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: 10416085
• 负责人: GREGORY N CLARKE
• 金额: $ 24.3万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10416085
• 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; 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 of activation protein; Mental Depression; Mental Health; Meta-Analysis; Minor; Moods; Outcome; Participant; Patient observation; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Photosensitivity; Phototherapy; Physical activity; Preparation; Price; Protocols documentation; Provider; Psychotherapy; Randomized; Readiness; Research; Sampling; Seasonal Affective Disorder; Secure; Selective Serotonin Reuptake Inhibitor; Self Administration; Skin; Sleep; Structure; Subgroup; Telephone; Testing; Training; Travel; Treatment Effectiveness; Unipolar Depression; United States; Variant; Work; alternative treatment; arm; care systems; clinical care; clinical diagnosis; common treatment; cost; depressed patient; depressive symptoms; disability; economic evaluation; effectiveness trial; efficacy trial; evidence base; genetic pedigree; improved; insurance plan; intervention effect; motivational enhancement therapy; pandemic disease; participant retention; physical conditioning; pragmatic trial; primary outcome; psychosocial; public health priorities; recruit; scaffold; secondary outcome; self-reported depression; side effect; social stigma; success; telehealthcare; 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.

摘要 抑郁症最常见的治疗方法是抗抑郁药物（AD）和心理疗法， 认知行为疗法（CBT）。然而，在理想的情况下，这些治疗仅产生中等效益。 情节当真实的世界患者以低速率开始治疗时， 依从性差或提前停药。这代表了一个抑郁症护理差距，支持 制定和促进其他干预措施。这些替代疗法之一，明亮的光线疗法 (BLT)对季节性情感障碍（SAD）和非SAD抑郁症的疗效相对较低 成本低，副作用少，但经常被忽视，在常规临床护理中很少出现。这 R34应用程序正在为随后的大型实用试验做准备，以检查明亮的有效性 光疗法（BLT）治疗抑郁症时，提供给现实世界的患者很少“脚手架”典型的高度 对照疗效试验。我们将进行一项可行性试验，选择90名患者作为样本， 单相抑郁或SAD的临床诊断，或PHQ-9评分>= 10，记录在健康计划的 电子健康记录（EHR）受试者将被随机分配至：第1组：作为药物治疗（TAU）：A “日常护理服务”对照组（例如，AD，心理治疗;允许所有TAU，并将记录所有 所有条件下的参与者）;组2：TAU +最小BLT鼓励：TAU+两个最小书面 通信（邮寄信件，安全的EHR消息）促进BLT作为一种有前途的治疗和概述 患者自行启动的步骤;第2组不包括任何电话指导或依从性促进;或第3组： TAU +增强BLT鼓励+坚持促进：TAU加上2-4个简短的电话，以鼓励BLT 使用灯箱（LB），就购买灯箱提供建议，协助获得保险报销，教育正确的 使用LB，并根据需要提供激励性访谈（MI）以促进依从性。主要结局是 PHQ-9自我报告的抑郁症状; BLT有效性的主要测试是两组之间的对比 2+3组与1组。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 其他次要结局，包括焦虑、残疾和情绪季节性，以及其他次要对比; 例如，在一个实施例中，2组vs 3组。我们还将研究适度效应;亚组中BLT效应的变化（例如， 接受与未接受TAU抗抑郁药的患者）;我们将研究BLT和MI的机制 通过候选介质的干预效果，包括正常化的昼夜节律，改善睡眠， 增加身体活动（BLT）和准备改变（MI）。该试点将产生可行性产品 协助成功进行随后的全面试验：招募成功估计数，参与者 保留和遵守BLT方案;完善遵守促进方案;以及估计 (with宽置信区间）的BLT有效性。