1. 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
- Author
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José Manuel Crespo, Peter J. McKenna, María Reinares, Esther Jiménez, Walter Lupo, Eduard Vieta, Joaquim Radua, Víctor Pérez, Mercè Comes, Ramon Landin-Romero, Mercè Madre, Alicia Valiente-Gómez, Romina Cortizo, Laura Blanco, Marta Doñate, Benedikt L. Amann, Edith Pomarol-Clotet, Patricia Novo, Ana Moreno-Alcázar, and Universitat de Barcelona
- Subjects
Male ,Bipolar Disorder ,Time Factors ,Eye Movement Desensitization Reprocessing ,medicine.medical_treatment ,Medicine (miscellaneous) ,Severity of Illness Index ,law.invention ,Pathological psychology ,Study Protocol ,0302 clinical medicine ,Cognition ,Randomized controlled trial ,Clinical Protocols ,law ,Recurrence ,Surveys and Questionnaires ,Eye movement desensitization and reprocessing ,Psychological trauma ,Manic-depressive illness ,Pharmacology (medical) ,Single-Blind Method ,Intelligence Tests ,lcsh:R5-920 ,Trastorn bipolar ,EMDR therapy ,Middle Aged ,Treatment Outcome ,Research Design ,Female ,lcsh:Medicine (General) ,Adult ,medicine.medical_specialty ,Adolescent ,Bipolar disorder ,Relapse prevention ,Young Mania Rating Scale ,Supportive therapy ,03 medical and health sciences ,Young Adult ,medicine ,Psicosi maniacodepressiva ,Humans ,Psychiatry ,Aged ,Psychiatric Status Rating Scales ,business.industry ,medicine.disease ,030227 psychiatry ,Psicopatologia ,Treatment ,Affect ,Supportive psychotherapy ,Spain ,Clinical Global Impression ,Wounds and Injuries ,business ,030217 neurology & neurosurgery - Abstract
Altres ajuts: Plan Nacional 2013-2016 with a Miguel Servet Research Contract (MS14/00041). We acknowledge also the generous support by the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Madrid, Spain. 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: . Registered on 3 December 2015. The online version of this article (doi:10.1186/s13063-017-1910-y) contains supplementary material, which is available to authorized users.
- Published
- 2017