A Pilot Feasibility and Acceptability RCT of an App-Based Mindfulness Meditation Intervention for Sleep Among Patients With Insomnia Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Compliance with outcome assessment
研究概览
简要总结
The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability of the intervention and study procedures. Aim 2 is to explore patterns of within-group changes in sleep outcomes (i.e., insomnia severity and sleep quality). Patient-reported outcomes will be collected using a HIPAA-compliant electronic data management system (REDCap). Following informed consent, participants will receive links to REDCap surveys via email at Weeks 0, 4, 8, and 16. The investigators will also conduct a post-intervention interview at the end of Week 4 and an exit interview at Week 16. All participants will also receive a research kit with wearable devices and meet with our staff after they receive the kit for instructions. Data collected in the pilot RCT will help us to preliminarily identify tools for subjective measures and physiological signals to inform a future trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older;
- •Chronic insomnia (≥ 3 nights/week, for ≥ 3 months), defined by DSM-V or ICSD-3;
- •Have a primary complaint of difficulty falling asleep (sleep-onset insomnia) with self-reported sleep onset latency >20 min;
- •Insomnia Severity Index score ≥ 15;
- •Speak and understand English;
- •Have a smart device (phone or tablet) for mobile app installation
排除标准
- •Current diagnosis of sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, REM sleep behavior disorder, etc.);
- •Shift worker or routine night shifts;
- •Women with pregnancy or breastfeeding;
- •Regular (defined as twice a week or more) practice of mind-body interventions;
- •Patients with pace-maker or routinely using cardiovascular medications that have effects on heart rates (i.e., beta-blockers);
- •Neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.) or current diagnosis of comorbid psychotic, substance use, and trauma-related disorders;
- •Currently under medications with sleep changing effects (e.g., anxiolytics/benzodiazepines, selective serotonin reuptake inhibitors, hypnotics, etc.);
- •Hearing impairment or loss. Participants will be asked to report any medication for at least 2 weeks prior to study onset and during the study period.
研究组 & 干预措施
Sleep Hygiene Education only
Participants will receive sleep hygiene education and asked not to start any new insomnia treatments. Sleep hygiene education serves as a minimal intervention control condition and real-world comparator. At the end of the study, interested participants in the control group will be given equal access to the mobile app. Usual care for insomnia typically involves sleep hygiene education, so all three groups will receive standard SHE as part of usual care.
干预措施: Sleep hygiene education (Behavioral)
Instructed bedtime app-guided mindfulness meditation
Participants will utilize the specific sleep program available within the app, which will include a choice of audio soundtracks for guided MM (no exposure to screen lights during practice). The practice may involve techniques such as breathing exercise, imagery, body scan, and relaxation. Participants will specifically use the app during the immediate pre-sleep period. They can choose their preferred meditation sessions within the Sleep menu in Week 1-4.
干预措施: Instructed bedtime app-guided mindfulness meditation (Behavioral)
Instructed bedtime app-guided mindfulness meditation
Participants will utilize the specific sleep program available within the app, which will include a choice of audio soundtracks for guided MM (no exposure to screen lights during practice). The practice may involve techniques such as breathing exercise, imagery, body scan, and relaxation. Participants will specifically use the app during the immediate pre-sleep period. They can choose their preferred meditation sessions within the Sleep menu in Week 1-4.
干预措施: Sleep hygiene education (Behavioral)
Uninstructed app-guided mindfulness meditation
Participants will be asked to practice MM using the same app during daytime (prior to the evening meal), but without specific study instructions around components to access or specific time of practice.
干预措施: Uninstructed app-guided mindfulness meditation (Behavioral)
Uninstructed app-guided mindfulness meditation
Participants will be asked to practice MM using the same app during daytime (prior to the evening meal), but without specific study instructions around components to access or specific time of practice.
干预措施: Sleep hygiene education (Behavioral)
结局指标
主要结局
Compliance with outcome assessment
时间窗: Weeks 0, 4, 8, 16
Compliance with outcome assessment will be determined by the percentage of participants who complete ≥ 70% of questionnaires at each time point.
Screened-to-eligible ratio
时间窗: Week 0
The proportion of screened participants who were determined to be eligible for the study; calculated as the number of eligible participants divided by the total number of individuals screened.
Retention rate
时间窗: Weeks 4, 8, and 16
Retention rate is defined as the percentage of participants who complete the entire follow-up period. Reasons for participant dropout will also be documented.
Adherence to intervention protocol
时间窗: Week 4
In the intervention groups, a mindfulness meditation session ≥ 10 minutes will be considered as a completed session. Numbers of sessions completed during the four weeks will be recorded. Adherence to intervention protocol will be defined as those randomized to the intervention groups complete ≥ 70% of home practice.
Acceptability
时间窗: Week 4
At intervention end (week 4), a brief questionnaire will ask participants to rate (1=not at all to 5=very much) the enjoyableness, convenience, helpfulness, and overall satisfaction with the app-based mindfulness practice. Acceptability is assessed by self-report survey ratings, and a threshold of 80% ratings of 4 or higher will indicate acceptability.
次要结局
- Insomnia severity(Weeks 0, 4, 8, 16)
- Sleep quality(Weeks 0, 4, 8, 16)
研究者
Yan Ma, MD, MPH
Instructor
Brigham and Women's Hospital