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, 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, 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

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.

Keywords: Bipolar disorder; EMDR therapy; Psychological trauma; Supportive therapy; Treatment.

Figures

Fig. 1
Fig. 1
Flow diagram of enrollment, intervention and assessments. YMRS: Young Mania Rating Scale; BDRS: Bipolar Depression Rating Scale; CGI-BP-M: Clinical Global Impression, PTSD: Posttraumatic Stress Disorder; CAPS: Clinician Administered PTSD Scale; IES-R: Impact Event Scale; H-RLSI: The Holmes-Rahe Life Stress Inventory; SUD: Subjective Units of Distress; SCIP: Screen for Cognitive Impairment in Psychiatry; MSCEIT: The Mayer-Salovey-Caruso Emotional Intelligence Test; FAST:Functioning Assessment Short Test; CLQ-8: Client Satisfaction Questionnaire

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