Huffman Jeffery C, Albanese Ariana M, Campbell Kirsti A, Celano Christopher M, Millstein Rachel A, Mastromauro Carol A, Healy Brian C, Chung Wei-Jean, Januzzi James L, Collins Linda M, Park Elyse R
1 Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
2 Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.
Clin Trials. 2017 Apr;14(2):128-139. doi: 10.1177/1740774516673365. Epub 2017 Jan 12.
Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome.
In this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation.
The Positive Emotions after Acute Coronary Events III study is an optimization study (planned N = 128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2 × 2 × 2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16 weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises, duration of the intervention, and inclusion of booster sessions) from a full factorial model controlling for baseline activity. Similar analyses will be performed on self-report measures and objectively-measured medication adherence over 16 weeks. We hypothesize that the combined positive psychology and motivational interviewing intervention, weekly exercises, and booster sessions will be associated with superior physical activity.
Thus far, 78 participants have enrolled, with 72% of all possible exercises fully completed by participants.
The Positive Emotions after Acute Coronary Events III study will help to determine the optimal content, intensity, and duration of a positive psychology intervention in post-acute coronary syndrome patients prior to testing in a randomized trial. This study is novel in its use of a factorial design within the multiphase optimization strategy framework to optimize a behavioral intervention and the use of a positive psychology intervention to promote physical activity in high-risk cardiac patients.
积极的心理建构,如乐观主义,与更多地参与心脏健康行为以及改善心脏预后相关。以心理健康为目标的积极心理学干预措施,可能是改善高危心脏病患者健康行为的一种有前景的方法。然而,尚无研究评估积极心理学干预能否促进急性冠状动脉综合征后的身体活动。
在本文中,我们将描述一项新颖的析因设计研究的方法,以帮助开发针对急性冠状动脉综合征患者的基于积极心理学的干预措施,并旨在提供关于研究实施的初步可行性数据。
急性冠状动脉事件后积极情绪III研究是一项优化研究(计划样本量N = 128),隶属于一个更大的多阶段优化策略迭代治疗开发项目。急性冠状动脉事件后积极情绪III的目标是确定基于积极心理学的干预措施的理想组成部分,以改善急性冠状动脉综合征后的身体活动。采用2×2×2析因设计,急性冠状动脉事件后积极情绪III旨在:(1)评估单独使用积极心理学练习或与动机性访谈相结合的相对优点;(2)评估每周或每天完成积极心理学练习是否最佳;(3)确定强化课程的效用。该研究的主要结局指标是16周时通过加速度计测量的中度至剧烈身体活动。次要结局指标包括心理、功能和与依从性相关的行为结局,以及可行性和可接受性指标。对于主要研究结局,我们将使用具有随机截距(以考虑重复测量)的混合效应模型,从控制基线活动的全析因模型中评估每个组成部分(练习中纳入动机性访谈、干预持续时间以及纳入强化课程)的主要效应。将对16周内的自我报告测量和客观测量的药物依从性进行类似分析。我们假设积极心理学与动机性访谈相结合的干预、每周练习和强化课程将与更好的身体活动相关。
到目前为止,已有78名参与者入组,参与者完成了所有可能练习的72%。
急性冠状动脉事件后积极情绪III研究将有助于在随机试验测试之前确定急性冠状动脉综合征后患者积极心理学干预的最佳内容、强度和持续时间。本研究在多阶段优化策略框架内使用析因设计来优化行为干预以及使用积极心理学干预来促进高危心脏病患者的身体活动方面具有创新性。