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NCT Number: NCT06972303

Mindfulness Meditation for Insomnia

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.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Insomnia Insomnia Chronic Mental Disorders Mindfulness Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders Telemedicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Yan Ma

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Instructed bedtime app-guided mindfulness meditation

Behavioral

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.

Other names: Uninstructed bedtime app-guided mindfulness meditation, Sleep hygiene education

Uninstructed app-guided mindfulness meditation

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Screened-to-eligible ratio

    Time frame: 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.

  2. Retention rate

    Time frame: 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.

  3. Adherence to intervention protocol

    Time frame: 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.

  4. Compliance with outcome assessment

    Time frame: 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.

  5. Acceptability

    Time frame: 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.

Secondary outcomes

  1. Insomnia severity

    Time frame: Weeks 0, 4, 8, 16

    Insomnia severity will be assessed by the Insomnia Severity Index (ISI), a brief instrument that assesses insomnia. Its reliability, validity, and sensitivity to treatment response have been documented in the general population and with patients with insomnia. The total score ranges from 0 to 28, and higher scores indicate more severe insomnia. This secondary/exploratory outcome will be summarized with simple descriptive statistics without formal efficacy testing.

  2. Sleep quality

    Time frame: Weeks 0, 4, 8, 16

    Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). PSQI is a subjective sleep assessment, which includes multiple sleep-related variables over the preceding month. The PSQI yields seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The global score ranges from 0 to 21, and higher scores suggest greater sleep disturbance. This secondary/exploratory outcome will be summarized with simple descriptive statistics without formal efficacy testing.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Ma

CONTACT

[email protected]

(617) 732-8544

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 15, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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