Clinical trial NCT06972303: Mindfulness Meditation for Insomnia
Official title: A Pilot Feasibility and Acceptability RCT of an App-Based Mindfulness Meditation Intervention for Sleep Among Patients With Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Sleep Initiation and Maintenance Disorders
Insomnia
Insomnia Chronic
Mindfulness
Telemedicine
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Screened-to-eligible ratio
timeFrame: Week 0
measure: Retention rate
timeFrame: Weeks 4, 8, and 16
measure: Adherence to intervention protocol
timeFrame: Week 4
measure: Compliance with outcome assessment
timeFrame: Weeks 0, 4, 8, 16
measure: Acceptability
timeFrame: Week 4
Secondary outcomes:
measure: Insomnia severity
timeFrame: Weeks 0, 4, 8, 16
measure: Sleep quality
timeFrame: Weeks 0, 4, 8, 16
Other outcomes:
Locations:
Study officials:
References: