Trial Outcomes & Findings for Mindfulness Training in Healthy Older Veterans (NCT NCT02816723)
NCT ID: NCT02816723
Last Updated: 2020-04-07
Results Overview
Participants' scores on the Geriatric Depression Scale were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. This outcome measure represents the change in score in Geriatric Depression Scale: pre-intervention score minus post-intervention score. The maximum Geriatric Depression Scale score is 30, and the minimum score is 0. Higher scores on the Geriatric Depression Scale indicate more depressive symptoms, so worse outcome. However, since we are analyzing a change in the Geriatric Depression Scale score of pre- minus post-intervention, a larger change score for a particular arm indicates a greater degree of improvement.
COMPLETED
NA
60 participants
Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)
2020-04-07
Participant Flow
Participant milestones
| Measure |
Mindfulness
Mindfulness-based Stress Reduction: mindfulness/meditation/movement training
|
Brain Health
Brain Health education class
Brain Health: Brain Health Education
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
24
|
28
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness Training in Healthy Older Veterans
Baseline characteristics by cohort
| Measure |
Mindfulness
n=24 Participants
Mindfulness-based Stress Reduction (MBSR): The MBSR group meets once per week for 2½ hours, with a day-long retreat in the 6th week of the 8-week program. Participants are instructed in mindfulness practice in the form of sitting meditation, body awareness, yoga, mindful movement, and informal mindfulness practices of daily life (e.g., eating, communicating, working, coping). The day-long retreat includes a review of class material, more lengthy meditation and yoga practice, as well as a group lunch. Between classes, patients enhance their participation by practicing at home with meditation CDs, homework assignments, and readings from the course materials and manual. Home practice is tracked with pre-made log sheets on which participants record the number of hours engaged in practice at home.
|
Brain Health
n=28 Participants
Brain Health education class:
The Brain Health class is matched for the same number of hours, instructor, schedule (including day-long retreat), homework, and home practice as that of the MBSR class. The class provides background and education about brain-behavior relationships and discusses how brain injuries can disrupt various aspects of cognition, such as memory and attention. There are also units on nutrition and sleep, including strategies for successful aging. To control for the yoga/movement portion of the MBSR class, the Brain Health class also includes simple chair exercises, such as stretching and reaching. The day-long retreat includes review of class topics, video documentaries on these topics, and a group lunch. The Brain Health class matches MBSR intervention for critical process elements such as clinician interaction, social interaction with the group, movement, schedule, and homework activities, without the inclusion of a meditative/mindfulness component.
|
Total
n=52 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
74.1 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
73.1 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Number of years of formal education, 0-20 years
|
16.2 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
16.9 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
16.6 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)Participants' scores on the Geriatric Depression Scale were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. This outcome measure represents the change in score in Geriatric Depression Scale: pre-intervention score minus post-intervention score. The maximum Geriatric Depression Scale score is 30, and the minimum score is 0. Higher scores on the Geriatric Depression Scale indicate more depressive symptoms, so worse outcome. However, since we are analyzing a change in the Geriatric Depression Scale score of pre- minus post-intervention, a larger change score for a particular arm indicates a greater degree of improvement.
Outcome measures
| Measure |
Mindfulness
n=24 Participants
Mindfulness-based Stress Reduction: mindfulness/meditation/movement training
|
Brain Health
n=28 Participants
Brain Health education class
Brain Health: Brain Health Education
|
|---|---|---|
|
Geriatric Depression Scale Change Score
|
.89 score on a scale
Standard Deviation 1.79
|
0.50 score on a scale
Standard Deviation .21
|
PRIMARY outcome
Timeframe: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)Participants' scores on the State-Trait Anxiety Inventory (STAI) were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. This outcome measure represents the change in score in State-Trait Anxiety Inventory: pre-intervention score minus post-intervention score. The maximum STAI score is 80, and the minimum score is 20. Higher scores on the STAI indicate more anxiety symptoms, so worse outcome. However, since we are analyzing a change in the STAI score of pre- minus post-intervention, a larger change score for a particular arm indicates a greater degree of improvement.
Outcome measures
| Measure |
Mindfulness
n=24 Participants
Mindfulness-based Stress Reduction: mindfulness/meditation/movement training
|
Brain Health
n=28 Participants
Brain Health education class
Brain Health: Brain Health Education
|
|---|---|---|
|
State-Trait Anxiety Inventory (STAI) Change Score
|
.06 units on a scale
Standard Deviation .22
|
2.75 units on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)Participants' scores on the Repeatable Battery for Neuropsychological Status (RBANS) were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. The maximum total scaled score is 160, and the minimum score is 40, where higher scores are better. This outcome measure represents the change in total scaled score on the RBANS: post-intervention score minus pre-intervention score. A higher change score for a particular arm indicates a greater degree of improvement.
Outcome measures
| Measure |
Mindfulness
n=24 Participants
Mindfulness-based Stress Reduction: mindfulness/meditation/movement training
|
Brain Health
n=28 Participants
Brain Health education class
Brain Health: Brain Health Education
|
|---|---|---|
|
Repeatable Battery for Neuropsychological Status (RBANS) Total Scaled Change Score
|
5.09 units on a scale
Standard Deviation 2.54
|
5.38 units on a scale
Standard Deviation 1.62
|
Adverse Events
Mindfulness
Brain Health
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Juliana Baldo
VA Northern California Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place