Ferrari Gina R A, Becker Eni S, Smit Filip, Rinck Mike, Spijker Jan
Behavioural Science Institute, Radboud University Nijmegen, PO Box 9104, 6500 HE, Nijmegen, The Netherlands.
Pro Persona, Center for Mental Health Care, Nijmegen, The Netherlands.
BMC Psychiatry. 2016 Nov 3;16(1):370. doi: 10.1186/s12888-016-1085-1.
Despite the range of available, evidence-based treatment options for Major Depressive Disorder (MDD), the rather low response and remission rates suggest that treatment is not optimal, yet. Computerized attention bias modification (ABM) trainings may have the potential to be provided as cost-effective intervention as adjunct to usual care (UC), by speeding up recovery and bringing more patients into remission. Research suggests, that a selective attention for negative information contributes to development and maintenance of depression and that reducing this negative bias might be of therapeutic value. Previous ABM studies in depression, however, have been limited by small sample sizes, lack of long-term follow-up measures or focus on sub-clinical samples. This study aims at evaluating the long-term (cost-) effectiveness of internet-based ABM, as add-on treatment to UC in adult outpatients with MDD, in a specialized mental health care setting.
METHODS/DESIGN: This study presents a double-blind randomized controlled trial in two parallel groups with follow-ups at 1, 6, and 12 months, combined with an economic evaluation. One hundred twenty six patients, diagnosed with MDD, who are registered for specialized outpatient services at a mental health care organization in the Netherlands, are randomized into either a positive training (towards positive and away from negative stimuli) or a sham training, as control condition (continuous attentional bias assessment). Patients complete eight training sessions (seven at home) during a period of two weeks (four weekly sessions). Primary outcome measures are change in attentional bias (pre- to post-test), mood response to stress (at post-test) and long-term effects on depressive symptoms (up to 1-year follow-up). Secondary outcome measures include rumination, resilience, positive and negative affect, and transfer to other cognitive measures (i.e., attentional bias for verbal stimuli, cognitive control, positive mental imagery), as well as quality of life and costs.
This is the first study investigating the long-term effects of ABM in adult outpatients with MDD, alongside an economic evaluation. Next to exploring the mechanism underlying ABM effects, this study provides first insight into the effects of combining ABM and UC and the potential implementation of ABM in clinical practice.
Trialregister.nl, NTR5285 . Registered 20 July 2015.
尽管针对重度抑郁症（MDD）有一系列可用的循证治疗方案，但相当低的缓解率和治愈率表明目前的治疗仍非最佳。计算机化注意力偏差修正（ABM）训练有可能作为一种具有成本效益的干预措施，作为常规治疗（UC）的辅助手段，通过加快康复进程并使更多患者实现症状缓解。研究表明，对负面信息的选择性关注会导致抑郁症的发展和持续，减少这种负面偏差可能具有治疗价值。然而，先前关于抑郁症的ABM研究存在样本量小、缺乏长期随访措施或侧重于亚临床样本等局限性。本研究旨在评估在专业心理健康护理环境中，基于互联网的ABM作为成年MDD门诊患者UC的附加治疗的长期（成本）效益。
方法/设计：本研究是一项双盲随机对照试验，分为两个平行组，在1、6和12个月进行随访，并结合经济评估。126名被诊断为MDD且在荷兰一家心理健康护理机构注册接受专科门诊服务的患者，被随机分为积极训练组（朝向积极刺激并远离消极刺激）或假训练组作为对照条件（持续注意力偏差评估）。患者在两周内（每周四次）完成八次训练课程（七次在家中进行）。主要结局指标为注意力偏差的变化（测试前与测试后）、对压力的情绪反应（测试后）以及对抑郁症状的长期影响（长达1年的随访）。次要结局指标包括沉思、恢复力、积极和消极情绪、向其他认知指标的转移（即对言语刺激的注意力偏差、认知控制、积极心理意象），以及生活质量和成本。
这是第一项研究ABM对成年MDD门诊患者长期影响并进行经济评估的研究。除了探索ABM效果的潜在机制外，本研究还首次深入了解了ABM与UC联合使用的效果以及ABM在临床实践中的潜在应用。
Trialregister.nl，NTR5285。2015年7月20日注册。
