Health TrialsbyHealthPanel

Mindfulness Meditation for Insomnia

ConditionsSleep Initiation and Maintenance DisordersInsomniaInsomnia ChronicMindfulnessTelemedicine
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Instructed bedtime app-guided mindfulness meditationExperimental treatment 2 interventions
Group B: Uninstructed app-guided mindfulness meditationExperimental treatment 2 interventions
Group C: Sleep Hygiene Education onlyOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 0
2

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.

Time frame
Weeks 4, 8, and 16
3

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.

Time frame
Week 4
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.

Time frame
Weeks 0, 4, 8, 16

Secondary outcomes

1

Insomnia severity

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.

Time frame
Weeks 0, 4, 8, 16
2

Sleep quality

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.

Time frame
Weeks 0, 4, 8, 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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