Trial Outcomes & Findings for A Personalized Mind-Body Intervention (MBI) for Improving Sleep Among Women Working in Healthcare (NCT NCT05789212)
NCT ID: NCT05789212
Last Updated: 2026-02-02
Results Overview
The effect of the personalized MBI intervention on individual's sleep duration will be assessed in each arm separately. Participants' daily sleep duration will be measured objectively using Fitbit devices and by self-reported questionnaires. Individual changes in the average daily sleep durations between the run-in and each treatment period will be reported using means and 95% CIs. Bland-Altman plots will be constructed to visualize agreement between Fitbit reported and self-reported sleep duration. The effects of treatment on sleep duration will be assessed using GEE with an unstructured variance-covariance matrix for measures on the same day to that night's sleep. This model accounts for possible autocorrelation and linear trends between sleep duration across time. A change between time points is reported (e.g., baseline (2 weeks) and 2 weeks for each intervention period (4 weeks per intervention)) as a value for each intervention period minus value at baseline.
COMPLETED
PHASE2
60 participants
Baseline (2 weeks) and 2 weeks for each intervention period (4 weeks total for each intervention)
2026-02-02
Participant Flow
Participant milestones
| Measure |
Personalized Trial Group 1 (ABCCBA)
Participants in Arm 1 will receive a Personalized Trial comprised of three components delivered in a ABCCBA sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.
Personalized Trial ABCCBA: Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (ABCCBA), where A-mindfulness, B-yoga, and C-guided walking.
|
Personalized Trial Group 2 (CBAABC)
Participants in Arm 2 will receive a Personalized Trial comprised of three components delivered in a CBAABC sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.
Personalized Trial CBAABC: Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (CBAABC), where A-mindfulness, B-yoga, and C-guided walking.
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|---|---|---|
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Overall Study
STARTED
|
30
|
30
|
|
Overall Study
First Intervention Block (2 Weeks)
|
30
|
30
|
|
Overall Study
Second Intervention Block (2 Weeks)
|
30
|
29
|
|
Overall Study
Third Intervention Block (2 Weeks)
|
30
|
29
|
|
Overall Study
Fourth Intervention Block (2 Weeks)
|
29
|
28
|
|
Overall Study
Fifth Intervention Block (2 Weeks)
|
29
|
28
|
|
Overall Study
Sixth Intervention Block (2 Weeks)
|
29
|
28
|
|
Overall Study
Follow-Up Block (2 Weeks)
|
29
|
28
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
1
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3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Personalized Mind-Body Intervention (MBI) for Improving Sleep Among Women Working in Healthcare
Baseline characteristics by cohort
| Measure |
Personalized Trial Group 1 (ABCCBA)
n=30 Participants
Participants in Arm 1 will receive a Personalized Trial comprised of three components delivered in a ABCCBA sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.
Personalized Trial ABCCBA: Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (ABCCBA), where A-mindfulness, B-yoga, and C-guided walking.
|
Personalized Trial Group 2 (CBAABC)
n=30 Participants
Participants in Arm 2 will receive a Personalized Trial comprised of three components delivered in a CBAABC sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.
Personalized Trial CBAABC: Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (CBAABC), where A-mindfulness, B-yoga, and C-guided walking.
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Total
n=60 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
48.53 years
STANDARD_DEVIATION 5.98 • n=13 Participants
|
49.20 years
STANDARD_DEVIATION 6.69 • n=15 Participants
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48.87 years
STANDARD_DEVIATION 6.30 • n=28 Participants
|
|
Sex/Gender, Customized
Female
|
30 Participants
n=13 Participants
|
30 Participants
n=15 Participants
|
60 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=13 Participants
|
5 Participants
n=15 Participants
|
9 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=13 Participants
|
25 Participants
n=15 Participants
|
51 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=13 Participants
|
3 Participants
n=15 Participants
|
7 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=13 Participants
|
4 Participants
n=15 Participants
|
10 Participants
n=28 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=13 Participants
|
19 Participants
n=15 Participants
|
33 Participants
n=28 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=13 Participants
|
4 Participants
n=15 Participants
|
9 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Baseline (2 weeks) and 2 weeks for each intervention period (4 weeks total for each intervention)The effect of the personalized MBI intervention on individual's sleep duration will be assessed in each arm separately. Participants' daily sleep duration will be measured objectively using Fitbit devices and by self-reported questionnaires. Individual changes in the average daily sleep durations between the run-in and each treatment period will be reported using means and 95% CIs. Bland-Altman plots will be constructed to visualize agreement between Fitbit reported and self-reported sleep duration. The effects of treatment on sleep duration will be assessed using GEE with an unstructured variance-covariance matrix for measures on the same day to that night's sleep. This model accounts for possible autocorrelation and linear trends between sleep duration across time. A change between time points is reported (e.g., baseline (2 weeks) and 2 weeks for each intervention period (4 weeks per intervention)) as a value for each intervention period minus value at baseline.
Outcome measures
| Measure |
Personalized Trial Group 1 (ABCCBA)
n=30 Participants
Participants in Arm 1 will receive a Personalized Trial comprised of three components delivered in a ABCCBA sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.
Personalized Trial ABCCBA: Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (ABCCBA), where A-mindfulness, B-yoga, and C-guided walking.
|
Personalized Trial Group 2 (CBAABC)
n=30 Participants
Participants in Arm 2 will receive a Personalized Trial comprised of three components delivered in a CBAABC sequence over a total period of 12 weeks, where A-mindfulness, B-yoga, and C-guided walking. Participants in this arm will be prompted to complete 3 x 30-minute intervention sessions weekly during applicable treatment weeks. Interventions will be delivered by a virtual link to online videos recorded by an experienced wellness provider. Participants will be limited to three views of the study-provided intervention content each week.
Personalized Trial CBAABC: Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (CBAABC), where A-mindfulness, B-yoga, and C-guided walking.
|
Overall (All Participants)
n=60 Participants
Participants in Arm 1 and Arm 2
|
|---|---|---|---|
|
Mean Within-Subject Difference in Daily Sleep Duration
Guided Walking (C)
|
0.10 minutes per day
Interval -12.6 to 12.8
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3.45 minutes per day
Interval -12.0 to 18.9
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1.74 minutes per day
Interval -7.04 to 10.5
|
|
Mean Within-Subject Difference in Daily Sleep Duration
Mindfulness Meditation (A)
|
0.43 minutes per day
Interval -11.9 to 12.8
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1.66 minutes per day
Interval -14.1 to 17.4
|
0.81 minutes per day
Interval -7.94 to 9.57
|
|
Mean Within-Subject Difference in Daily Sleep Duration
Yoga (B)
|
-2.89 minutes per day
Interval -15.2 to 9.41
|
5.94 minutes per day
Interval -9.78 to 21.7
|
1.27 minutes per day
Interval -7.43 to 9.97
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OTHER_PRE_SPECIFIED outcome
Timeframe: 13-16 weeksSleep latency is an important parameter in a sleep study. The duration of time between when the lights are turned off (lights out) as the patient attempts to sleep, until the time patient actually falls asleep will be reported as sleep latency and aggregated daily using Fitbit devices. The effect of the personalized MBI intervention on individual's sleep latency will be assessed in each arm separately. Individual changes in the average daily sleep latency between the run-in and each treatment period will be reported using means (95% CIs) and modeled using Generalized estimating equations (GEE).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 13-16 weeksSleep efficiency (SE) is an indicator of sleep quality. SE is commonly defined as the ratio of total sleep time (TST) to time in bed (TIB). Values (as percentages) greater than or equal to 85% indicate good sleep quality (Ohayon et al., 2017 \[PMID: 28346153\]). SE will be recorded and aggregated daily using Fitbit devices. The effect of the personalized MBI intervention on individual's SE be assessed in each arm separately. Individual changes in the average daily sleep efficiency between the run-in and each treatment period will be reported using means (95% CIs) and modeled using Generalized estimating equations (GEE).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 13-16 weeksFitbit calculates the resting heart rate by measuring the heart rate when it detects sleep, and by measuring it throughout the day while an individual is but inactive (no steps detected). Resting heart rate will be recorded and aggregated daily using Fitbit devices. The effect of the personalized MBI intervention on individual's resting heart rate will be assessed in each arm separately. Individual changes in the average resting heart rate between the run-in and each treatment period will be reported using means (95% CIs) and modeled using Generalized estimating equations (GEE).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 13-16 weeksThe number of steps per day (physical activity) will be recorded and aggregated daily using Fitbit devices. The effect of the personalized MBI intervention on individual's number of steps per day will be assessed in each arm separately. Individual changes in the daily average number of steps between the run-in and each treatment period will be reported using means (95% CIs) and modeled using Generalized estimating equations (GEE).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 13-16 weeksParticipant's perceived stress score will be measured using the Perceived Stress Scale (PSS) (scale 0 to 40) and the Ecological Momentary Assessment (EMA) Stress questionnaire (scale 0 to 10). PSS and EMA will be evaluated pre-intervention (run-in), bi-weekly during the intervention, and post-intervention. Individual changes in the average PSS and EMA scores between the run-in and each treatment period will be reported using means (95% CIs).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 13-16 weeksParticipant's anxiety and depressive disorder scores will be assessed using the Patient Health Questionnaire (PHQ-4), a self-report version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) on a scale of 0 to 3 for a total of four items. Total score will be determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. PHQ-4 will be evaluated pre-intervention (run-in), bi-weekly during the intervention, and post-intervention. Individual changes in the average PHQ-4 scores between the run-in and each treatment period will be reported using means (95% CIs). The role of anxiety and depression as a potential mediator (M) between perceived stress (X) and sleep score (Y), will be determined by mixed effects regression models.
Outcome measures
Outcome data not reported
Adverse Events
Mindfulness Meditation (A)
Yoga (B)
Walking (C)
No Intervention (Baseline)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mindfulness Meditation (A)
n=60 participants at risk
Mindfulness meditation (Intervention A) was delivered to participants in the Personalized Trials arms as part of their ABCCBA and CBAABC intervention sequences. Participants were asked to complete virtual mindfulness meditation sessions via link to an online video 3 times per week in 2-week blocks.
|
Yoga (B)
n=60 participants at risk
Yoga (Intervention B) was delivered to participants in the Personalized Trials arms as part of their ABCCBA and CBAABC intervention sequences. Participants were asked to complete virtual yoga sessions via link to an online video 3 times per week in 2-week blocks.
|
Walking (C)
n=60 participants at risk
Walking (Intervention C) was delivered to participants in the Personalized Trials arms as part of their ABCCBA and CBAABC intervention sequences. Participants were asked to complete virtual walking sessions via link to an online video 3 times per week in 2-week blocks.
|
No Intervention (Baseline)
n=60 participants at risk
The 2-week baseline period at the start of the trial to determine eligibility for the intervention period. No interventions delivered during baseline.
|
|---|---|---|---|---|
|
General disorders
Skin irritation from Fitbit device
|
5.0%
3/60 • Number of events 3 • Non-systematic adverse event data was collected over the course of the 16-week trial: 2-week baseline period, 12-week intervention, and 2-week follow-up period.
|
0.00%
0/60 • Non-systematic adverse event data was collected over the course of the 16-week trial: 2-week baseline period, 12-week intervention, and 2-week follow-up period.
|
3.3%
2/60 • Number of events 2 • Non-systematic adverse event data was collected over the course of the 16-week trial: 2-week baseline period, 12-week intervention, and 2-week follow-up period.
|
1.7%
1/60 • Number of events 1 • Non-systematic adverse event data was collected over the course of the 16-week trial: 2-week baseline period, 12-week intervention, and 2-week follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place