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物（AD）和心理疗法，例如 然而，这些治疗在理想情况下只能产生适度的效果。 当现实世界的患者以低利率开始治疗时，这些影响会进一步减弱。 依从性差或提前停药，这代表了支持抑郁症护理的差距。 开发和推广其他干预措施，其中一种替代疗法是强光疗法。 (BLT)，已确定对季节性情感障碍 (SAD) 和非 SAD 抑郁症的疗效，但相对较低 成本高，副作用少，但经常被忽视，并且很少出现在常规临床护理中。 R34 应用程序正在为随后的大型务实试验做准备，以检验光明的有效性 当现实世界的患者接受光疗法（BLT）治疗抑郁症时，几乎没有典型的高度“支架” 我们将开展一项可行性试验，选取 90 名接受新疗法的患者作为样本。 健康计划中记录的单相抑郁症或 SAD 的临床诊断，或 PHQ-9 评分 >= 10 电子健康记录 (EHR) 参与者将被随机分配至： 第 1 组：常规治疗 (TAU)：A “常规护理服务”对照组（例如 AD、心理治疗；所有 TAU 都是允许的，并将记录所有 第 2 组：TAU + 最低限度 BLT 鼓励：TAU 加上至少 2 份书面材料 宣传 BLT 作为一种有前途的治疗方法的通信（邮寄信件、安全 EHR 消息）并概述 患者自行启动的步骤；第 2 组将不包括任何电话辅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 次简短通话以鼓励 BLT 使用，建议购买灯箱（LB），协助获得保险报销，教育正确的 使用 LB，并根据需要提供动机访谈 (MI) 以促进依从性。 PHQ-9 自我报告的抑郁症状；BLT 有效性的主要测试是 Arms 之间的对比 2+3 与 Arm 1。我们将进行探索性分析，为未来的全功率试验做好准备。我们将进行检查。 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，第 2 组与第 3 组。我们还将检查亚组中 BLT 效应的变化（例如， 接受 TAU 抗抑郁药的患者与未接受 TAU 抗抑郁药的患者）；我们将研究 BLT 和 MI 的机制 通过候选调节剂的干预效果，包括正常化的昼夜节律、改善的睡眠和 增加体力活动（对于 BLT）和变革准备（对于 MI） 该试点将产生可行性产品。 协助成功进行后续全面试验：招募成功的估计、参与者 BLT 协议的保留和遵守；遵守促进协议的细化和估计； （具有宽置信区间）BLT 有效性。