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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM103499-20 | U.S. NIH Grant/Contract | View source | |
| P217A180094 | Other Grant/Funding Number | Winthrop McNair Scholars Program |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This study will examine short breathing meditations paired with Fitbit technology in order to assess mindfulness and track physical activity. Measures including heart rate, physical activity, sleep patterns, as well as assessments of well-being and anxiety levels, will be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Uses Fitbit, does not participate in breathing meditation. | |
| Meditation | Experimental | Uses Fitbit and participates in brief, daily breathing meditation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing meditation | Behavioral | Daily, 5-minute breathing meditation for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mindfulness | 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. | Baseline and 2 weeks post-baseline |
| Change in Anxiety | 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.) | Baseline and 2 weeks post-baseline |
| Change in Well-being | 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. | Baseline and 2 weeks post-baseline |
| Change in Worry | 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. | Baseline and 2 weeks post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Minutes | Duration of sleep in minutes as measured using Fitbit. An increase in duration of sleep indicated improvement. | Baseline and 2 weeks |
| Change in Heart Rate | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney Guenther | Winthrop University - Rock Hill, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University | Rock Hill | South Carolina | 29733 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Uses Fitbit, does not participate in breathing meditation. |
| FG001 | Meditation | Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Uses Fitbit, does not participate in breathing meditation. |
| BG001 | Meditation | Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mindfulness | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 weeks post-baseline |
|
Through study completion, an average of 2 weeks
34
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Uses Fitbit, does not participate in breathing meditation. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Compliance Coordinator | Winthrop University | 8033232460 | smithmr@winthrop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2021 | Jan 5, 2024 | Prot_SAP_000.pdf |
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| Change in Depression | 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.) | Baseline and 2 weeks post-baseline |
| Baseline and 2 weeks |
| Change in Steps | 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) | Baseline and 2 weeks |
| Change in Physically Active Minutes | Amount of time spent being physically active in minutes as reported by Fitbit. An increase in time spent being physically active indicated improvement. | Baseline and 2 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week. |
|
|
| Primary | Change in Anxiety | 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.) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 weeks post-baseline |
|
|
|
| Primary | Change in Well-being | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 weeks post-baseline |
|
|
|
| Primary | Change in Worry | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 weeks post-baseline |
|
|
|
| Primary | Change in Depression | 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.) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2 weeks post-baseline |
|
|
|
| Secondary | Change in Sleep Minutes | Duration of sleep in minutes as measured using Fitbit. An increase in duration of sleep indicated improvement. | Posted | Mean | Standard Deviation | Duration of sleep in minutes | Baseline and 2 weeks |
|
|
|
| Secondary | Change in Heart Rate | 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) | Posted | Mean | Standard Deviation | Beats per minute of heart | Baseline and 2 weeks |
|
|
|
| Secondary | Change in Steps | 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) | Posted | Mean | Standard Deviation | number of steps taken | Baseline and 2 weeks |
|
|
|
| Secondary | Change in Physically Active Minutes | Amount of time spent being physically active in minutes as reported by Fitbit. An increase in time spent being physically active indicated improvement. | Posted | Mean | Standard Deviation | Duration of physical activity minutes | Baseline and 2 weeks |
|
|
|
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Meditation | Uses Fitbit and participates in brief, daily breathing meditation. Breathing meditation: Daily, 5-minute breathing meditation for one week. | 0 | 17 | 0 | 17 | 0 | 17 |
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