Abstract

Introduction

Preferences play an important role in determining insomnia treatment outcomes, but the validity of patient choice is rarely assessed. Uninformed preferences can lead to decisional conflict, which can negatively impact on treatment initiation, adherence, and subsequent outcomes. The current study aims to evaluate the impact of integrating a patient decision-aid as part of a pragmatic clinical trial and to identify baseline covariates associated with clinically significant decisional conflict (CSDC).

Methods

Secondary analysis of an ongoing pragmatic clinical trial for a two-stage cognitive behavioral therapy for insomnia (CBT-I) intervention was undertaken. Participants were referred from primary care clinics in Quebec City, Canada. Upon enrolment, participants were guided by a decision-aid, outlining the risks and benefits of prospective treatment options, when selecting their preferred arm of treatment in Phase 1. Options included SHUTi, SHUTi combined with an existing medication or continuing usual treatment with medication alone. Participants also completed a battery of sleep and mental health measures at baseline. Prior to treatment initiation, the 4-item SURE (Sure of myself; Understand information; Risk-Benefit ratio; Encouragement) scale was administered to screen for CSDC. Relationships between CSDC and baseline covariates were explored using Pearson correlations.

Results

Of the 55 participants initially enrolled, 94.5% (n=52) of participants preferentially selected SHUTi, either as sole treatment (n=24) or in combination with an existing medication (n=28), over usual treatment with medication alone (n=3). Overall, CSDC was only reported by 5.5% (n=3) of the sample population, with no group differences observed, suggesting effective clarification of treatment options through the decision-aid. Interestingly, higher SURE scores (i.e. less decisional conflict) were negatively correlated with depressive symptoms (r= -0.295, n= 55, p= 0.029) and anxiety symptoms (r= -0.301, n= 55, p= 0.026). Correlations with age, insomnia symptoms, duration of insomnia and fatigue were not statistically significant.

Conclusion

The patient decision-aid appeared to resolve decisional conflict for 94.5% (n=52) of participants. Findings allude to the potential influence of emotional status on information processing pathways in an insomnia context, warranting further research.

Support

Research supported by a grant from the Canadian Institutes of Health Research (CIHR-IRSC:0441002152).

中文翻译：

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0512选择失眠治疗时患者决策助手的影响以及与决策冲突相关的因素：正在进行的实用临床试验的初步结果

摘要

介绍

偏好在确定失眠治疗结果中起着重要作用，但很少评估患者选择的有效性。不了解情况的偏好会导致决策冲突，从而可能对治疗的开始，依从性和后续结果产生负面影响。当前的研究旨在评估将患者决策辅助作为务实的临床试验的一部分的影响，并确定与临床上重大决策冲突（CSDC）相关的基线协变量。

方法

对正在进行的针对失眠的两阶段认知行为疗法（CBT-1）干预的实用临床试验进行了二次分析。参与者从加拿大魁北克市的初级保健诊所转诊。在入组时，参与者将在决策援助的指导下，概述在第1阶段选择其首选治疗方式时的前瞻性治疗选择的风险和收益。选择包括SHUTi，SHUTi与现有药物联合或仅使用药物继续常规治疗。参与者还在基线时完成了一系列睡眠和心理健康措施。在开始治疗之前，先对4项SURE（我确定；了解信息；风险收益比；鼓励）量表进行筛查CSDC。

结果

在最初招募的55名参与者中，有94.5％（n = 52）的参与者优先选择SHUTi，作为单独治疗（n = 24）或与现有药物联合使用（n = 28），而不是单独使用药物的常规治疗（n = 3）。总体而言，仅占样本人群的5.5％（n = 3）报告了CSDC，未观察到组间差异，这表明通过决策辅助可以有效地阐明治疗方案。有趣的是，较高的SURE评分（即较少的决策冲突）与抑郁症状（r = -0.295，n = 55，p = 0.029）和焦虑症状（r = -0.301，n = 55，p = 0.026）负相关。与年龄，失眠症状，失眠持续时间和疲劳的相关性无统计学意义。

结论

患者的决策帮助似乎可以解决94.5％（n = 52）的参与者的决策冲突。这些发现暗示了失眠情况下情绪状态对信息处理途径的潜在影响，值得进一步研究。

支持

该研究得到了加拿大卫生研究院（CIHR-IRSC：0441002152）的资助。