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.

项目总结/摘要 拟议的行为和综合治疗发展方案（R34）的目标是 开发和测试一个基于证据的睡眠行为治疗的移动的健康（mHealth）应用 开始使用阿片类药物使用障碍（OUD）药物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是一线治疗方法， OUD，尽管接受MOUD的人的睡眠投诉非常普遍，持续存在，并与 消极的治疗结果。对接受MOUD治疗的患者的失眠和其他睡眠问题的干预 缺乏，因为药理学选择有限，接受循证医学治疗存在多种障碍。 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 提供者，以及面对面会议所涉及的时间和精力。改变基于证据的行为睡眠 通过以患者为中心的移动的应用程序进行干预，并特别考虑特定因素 接受MOUD的人将通过规避许多与以下有关的障碍来填补这一治疗空白： 获得面对面的治疗。拟议的研究将开发和测试一种行为睡眠药物- 基于移动的应用程序，其包括针对睡眠问题的干预组件， 在MOUD治疗中普遍存在，包括失眠，昼夜节律紊乱，噩梦和疼痛相关的 睡眠困难。本项目的最终目标是为大规模随机临床试验做准备。具体 目标包括：1）基于认知行为疗法开发移动健康应用程序NightRighter， 失眠，并增加了其他基于证据的睡眠干预措施，解决常见的睡眠相关 OUD/MOUD中的问题，使用来自开始MOUD（n=5）、稳定于MOUD（n=5）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， β测试（n=15-20）; 3）进行NightRighter与睡眠对照组相比的先导随机临床试验（RCT）。 卫生对照组（n=40），为更大规模的RCT做准备。本提案利用了 所有团队成员，包括测量OUD的睡眠问题，Wilkerson博士，OUD临床护理 Book和McCrae博士的临床研究经验，Dr. Ruggiero和莫兰博士的物质使用障碍的定性数据收集和分析。