Investigating the (cost-) effectiveness of attention bias modification (ABM) for outpatients with major depressive disorder (MDD): a randomized controlled trial protocol.

Investigating the (cost-) effectiveness of attention bias modification (ABM) for outpatients with major depressive disorder (MDD): a randomized controlled trial protocol.
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DOI:
10.1186/s12888-016-1085-1
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发表时间:
2016-11-03
期刊:
影响因子:
4.4
通讯作者:
Spijker J
Spijker J
中科院分区:
医学2区
文献类型:
--
作者:
Ferrari GR;Becker ES;Smit F;Rinck M;Spijker J

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尽管有一系列针对重度抑郁症(MDD)的循证治疗方案,但相当低的应答率和缓解率表明,治疗还不是最佳的。计算机化的注意力偏差修正(ABM)培训可能有潜力作为常规护理(UC)的辅助措施,通过加速恢复和使更多患者缓解来提供具有成本效益的干预。研究表明,对负面信息的选择性关注有助于抑郁症的发展和维持,减少这种负面偏见可能具有治疗价值。然而,以往的ABM抑郁症研究受到样本量小、缺乏长期随访措施或关注亚临床样本的限制。本研究的目的是在专门的精神卫生保健环境中,评估基于互联网的ABM作为MDD成人门诊患者UC的附加治疗的长期(成本)效果。本研究是一项双盲随机对照试验,分为两个平行组,分别在1个月、6个月和12个月进行随访,并结合经济学评价。126名诊断为MDD的患者在荷兰的一家精神卫生保健机构注册了专门的门诊服务,他们被随机分为积极训练(朝向积极和远离消极刺激)或假训练,作为对照条件(持续注意力偏差评估)。患者在两周的时间内完成八次训练(七次在家)(每周四次)。主要结果测量是注意力偏差的变化(前到后测试),对压力的情绪反应(后测试)和对抑郁症状的长期影响(长达1年的随访)。次要结果指标包括反刍、复原力、积极和消极影响,以及转移到其他认知指标(即,对言语刺激的注意力偏差、认知控制、积极的心理意象),以及生活质量和成本。这是第一个研究ABM在成人门诊MDD患者中的长期效果,同时进行经济评估。在探索ABM效应的机制基础上,本研究首次深入了解了ABM和UC的联合效应以及ABM在临床实践中的潜在应用。Trialregister.nl,NTR5285. 2015年7月20日注册。
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. 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.
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