Development of an mHealth Behavioral Sleep Medicine Intervention for use during Medication Assisted Treatment for Opioid Use Disorder

开发用于阿片类药物使用障碍药物辅助治疗的 mHealth 行为睡眠医学干预措施

• 批准号: 10681901
• 负责人: Allison Wilkerson
• 金额: $ 26.43万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10681901
• 关键词: Address; Adherence; Anxiety Disorders; Behavior Therapy; Behavioral; Books; Breathing; Circadian Rhythm Disorder; Circadian Rhythms; Clinical; Clinical Research; Cognitive; Cognitive Therapy; Control Groups; Data; Data Analyses; Data Collection; Development; Diagnostic; Dropout; Education; Evidence based intervention; Feedback; Goals; Individual; Integrative Therapy; Intervention; Interview; Literature; Manuals; Measures; Medicine; Mental Depression; Mobile Health Application; Mood Disorders; National Institute of Drug Abuse; Nature; Nightmare; Pain; Patients; Persons; Pharmacotherapy; Polysomnography; Population; Preparation; Program Development; Protocols documentation; Provider; Public Health; Quality of Care; Randomized; Randomized, Controlled Trials; Recovery; Relapse; Reporting; Research; Risk; Risk Factors; Running; Schedule; Sleep; Sleep Disorders; Sleeplessness; Structure; Substance Use Disorder; Suicide; Symptoms; Testing; Time; Training; Treatment outcome; Vulnerable Populations; Weight maintenance regimen; Work; abuse liability; acceptability and feasibility; clinical care; digital health; effective intervention; evidence base; experience; improved; instrument; intervention delivery; mHealth; medication for opioid use disorder; medication-assisted treatment; member; mobile application; opioid use disorder; pharmacologic; pilot test; poor sleep; premature; programs; randomized, clinical trials; recruit; skills; sleep difficulty; sleep health; smartphone application; substance use treatment; tool; usability

PROJECT SUMMARY/ABSTRACT The goal of the proposed Behavioral and Integrative Treatment Development Program (R34) is to develop and test a mobile health (mHealth) application of evidence-based behavioral treatment for sleep problems in persons beginning treatment for opioid use disorder (OUD) with medications for OUD (MOUD). OUD is a highly prevalent problem with major public health implications. MOUD is the first-line treatment for OUD, though sleep complaints in persons receiving MOUD are highly prevalent, persistent, and connected to negative treatment outcomes. Interventions for insomnia and other sleep problems in those receiving MOUD are lacking, as pharmacological options are limited and there are multiple barriers to receiving evidence-based non-pharmacological/cognitive behavioral treatment, including competing treatment demands, lack of trained providers, and time and effort involved in in-person sessions. Modifying evidence-based behavioral sleep interventions for delivery via a patient-focused mobile application with special consideration to factors specific to persons receiving MOUD would fill this treatment gap by circumventing many of these obstacles related to accessing in-person treatment. The proposed research will develop and test a behavioral sleep medicine- based mobile application that includes components of interventions for sleep problems that are highly prevalent in MOUD treatment, including insomnia, circadian rhythm disorders, nightmares, and pain-related sleep difficulty. The ultimate goal of this project is to prepare for a large scale randomized clinical trial. Specific aims include: 1) Develop a mHealth application, NightRighter, based on cognitive behavioral therapy for insomnia and augmented with other evidence-based sleep interventions that address common sleep-related problems in OUD/MOUD utilizing input from persons beginning MOUD (n=5), stabilized on MOUD (n=5) or providing treatment for those receiving MOUD (n=5); 2) Run usability tests of NightRighter through alpha and beta testing (n=15-20); 3) Conduct a pilot randomized clinical trial (RCT) of NightRighter compared to a sleep hygiene control group (n=40) in preparation for a larger RCT. This proposal leverages the skills and expertise of all team members, including measurement of sleep problems in OUD of Dr. Wilkerson, OUD clinical care and clinical research experience of Drs. Book and McCrae, implementation of digital health tools of Dr. Ruggiero, and qualitative data collection and analyses in substance use disorders of Dr. Moreland.

项目概要/摘要 拟议的行为和综合治疗发展计划 (R34) 的目标是 开发并测试基于证据的睡眠行为治疗的移动健康 (mHealth) 应用 开始使用 OUD 药物 (MOUD) 治疗阿片类药物使用障碍 (OUD) 的人存在的问题。 OUD 是一个非常普遍的问题，具有重大的公共卫生影响。 MOUD 是一线治疗 OUD，尽管接受 MOUD 的人的睡眠抱怨非常普遍、持续，并且与 负面的治疗结果。针对接受 MOUD 治疗的失眠和其他睡眠问题的干预措施 缺乏，因为药理学选择有限，并且接受基于证据的治疗存在多重障碍 非药物/认知行为治疗，包括竞争性治疗需求、缺乏训练有素的治疗 提供者，以及面对面会议所花费的时间和精力。改变基于证据的行为睡眠 通过以患者为中心的移动应用程序进行干预，并特别考虑具体因素 接受 MOUD 的人将通过规避许多与以下相关的障碍来填补这一治疗空白 获得面对面的治疗。拟议的研究将开发并测试一种行为睡眠药物—— 基于移动应用程序，其中包括高度睡眠问题的干预措施的组成部分 MOUD 治疗中普遍存在，包括失眠、昼夜节律紊乱、噩梦和疼痛相关 睡眠困难。该项目的最终目标是为大规模随机临床试验做准备。具体的 目标包括： 1) 开发基于认知行为疗法的 mHealth 应用程序 NightRighter 失眠，并通过其他基于证据的睡眠干预措施来解决常见的睡眠相关问题 OUD/MOUD 中的问题利用开始 MOUD (n=5)、稳定 MOUD (n=5) 的人员的输入或 为接受 MOUD 的患者提供治疗（n=5）； 2) 通过 alpha 运行 NightRighter 的可用性测试 Beta 测试（n=15-20）； 3) 对 NightRighter 与睡眠疗法进行对比进行试点随机临床试验 (RCT) 卫生对照组（n=40）为更大的随机对照试验做准备。该提案利用了技能和专业知识 所有团队成员的数据，包括 Wilkerson 博士的 OUD 睡眠问题测量、OUD 临床护理 以及博士的临床研究经验。 Book 和 McCrae，Dr. 数字健康工具的实施 Ruggiero，以及 Moreland 博士的物质使用障碍定性数据收集和分析。