将记忆支持干预纳入认知疗法能否改善抑郁症的治疗效果？一项随机对照试验的研究方案。
Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial.
作者信息
Harvey Allison G, Dong Lu, Lee Jason Y, Gumport Nicole B, Hollon Steven D, Rabe-Hesketh Sophia, Hein Kerrie, Haman Kirsten, McNamara Mary E, Weaver Claire, Martinez Armando, Notsu Haruka, Zieve Garret, Armstrong Courtney C
机构信息
Department of Psychology, University of California, Berkeley, 3210 Tolman Hall #1650, Berkeley, CA, 94720-1650, USA.
Vanderbilt University, Nashville, TN, USA.
出版信息
Trials. 2017 Nov 14;18(1):539. doi: 10.1186/s13063-017-2276-x.
BACKGROUND
The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT).
METHOD/DESIGN: Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3).
DISCUSSION
The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.
背景
记忆支持干预措施的开发是基于以下证据：（1）患者对治疗的记忆较差；（2）治疗记忆差与依从性差和预后较差相关；（3）通过使用记忆支持策略可将记忆障碍的影响降至最低；（4）改善治疗记忆可改善预后。本研究方案的目的是进行一项验证性疗效试验，以检验记忆支持干预措施是否能改善病程和功能结局。作为研究该方法下一步的“平台”，我们聚焦于重度抑郁症（MDD）和认知疗法（CT）。
方法/设计：患有MDD的成年人（n = 178，包括20%的潜在损耗）将被随机分配至CT + 记忆支持组或常规CT组，并在基线、治疗后以及6个月和12个月随访时（6FU和12FU）进行评估。我们将比较CT + 记忆支持与常规CT的效果，以确定新干预措施是否能改善病程并减少功能损害（目标1）。我们将确定患者对治疗的记忆是否介导治疗条件与结局之间的关系（目标2）。我们将评估先前报告的治疗反应较差的亚组是否会调节目标参与度（目标3）。
讨论
记忆支持干预措施已被开发为“跨诊断性”（适用于广泛的精神障碍）和“泛治疗性”（适用于广泛的治疗类型）。本研究方案通过测试针对重度抑郁症（MDD）和认知疗法（CT）的记忆支持干预措施，描述了治疗开发过程中的“下一步”。如果结果令人满意，未来的方向将是测试其在其他类型的干预措施和障碍以及其他环境中的适用性。
试验注册
ClinicalTrials.gov，ID：NCT01790919。于2016年10月6日注册。
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