Bramoweth Adam D, Hough Caroline E, McQuillan Amanda D, Spitznogle Brittany L, Thorpe Carolyn T, Lickel James J, Boudreaux-Kelly Monique, Hamm Megan E, Germain Anne
Mental Illness Research, Education and Clinical Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States.
Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States.
JMIR Res Protoc. 2023 Jul 20;12:e47636. doi: 10.2196/47636.
Chronic insomnia is one of the most common health problems among veterans and negatively impacts their health, function, and quality of life. Although cognitive behavioral therapy for insomnia (CBT-I) is the first-line recommended treatment, sedative-hypnotic medications remain the most common. Sedative-hypnotics, however, have mixed effectiveness, are frequently prescribed longer than recommended, and are associated with numerous risks and adverse effects that negatively impact veteran function. Meeting the treatment needs of veterans impacted by insomnia requires delivering gold standard behavioral care, like CBT-I, and the reduction of sedative-hypnotics through innovative methods.
The objective of this feasibility clinical trial is to test a digital CBT-I approach combined with deprescribing to improve the success of sedative-hypnotic reduction among veterans. The intervention combines Noctem Health Clinician Operated Assistive Sleep Technology (COAST), an effective and efficient, scalable, and adaptable digital platform to deliver CBT-I, with clinical pharmacy practitioner (CPP)-led deprescribing of sedative-hypnotic medications.
In this nonrandomized single-group clinical trial, 50 veterans will be recruited and enrolled to receive CBT-I delivered via Noctem COAST and CPP-led deprescribing for up to 12 weeks. Assessments will occur at baseline, posttreatment, and 3-month follow-up. The aims are to (1) assess the feasibility of recruiting veterans with chronic sedative-hypnotic use to participate in the combined intervention, (2) evaluate veterans' acceptability and usability of the COAST platform, and (3) measure changes in veterans' sleep, sedative-hypnotic use, and function at baseline, posttreatment, and 3-month follow-up.
The institutional review board approved the study in October 2021 and the trial was initiated in May 2022. Recruitment and data collection began in September 2022 and is anticipated to be completed in April 2024. Aim 1 will be measured by tracking the response to a mail-centric recruitment approach using electronic medical records to identify potentially eligible veterans based on sedative-hypnotic use. Aim 2 will be measured using the Post-Study System Usability Questionnaire, assessing overall usability as well as system usefulness, information quality, and interface quality. Aim 3 will use the Insomnia Severity Index and sleep diaries to measure change in insomnia outcomes, the Patient-Reported Outcome Measurement Information System Profile to measure change in physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, pain, cognitive function, and self-reported sedative-hypnotic use to measure change in dose and frequency of use.
Findings will inform the utility of a combined digital CBT-I and CPP-led deprescribing intervention and the development of an adequately powered clinical trial to test the effectiveness in a diverse sample of veterans. Further, findings will help inform potential new approaches to deliver care and improve access to care for veterans with insomnia, many of whom use sedative-hypnotics that may be ineffective and increase the risk for negative outcomes.
ClinicalTrials.gov NCT05027438; https://classic.clinicaltrials.gov/ct2/show/NCT05027438.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47636.
慢性失眠是退伍军人中最常见的健康问题之一，对他们的健康、功能和生活质量产生负面影响。尽管失眠的认知行为疗法（CBT-I）是一线推荐治疗方法，但镇静催眠药物仍是最常用的。然而，镇静催眠药的疗效参差不齐，处方时间经常超过推荐时长，且存在众多风险和不良反应，对退伍军人的功能产生负面影响。满足受失眠影响的退伍军人的治疗需求需要提供像CBT-I这样的金标准行为护理，并通过创新方法减少镇静催眠药的使用。
这项可行性临床试验的目的是测试一种数字CBT-I方法与减药方案相结合，以提高退伍军人减少镇静催眠药使用方面的成功率。该干预措施将Noctem Health临床医生操作的辅助睡眠技术（COAST）（一种有效、高效、可扩展且适应性强的用于提供CBT-I的数字平台）与临床药剂师主导的镇静催眠药减药方案相结合。
在这项非随机单组临床试验中，将招募50名退伍军人，让他们接受通过Noctem COAST提供的CBT-I以及临床药剂师主导的减药方案，为期最长12周。评估将在基线、治疗后和3个月随访时进行。目的是：（1）评估招募长期使用镇静催眠药的退伍军人参与联合干预措施的可行性；（2）评估退伍军人对COAST平台的可接受性和易用性；（3）测量退伍军人在基线、治疗后和3个月随访时睡眠、镇静催眠药使用情况和功能的变化。
机构审查委员会于2021年10月批准了该研究，试验于2022年5月启动。招募和数据收集于2022年9月开始，预计2024年4月完成。目标1将通过跟踪以邮件为中心的招募方法的响应情况来衡量，该方法使用电子病历根据镇静催眠药使用情况识别潜在符合条件的退伍军人。目标2将使用研究后系统可用性问卷进行衡量，评估总体可用性以及系统有用性、信息质量和界面质量。目标3将使用失眠严重程度指数和睡眠日记来衡量失眠结果的变化，使用患者报告结局测量信息系统概况来衡量身体功能、焦虑、抑郁、疲劳、睡眠障碍、参与社会角色、疼痛、认知功能的变化，并使用自我报告的镇静催眠药使用情况来衡量使用剂量和频率的变化。
研究结果将为数字CBT-I与临床药剂师主导的减药干预措施的效用提供信息，并为开展一项有足够效力的临床试验以测试在不同退伍军人样本中的有效性提供依据。此外，研究结果将有助于为提供护理的潜在新方法提供信息，并改善为失眠退伍军人提供护理的可及性，其中许多人使用的镇静催眠药可能无效且会增加负面结果的风险。
ClinicalTrials.gov NCT05027438；https://classic.clinicaltrials.gov/ct2/show/NCT05027438。
国际注册报告识别码（IRRID）：DERR1-10.2196/47636。
