Moreno-Alcázar Ana, Radua Joaquim, Landín-Romero Ramon, Blanco Laura, Madre Mercè, Reinares Maria, Comes Mercè, Jiménez Esther, Crespo Jose Manuel, Vieta Eduard, Pérez Victor, Novo Patricia, Doñate Marta, Cortizo Romina, Valiente-Gómez Alicia, Lupo Walter, McKenna Peter J, Pomarol-Clotet Edith, Amann Benedikt L
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.
Trials. 2017 Apr 4;18(1):160. doi: 10.1186/s13063-017-1910-y.
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.
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.
高达60%的双相情感障碍（BD）患者有创伤事件史，这与更严重的发作、更高的共病风险和更高的复发率相关。因此，针对BD的以创伤为重点的治疗策略是必要的，但目前研究较少。本研究的目的是检验聚焦于依从性、洞察力、躁狂症状去理想化、前驱症状和情绪稳定的眼动脱敏再处理（EMDR）疗法是否能降低BD患者的发作严重程度和复发率，并提高其认知表现和功能。
方法/设计：这是一项单盲、随机对照、多中心试验，将招募82名有创伤事件史的BD患者，并随机分配到两个治疗组之一：EMDR疗法组或支持性疗法组。两组患者将在6个月内接受20次心理治疗，每次60分钟。主要结局是12个月和24个月后，EMDR组的情感发作减少。作为次要结局，我们假设EMDR组的情感症状减少更多（通过双相抑郁评定量表、青年躁狂评定量表和为BD修改的临床总体印象量表测量），并且在认知状态、社会认知和功能方面表现更好（分别通过精神病学认知损害筛查量表、梅耶-萨洛维-卡鲁索情商测试和功能评估简短测试测量）。创伤事件将通过霍姆斯-拉赫生活压力量表、临床医生管理的创伤后应激障碍量表和事件影响量表进行评估。
本研究结果将为针对BD患者的特定EMDR方案是否能有效减少情感发作、情感症状以及功能、认知和创伤症状提供证据。
该试验已在ClinicalTrials.gov注册，标识符：NCT02634372。于2015年12月3日注册。
