Trial Outcomes & Findings for Video Based Mindfulness Based Stress Reduction (NCT NCT02705586)
NCT ID: NCT02705586
Last Updated: 2019-10-31
Results Overview
Enzyme-linked immunoassay salivary cortisol levels (ng/mL) taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2019-10-31
Participant Flow
From March 2016 to May 2016, 8 Parkinson's disease veterans and their caregivers were recruited for the 10-week Mindfulness-Based Stress Reduction classes held at the VA Portland Health Care System in Portland, Oregon.
13 participants consented for the study. 4 withdrew after screening prior to the intervention due to the amount of travel to the Portland VA in the study.
Participant milestones
| Measure |
Only One Arm - Open Label Study
Mindfulness: Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
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|---|---|
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Overall Study
STARTED
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13
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|
Overall Study
COMPLETED
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5
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Only One Arm - Open Label Study
Mindfulness: Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
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|---|---|
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Overall Study
Health Issues
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2
|
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Overall Study
Transportation Difficulties
|
5
|
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Overall Study
Vacation/Planned Absence
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1
|
Baseline Characteristics
8/13 participants had Parkinson's disease. This questionnaire is only appropriate for Parkinson's disease participants.
Baseline characteristics by cohort
| Measure |
Only One Arm - Open Label Study
n=13 Participants
Mindfulness: Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
|
|---|---|
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Age, Continuous
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71.7 years
STANDARD_DEVIATION 6.8 • n=13 Participants
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|
Sex: Female, Male
Female
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6 Participants
n=13 Participants
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Sex: Female, Male
Male
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7 Participants
n=13 Participants
|
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Region of Enrollment
United States
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13 Participants
n=13 Participants
|
|
Years of Formal Education
|
14.9 years
STANDARD_DEVIATION 2.5 • n=13 Participants
|
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Montreal Cognitive Assessment (MoCA)
|
25.4 units on a scale
STANDARD_DEVIATION 2.2 • n=13 Participants
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United Parkinsons Disease Rating Scale - Part III motor section (UPDRS)
|
26.6 units on a scale
STANDARD_DEVIATION 8.5 • n=8 Participants • 8/13 participants had Parkinson's disease. This questionnaire is only appropriate for Parkinson's disease participants.
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Hoehn & Yahr
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2.2 units on a scale
STANDARD_DEVIATION 0.3 • n=8 Participants • 8/13 participants had Parkinson's disease. This questionnaire is only appropriate for Parkinson's disease participants.
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Perceived Stress Scale (PSS)
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12.7 units on a scale
STANDARD_DEVIATION 7.5 • n=13 Participants
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Hamilton Anxiety Rating Scale (HAM - A)
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10.8 units on a scale
STANDARD_DEVIATION 7.6 • n=13 Participants
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Hamilton Depression Rating Scale (HAM - D)
|
7.2 units on a scale
STANDARD_DEVIATION 6.7 • n=13 Participants
|
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Parkinson's Disease Questionnaire 39 (PDQ-39)
|
37.4 units on a scale
n=8 Participants • 8 of the 13 participants had Parkinson's disease. This questionnaire is only appropriate for Parkinson's disease participants.
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Parkinson Disease Questionnaire - Carer (PDQ-Carer)
|
13 units on a scale
n=4 Participants • 5/13 participants were caregivers of Parkinson's disease patients. This questionnaire is only appropriate for caregivers of Parkinson's disease participants. One participant did not complete the questionnaire because they were not in a caregiver role for the Parkinson's disease participant.
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PRIMARY outcome
Timeframe: Baseline to 12 weeksEnzyme-linked immunoassay salivary cortisol levels (ng/mL) taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention.
Outcome measures
| Measure |
Only One Arm - Open Label Study
n=5 Participants
Mindfulness: Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
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|---|---|
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Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program
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-33.1 Concentration (ng/mL)
Standard Deviation 41.5
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Adverse Events
Only One Arm - Open Label Study
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place