Mindfulness Meditation for Insomnia
A Pilot Feasibility and Acceptability RCT of an App-Based Mindfulness Meditation Intervention for Sleep Among Patients With Insomnia Disorder
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2025
CompletedFirst Posted
Study publicly available on registry
May 15, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 29, 2028
February 25, 2026
February 1, 2026
2.5 years
April 29, 2025
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Screened-to-eligible ratio
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.
Week 0
Retention rate
Retention rate is defined as the percentage of participants who complete the entire follow-up period. Reasons for participant dropout will also be documented.
Weeks 4, 8, and 16
Adherence to intervention protocol
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.
Week 4
Compliance with outcome assessment
Compliance with outcome assessment will be determined by the percentage of participants who complete ≥ 70% of questionnaires at each time point.
Weeks 0, 4, 8, 16
Acceptability
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.
Week 4
Secondary Outcomes (2)
Insomnia severity
Weeks 0, 4, 8, 16
Sleep quality
Weeks 0, 4, 8, 16
Study Arms (3)
Instructed bedtime app-guided mindfulness meditation
EXPERIMENTALParticipants 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.
Uninstructed app-guided mindfulness meditation
EXPERIMENTALParticipants 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.
Sleep Hygiene Education only
OTHERParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
April 29, 2025
First Posted
May 15, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
December 29, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02