Feasibility pilot in preparation for large pragmatic encouragement trial of Bright Light Therapy (BLT) for depression

摘要 最常见的抑郁症治疗方法是抗抑郁药物(ADS)和心理疗法，如 作为认知行为疗法(CBT)。然而，在理想的情况下，这些治疗只能产生适度的益处。 情况。当现实世界的患者以较低的比率开始治疗时，这些影响会进一步受到侵蚀 服药依从性差或过早停药。这代表着抑郁症护理缺口，支持 制定和推广其他干预措施。其中一种替代疗法是强光疗法 已经确定对季节性情感障碍(SAD)和非SAD抑郁有效的(BLT)相对较低 成本高，副作用小--但经常被忽视，在常规临床护理中几乎不存在。这 R34的应用正在为随后的大规模、务实的试验做准备，以检验光明的效果 光疗法(BLT)用于抑郁症，当提供给现实世界中的患者时，几乎不会有典型的高度 对照疗效试验。我们将进行一项可行性试验，样本为90名患有新的 单相抑郁或SAD的临床诊断，或PHQ-9评分=10，记录在HealthPlan的 电子健康记录(EHR)。参与者将随机分为两组：第一组：照常治疗(TAU)：A “日常护理服务”对照组(如ADS、心理治疗；允许所有TAU，并将对所有人进行记录 所有条件下的参与者)；手臂2：tau+最小BLT鼓励：tau加两个最低限度的书面 宣传(邮寄信件、安全电子病历信息)将BLT宣传为一种有前途的治疗方法并概述 患者自行启动的步骤；ARM 2将不包括任何电话指导或遵从性宣传；或ARM 3： Tau+增强型BLT鼓励+遵守推广：Tau加2-4个简短电话以鼓励BLT 使用，建议购买灯箱，帮助获得保险报销，教育正确 使用LB，并根据需要提供激励性访谈(MI)以促进遵守。主要结果是 PHQ-9自我报告的抑郁症状；BLT有效性的主要测试是ARM之间的对比 2+3 VS ARM 1。我们将进行探索性分析，为未来的全面试验做准备。我们将研究 其他次要结果包括焦虑、残疾和情绪季节性，以及其他次要对比； 例如，ARM 2与ARM 3。我们还将检查调节效应；BLT效应在亚组中的变化(例如， 那些接受TAU抗抑郁药物的患者与未接受TAU抗抑郁药物的患者相比)；我们将研究BLT和MI的机制 通过候选中介的干预效果，包括正常化的昼夜节律，改善的睡眠，以及 增加身体活动(对于BLT)，并为变化做好准备(对于MI)。这项试点将生产出可行性产品 协助成功进行后续的全面试验：估计招募成功，参与者 保留和遵守BLT协议；改进遵守促进协议；以及估计 BLT有效性的(具有宽的可信区间)。

ABSTRACT The most common treatments for depression are antidepressant medications (ADs) and psychotherapies such as cognitive behavioral therapy (CBT). However, these treatments yield only moderate benefits under ideal circumstances. These effects are further eroded when real world patients initiate treatments at low rates and have poor adherence or early discontinuation. This represents a depression care gap that supports the development and promotion of other interventions. One of these alternative treatments, bright light therapy (BLT), has established efficacy for seasonal affective disorder (SAD) and non-SAD depression, is relatively low cost, and has few adverse effects—but is often overlooked and has little presence in routine clinical care. This R34 application is in preparation for a subsequent large, pragmatic trial to examine the effectiveness of bright light therapy (BLT) for depression when delivered to real-world patients with little “scaffolding” typical of highly controlled efficacy trials. We will conduct a feasibility pilot with a sample of 90 patients selected with a new clinical diagnosis of unipolar depression or SAD, or a PHQ-9 score >= 10, recorded in the healthplan’s electronic health record (EHR). Participants will be randomized to either: Arm 1: Treatment as Usual (TAU): A “usual care services” control group (e.g., ADs, psychotherapy; all TAU is permitted and will be recorded for all participants in all conditions); Arm 2: TAU + Minimal BLT Encouragement: TAU plus two minimal written communications (mailed letter, secure EHR message) promoting BLT as a promising treatment and outlining steps for patients to self-initiate; Arm 2 will not include any phone coaching or adherence promotion; or Arm 3: TAU + Enhanced BLT Encouragement + Adherence Promotion: TAU plus 2-4 brief calls to encourage BLT use, advise on purchase of a light box (LB), assist with obtaining insurance reimbursement, educate for correct LB use, and provide motivational interviewing (MI) as needed to promote adherence. The primary outcome is PHQ-9 self-reported depression symptoms; the primary test of BLT effectiveness is the contrast between Arms 2+3 vs. Arm 1. We will conduct exploratory analyses to prepare for a future fully-powered trial. We will examine other secondary outcomes including anxiety, disability, and mood seasonality, and other secondary contrasts; e.g., Arm 2 vs Arm 3. We will also examine moderation effects; variation of BLT effects in subgroups (e.g., those receiving vs. not receiving TAU antidepressants); and we will examine mechanisms of BLT and MI intervention effects via candidate mediators including normalized circadian rhythm, improved sleep, and increased physical activity (for BLT), and readiness for change (for MI). This pilot will yield feasibility products to assist with successful conduct of a subsequent full trial: estimates of recruitment success, participant retention, and adherence with BLT protocol; refinement of the adherence promotion protocol; and an estimate (with wide confidence intervals) of BLT effectiveness.