Trial Outcomes & Findings for Use of Fitbits During Breathing Meditation (NCT NCT05101343)

NCT ID: NCT05101343

Last Updated: 2024-07-08

Results Overview

Mindful Attention Awareness Scale (MAAS.) The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness,namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. The survey consists of 15 questions using a Likert scale. Responses range from 1 (Almost Always) to 6 (Almost Never.)The scale is scored by computing a mean of the 15 items on the questionnaire. Score ranges of 15 (low) to 90 (high.) A higher score indicates a higher level of dispositional mindfulness.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: Baseline and 2 weeks post-baseline
• Results posted on: 2024-07-08

Participant Flow

Participant milestones

Measure	Control Uses Fitbit, does not participate in breathing meditation.	Meditation Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Overall Study STARTED	19	18
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Control Uses Fitbit, does not participate in breathing meditation.	Meditation Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Use of Fitbits During Breathing Meditation

Baseline characteristics by cohort

Measure	Control n=17 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=17 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34 years STANDARD_DEVIATION 14 • n=5 Participants	31 years STANDARD_DEVIATION 13 • n=7 Participants	34 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino/Spanish	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Multi-racial	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Prefer not to answer	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 weeks post-baseline

Mindful Attention Awareness Scale (MAAS.) The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness,namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. The survey consists of 15 questions using a Likert scale. Responses range from 1 (Almost Always) to 6 (Almost Never.)The scale is scored by computing a mean of the 15 items on the questionnaire. Score ranges of 15 (low) to 90 (high.) A higher score indicates a higher level of dispositional mindfulness.

Outcome measures

Measure	Control n=17 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=17 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Change in Mindfulness	-0.08 score on a scale Standard Deviation 0.57	0.1 score on a scale Standard Deviation 0.43

PRIMARY outcome

Timeframe: Baseline and 2 weeks post-baseline

Hospital Anxiety and Depression Scale (HADS). This questionnaire is used to measure anxiety and depression. Scale ranges are from 0 to 3. Lower values represent a better outcome. Total scores for depression and anxiety are summed. A score of 0-7 = normal. A score of 8-10 = borderline abnormal (borderline case.) A score of 11-21 = abnormal (case.)

Outcome measures

Measure	Control n=17 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=17 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Change in Anxiety	-.18 score on a scale Standard Deviation 2.27	-2.35 score on a scale Standard Deviation 3.64

PRIMARY outcome

Timeframe: Baseline and 2 weeks post-baseline

Mental Health Continuum Short Form (MHC-SF.) This questionnaire measures emotional, psychological, and social well-being. It consists of 14 questions scored on a Likert scale ranging from 0-5. Items 1-3 indicate emotional well-being (range 0-15). Items 4-8 indicate social well-being (0-25). Items 9-14 indicate psychological well-being (0-30). Total well-being score as reported here was calculated by adding the three sub-scores together (range 0-70). Higher scores indicate higher well-being for subscales and total well-being.

Outcome measures

Measure	Control n=17 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=16 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Change in Well-being	3.00 score on a scale Standard Deviation 8.89	3.75 score on a scale Standard Deviation 10.33

PRIMARY outcome

Timeframe: Baseline and 2 weeks post-baseline

UMC (University Medical Centre) Penn State Worry Questionnaire. This is a 16 item questionnaire. Scale ranges from 0 (Not Typical at All) to 4 (Very Typical.) A higher score indicates a higher propensity for worry.

Outcome measures

Measure	Control n=15 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=17 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Change in Worry	-0.13 score on a scale Standard Deviation 7.03	-1.59 score on a scale Standard Deviation 6.05

PRIMARY outcome

Timeframe: Baseline and 2 weeks post-baseline

Hospital Anxiety and Depression Scale (HADS). This questionnaire is used to measure anxiety and depression. Scale ranges are from 0 to 3. Lower values represent a better outcome. Total scores for depression and anxiety are summed. A score of 0-7 = normal. A score of 8-10 = borderline abnormal (borderline case.) A score of 11-21 = abnormal (case.)

Outcome measures

Measure	Control n=17 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=17 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Change in Depression	-1.12 units on a scale Standard Deviation 2.57	-0.53 units on a scale Standard Deviation 2.90

SECONDARY outcome

Timeframe: Baseline and 2 weeks

Duration of sleep in minutes as measured using Fitbit. An increase in duration of sleep indicated improvement.

Outcome measures

Measure	Control n=14 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=13 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Change in Sleep Minutes	-10.76 Duration of sleep in minutes Standard Deviation 36.47	6.33 Duration of sleep in minutes Standard Deviation 21.43

SECONDARY outcome

Timeframe: Baseline and 2 weeks

Changes in heart rate in beats per minute as measured by Fitbit (average observed heart rate during Week 2 minus the average heart rate observed during Week 1)

Outcome measures

Measure	Control n=16 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=14 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Change in Heart Rate	-0.49 Beats per minute of heart Standard Deviation 1.75	-0.12 Beats per minute of heart Standard Deviation 2.84

SECONDARY outcome

Timeframe: Baseline and 2 weeks

Change in number of steps taken as measured by Fitbit (average number of steps taken during Week 2 minus the average number of steps taken during Week 1)

Outcome measures

Measure	Control n=17 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=15 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Change in Steps	-56.12 number of steps taken Standard Deviation 1186.91	271.96 number of steps taken Standard Deviation 1678.45

SECONDARY outcome

Timeframe: Baseline and 2 weeks

Amount of time spent being physically active in minutes as reported by Fitbit. An increase in time spent being physically active indicated improvement.

Outcome measures

Measure	Control n=17 Participants Uses Fitbit, does not participate in breathing meditation.	Meditation n=15 Participants Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week.
Change in Physically Active Minutes	-7.45 Duration of physical activity minutes Standard Deviation 33.45	3.02 Duration of physical activity minutes Standard Deviation 49.7

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Meditation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Compliance Coordinator

Winthrop University

Phone: 8033232460

Email: smithmr@winthrop.edu

Results disclosure agreements

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