Trial Outcomes & Findings for Mindfulness IN-home for Diabetes and Sleep Health (NCT NCT04160078)

NCT ID: NCT04160078

Last Updated: 2022-09-28

Results Overview

The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: Baseline, 4 weeks post-intervention
• Results posted on: 2022-09-28

Participant Flow

Participant milestones

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness IN-home for Diabetes and Sleep Health

Baseline characteristics by cohort

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Age, Continuous	29.89 years STANDARD_DEVIATION 10.16 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants
Education Less than Bachelor's degree	2 Participants n=5 Participants
Education Bachelor's degree	9 Participants n=5 Participants
Education Professional degree (Master's, MD, PhD, law degree)	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks post-intervention

Global sleep quality was measured via the validated Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated questionnaire which assesses several dimensions of sleep including sleep quality, duration, and disturbances over a 1-month time interval. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score which ranges from 0 to 21. Poor sleep quality is defined as a global score of 5 or greater.

Outcome measures

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Pittsburgh Sleep Quality Index (PSQI) Score Baseline	7.22 score on a scale Standard Deviation 2.96
Pittsburgh Sleep Quality Index (PSQI) Score 4 weeks post-intervention	5.00 score on a scale Standard Deviation 2.20

PRIMARY outcome

Timeframe: Baseline, 4 weeks post-intervention

Population: Some participants did not complete the 7-day actigraphy assessment.

Sleep duration was measured in hours and minutes using a sleep 7-day actigraphy (Philips Respironics Actiwatch Spectrum Plus) on the non-dominant wrist, and confirmed with daily sleep logs. Self-reported sleep duration was also measured.

Outcome measures

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Sleep Duration Baseline assessed by actigraphy	6.19 hours Standard Deviation 1.05
Sleep Duration 4 weeks post-intervention assessed by actigraphy	6.18 hours Standard Deviation 1.45
Sleep Duration Baseline assessed by self-report	8.30 hours Standard Deviation 1.33
Sleep Duration 4 weeks post-intervention assessed by self-report	8.15 hours Standard Deviation 1.82

PRIMARY outcome

Timeframe: Baseline, 4 weeks post-intervention

The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress.

Outcome measures

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Perceived Stress Scale (PSS) Baseline	15.72 score on a scale Standard Deviation 7.73
Perceived Stress Scale (PSS) 4 weeks post-intervention	13.44 score on a scale Standard Deviation 7.47

PRIMARY outcome

Timeframe: Baseline, 4 weeks post-intervention

The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress. Participants with scores of 0 to 13 are categorized as having low stress.

Outcome measures

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Number of Participants With PSS Score Indicating Low Stress Low stress at Baseline	7 Participants
Number of Participants With PSS Score Indicating Low Stress Low stress at 4 weeks post-intervention	10 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks post-intervention

The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress. Participants with scores of 14 to 26 are categorized as having moderate stress.

Outcome measures

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Number of Participants With PSS Score Indicating Moderate Stress Moderate stress at Baseline	10 Participants
Number of Participants With PSS Score Indicating Moderate Stress Moderate stress at 4 weeks post-intervention	8 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks post-intervention

The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress. Participants with scores of 27 to 40 are categorized as having high stress.

Outcome measures

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Number of Participants With PSS Score Indicating High Stress High stress at Baseline	1 Participants
Number of Participants With PSS Score Indicating High Stress High stress at 4 weeks post-intervention	0 Participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks post-intervention

Population: One participant did not report weight at the 4 week post-intervention assessment.

Participants provided their weight in pounds (lbs) based on a scale that was distributed to participants.

Outcome measures

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Weight Baseline	180.64 pounds Standard Deviation 30.00
Weight 4 weeks post-intervention	184.12 pounds Standard Deviation 29.77

SECONDARY outcome

Timeframe: Baseline, 4 weeks post-intervention

Population: One participant did not report weight at the 4 weeks post-intervention assessment.

Body mass index (BMI) is calculated as weight in kilograms (kg) divided by the square of the body height measured in meters (m). A BMI between 18.5 and 24.9 is considered to be normal weight. A BMI of 25-29.9 indicates overweight, while a BMI of 30 or more indicates obesity.

Outcome measures

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Body Mass Index (BMI) Baseline	29.93 kg/m^2 Standard Deviation 5.22
Body Mass Index (BMI) 4 weeks post-assessment	30.21 kg/m^2 Standard Deviation 5.27

SECONDARY outcome

Timeframe: Baseline, 4 weeks post-intervention

Blood pressure is the pressure of circulating blood on the walls of blood vessels and is measured in millimeters of mercury (mmHg). Three seated blood pressure measurements were made using an electronic sphygmomanometer. An average of the last two readings were used to assess systolic and diastolic blood pressure. Blood pressure values of less than 120 mmHg systolic and 80 mmHg diastolic are considered within the normal range.

Outcome measures

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 Participants Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Blood Pressure Systolic blood pressure at Baseline	110.03 mmHg Standard Deviation 11.13
Blood Pressure Systolic blood pressure at 4 weeks post-intervention	112.47 mmHg Standard Deviation 8.90
Blood Pressure Diastolic blood pressure at Baseline	70.31 mmHg Standard Deviation 8.14
Blood Pressure Diastolic blood pressure at 4 weeks post-intervention	71.06 mmHg Standard Deviation 6.99

Adverse Events

Mindfulness-based Stress Reduction (MBSR) Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mindfulness-based Stress Reduction (MBSR) Intervention n=18 participants at risk Participants receiving a stress reduction plus sleep education intervention to improve sleep health
Skin and subcutaneous tissue disorders Rash from sleep monitor wrist band	5.6% 1/18 • Information on adverse events was collected beginning at the time of participant consent through the follow up visit at 4 weeks post-intervention.

Additional Information

Dayna Johnson, PhD, MPH, MSW, MS

Emory University

Phone: 404-727-8708

Email: dayna.johnson@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place