NCT04160078: MINDS

Mindfulness IN-home for Diabetes and Sleep Health

Completed NA Results posted Last updated 28 September 2022

What this trial tests

NA trial testing Mindfulness-based stress reduction (MBSR) Intervention in Diabetes in 18 participants. Completed in 29 August 2021.

Timeline

18 December 2019

Primary endpoint
17 August 2021

29 August 2021

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	18
Start date	18 December 2019
Primary completion	17 August 2021
Estimated completion	29 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness-based stress reduction (MBSR) Intervention

Conditions studied

• Diabetes — all drugs for Diabetes →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Emory University

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pittsburgh Sleep Quality Index (PSQI) Score Primary · 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.

Baseline

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	7.22	± 2.96

4 weeks post-intervention

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	5.00	± 2.20

Sleep Duration Primary · Baseline, 4 weeks post-intervention

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.

Baseline assessed by actigraphy

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	6.19	± 1.05

4 weeks post-intervention assessed by actigraphy

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	6.18	± 1.45

Baseline assessed by self-report

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	8.30	± 1.33

4 weeks post-intervention assessed by self-report

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	8.15	± 1.82

Perceived Stress Scale (PSS) Primary · 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.

Baseline

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	15.72	± 7.73

4 weeks post-intervention

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	13.44	± 7.47

Number of Participants With PSS Score Indicating Low Stress Primary · 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.

Low stress at Baseline

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	7

Low stress at 4 weeks post-intervention

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	10

Number of Participants With PSS Score Indicating Moderate Stress Primary · 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.

Moderate stress at Baseline

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	10

Moderate stress at 4 weeks post-intervention

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	8

Number of Participants With PSS Score Indicating High Stress Primary · 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.

High stress at Baseline

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	1

High stress at 4 weeks post-intervention

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	0

Weight Secondary · Baseline, 4 weeks post-intervention

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

Baseline

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	180.64	± 30.00

4 weeks post-intervention

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	184.12	± 29.77

Body Mass Index (BMI) Secondary · Baseline, 4 weeks post-intervention

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.

Baseline

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	29.93	± 5.22

4 weeks post-assessment

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	30.21	± 5.27

Blood Pressure Secondary · 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.

Systolic blood pressure at Baseline

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	110.03	± 11.13

Systolic blood pressure at 4 weeks post-intervention

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	112.47	± 8.90

Diastolic blood pressure at Baseline

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	70.31	± 8.14

Diastolic blood pressure at 4 weeks post-intervention

Group	Value	95% CI
Mindfulness-based Stress Reduction (MBSR) Intervention	71.06	± 6.99

Adverse events — posted to ClinicalTrials.gov

Time frame: Information on adverse events was collected beginning at the time of participant consent through the follow up visit at 4 weeks post-intervention.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness-based Stress Reduction (MBSR) Intervention

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (1 terms — click to expand)

Reaction	System	Mindfulness-based Stress R…
Rash from sleep monitor wrist band	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04160078 adverse events section.

Sponsor's own description

The study investigates the effects of a mindfulness intervention on sleep and subsequent cardio-metabolic risk in an adult Atlanta population aged 18 and older.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.