Research Foundation, Dr. Antoni Pujadas 38, 08830, Sant Boi de Llobregat, Spain.|Centre Forum Research Unit, Institute of Neuropsychiatry and Addictions (INAD) Hospital del Mar, Barcelona, Spain.|IMIM (Institut Hospital del Mar d'Investigacions Mèdiques), Barcelona, Spain.|Department of Psychiatry, Autonomous University Barcelona, Cerdanyola, Spain.|CIBERSAM (Centro de Investigación Biomédica en Red de Salud Mental), Madrid, Spain.
authors.forename: Benedikt L
authors.initials: BL
authors.lastname: Amann
mesh_terms: D000293:Adolescent; D000328:Adult; D000339:Affect; D000368:Aged; D001714:Bipolar Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D003071:Cognition; D057169:Eye Movement Desensitization Reprocessing; D005260:Female; D006801:Humans; D007361:Intelligence Tests; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D012008:Recurrence; D012107:Research Design; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013030:Spain; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014947:Wounds and Injuries / Q000175:diagnosis / Q000523:psychology*; D055815:Young Adult
keywords: Bipolar disorder; EMDR therapy; Psychological trauma; Supportive therapy; Treatment