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

为针对抑郁症的亮光疗法（BLT）进行大型务实鼓励试验做准备的可行性试点

• 批准号: 10624317
• 负责人: GREGORY N CLARKE
• 金额: $ 12.15万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-02 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10624317
• 关键词: Address; Adherence; Adoption; Adult; Adverse effects; Affect; Antidepressive Agents; Anxiety; Basic Science; Benefits and Risks; Caring; Circadian Rhythms; Clinical; Cognitive Therapy; Communication; Complex; Confidence Intervals; Control Groups; Cost Analysis; Data; Depressive disorder; Development; Education; Effectiveness; Electronic Health Record; Employment; Enrollment; Evidence based treatment; Eye; Future; Health Services Accessibility; Healthcare Systems; Home; Insurance; Intervention; Letters; Life; Light; Major Depressive Disorder; Mediating; Mediator; Mental Depression; Mental Health; Meta-Analysis; Minor; Moods; Outcome; Participant; Patient Selection; Patient observation; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Photosensitivity; Phototherapy; Physical activity; Preparation; Price; Protocols documentation; Provider; Psychotherapy; Randomized; Readiness; Research; Sampling; Seasonal Affective Disorder; Seasons; Secure; Selective Serotonin Reuptake Inhibitor; Self Administration; Skin; Structure; Subgroup; Testing; Training; Travel; Treatment Effectiveness; Unipolar Depression; United States; Variant; Work; Writing; alternative treatment; arm; care systems; clinical care; clinical diagnosis; common treatment; cost; current pandemic; depressed patient; depressive symptoms; disability; economic evaluation; effectiveness evaluation; effectiveness trial; efficacy trial; evidence base; genetic pedigree; improved; improvement on sleep; insurance plan; intervention effect; motivational enhancement therapy; participant retention; physical conditioning; pragmatic trial; primary outcome; psychosocial; public health priorities; recruit; scaffold; secondary outcome; self-reported depression; side effect; social stigma; success; telehealth; telephone coaching; treatment as usual; uptake; usual care arm

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.

抽象的 抑郁症最常见的治疗方法是抗抑郁药（AD）和心理治疗 作为认知行为疗法（CBT）。但是，这些治疗只能在理想下产生适度的收益 情况。当现实世界患者以低率开始治疗时，这些影响就会进一步发出 依从性差或早期中止。这代表了支持抑郁症护理差距 开发和促进其他干预措施。这些替代疗法之一，明亮的光治疗 （BLT）已经确立了对季节性情感障碍（SAD）和非SAD抑郁症的有效性，相对较低 成本，几乎没有不利影响，但经常被忽略，在常规临床护理中几乎没有存在。 R34应用正在准备随后的大型务实试验，以检查Bright的有效性 抑郁症的光疗法（BLT）交付给典型的高度“脚手架”的现实世界中的患者 对照效率试验。我们将进行可行性飞行员，其中90名患者选择了新的 单极抑郁或SAD的临床诊断或PHQ-9分数> = 10，记录在健康计划中 电子健康记录（EHR）。参与者将被随机分配给：ARM 1：照常治疗（TAU）： “通常的护理服务”对照组（例如，广告，心理治疗；所有tau均已允许，并将记录为所有人 在所有情况下的参与者）；手臂2：tau +最小的BLT鼓励：tau加两个最小的书面 通讯（邮寄信，安全的EHR消息）宣传BLT作为有前途的待遇和概述 患者自发的步骤； ARM 2将不包括任何电话指导或依从性促销；或手臂3： tau +增强的BLT鼓励 +依从性促进：Tau加2-4个简短的电话，以鼓励BLT 使用，建议购买灯箱（LB），协助获得保险报销，教育正确 LB使用，并根据需要提供动机访谈（MI）以促进依从性。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手臂之间的对比度 2+3 vs. ARM 1。我们将进行探索性分析，为将来的全功率试验做准备。我们将检查 其他次要结果，包括动画，残疾和情绪季节性以及其他次要对比； 例如，ARM 2 vs ARM 3。我们还将检查节奏效应；亚组中BLT效应的变化（例如， 那些接收与未接受tau抗抑郁药的人）；我们将检查BLT和MI的机制 通过包括归一化昼夜节律，改善睡眠和 增加体育锻炼（用于BLT），并准备变化（用于MI）。该飞行员将产生可行性产品 为了协助成功进行随后的全面试验：招聘成功的估计，参与 保留和遵守BLT方案；依从性促进方案的完善；和一个估计 （具有广泛的置信区间）BLT有效性。