Mindfulness Meditation for Insomnia

Официальное название

A Pilot Feasibility and Acceptability RCT of an App-Based Mindfulness Meditation Intervention for Sleep Among Patients With Insomnia Disorder

Обзор

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.

Вмешательства

• Поведенческое Instructed bedtime app-guided mindfulness meditation
  All participants will access the a smartphone app, and the mindfulness meditation practice may involve techniques such as breathing exercise, imagery, body scan, and relaxation. The investigators will provide instructions for participants who are assigned to practice at bedtime.
• Поведенческое Uninstructed app-guided mindfulness meditation
  The guided mindfulness meditation practice will also be based on the same app. The investigators will not provide instructions for participants, and they have complete freedom to use the app as real-world users.
• Поведенческое Sleep hygiene education
  Sleep hygiene education will be based on recognized, general, non-personalized sleep hygiene advice, for example, recommendations about bedtime routines and use of alcohol and caffeine, tips on creating a sleep-conducive bedroom environment.

Первичные конечные точки

• Screened-to-eligible ratio [Срок оценки: Week 0]
• Retention rate [Срок оценки: Weeks 4, 8, and 16]
• Adherence to intervention protocol [Срок оценки: Week 4]
• Compliance with outcome assessment [Срок оценки: Weeks 0, 4, 8, 16]
• Acceptability [Срок оценки: Week 4]

Вторичные конечные точки (2)

• Insomnia severity [Срок оценки: Weeks 0, 4, 8, 16]
• Sleep quality [Срок оценки: Weeks 0, 4, 8, 16]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT06972303 · 2025P001314 · 1K23AT012475

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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