Trial Outcomes & Findings for A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults (NCT NCT02714426)
NCT ID: NCT02714426
Last Updated: 2019-03-07
Results Overview
The Attention Network Task is a computerized test that measures three different components of attention (alerting, orienting, and conflict monitoring). Score is the computed as the difference between reaction time on correct trials in cued and uncued conditions. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Results posted on
2019-03-07
Participant Flow
Participant milestones
| Measure |
Brain Health
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
Participants in both interventions receive all study measures equivalently at all occasions
|
Mindfulness-inspired Treatment/Testing
Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.
Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Brain Health
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
Participants in both interventions receive all study measures equivalently at all occasions
|
Mindfulness-inspired Treatment/Testing
Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.
Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
A 14 Week Study of Mindfulness Effects on Attentional Control in Older Adults
Baseline characteristics by cohort
| Measure |
Brain Health
n=21 Participants
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
Participants in both interventions receive all study measures equivalently at all occasions
|
Mindfulness-inspired Treatment/Testing
n=21 Participants
Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.
Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness treatment.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.75 years
STANDARD_DEVIATION 4.83 • n=5 Participants
|
74.95 years
STANDARD_DEVIATION 6.18 • n=7 Participants
|
73.85 years
STANDARD_DEVIATION 15.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
The Attention Network Task is a computerized test that measures three different components of attention (alerting, orienting, and conflict monitoring). Score is the computed as the difference between reaction time on correct trials in cued and uncued conditions. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
Outcome measures
| Measure |
Brain Health
n=20 Participants
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
Participants in both interventions receive all study measures equivalently at all occasions
|
Mindfulness-inspired Treatment/Testing
n=20 Participants
Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.
Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment
|
|---|---|---|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week13
|
45.0 units on a scale
Standard Deviation 9.4
|
50.4 units on a scale
Standard Deviation 8.8
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week1
|
51.6 units on a scale
Standard Deviation 14.4
|
60.4 units on a scale
Standard Deviation 8.0
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week2
|
51.2 units on a scale
Standard Deviation 11.7
|
57.3 units on a scale
Standard Deviation 10.9
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week3
|
50.4 units on a scale
Standard Deviation 7.6
|
57.1 units on a scale
Standard Deviation 7.7
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week4
|
48.8 units on a scale
Standard Deviation 8.3
|
57.9 units on a scale
Standard Deviation 9.9
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week5
|
48.2 units on a scale
Standard Deviation 9.8
|
53.8 units on a scale
Standard Deviation 10.4
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week6
|
45.8 units on a scale
Standard Deviation 9.8
|
54.4 units on a scale
Standard Deviation 9.8
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week7
|
47.3 units on a scale
Standard Deviation 8.5
|
51.7 units on a scale
Standard Deviation 9.2
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week8
|
46.9 units on a scale
Standard Deviation 9.7
|
49.2 units on a scale
Standard Deviation 9.1
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week9
|
46.0 units on a scale
Standard Deviation 7.9
|
49.7 units on a scale
Standard Deviation 8.6
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week10
|
48.4 units on a scale
Standard Deviation 8.1
|
46.7 units on a scale
Standard Deviation 8.0
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week11
|
44.9 units on a scale
Standard Deviation 8.3
|
49.7 units on a scale
Standard Deviation 8.1
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week12
|
47.1 units on a scale
Standard Deviation 9.4
|
47.3 units on a scale
Standard Deviation 8.9
|
|
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
Week14
|
44.4 units on a scale
Standard Deviation 8.9
|
49.2 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
The useful field of view task is a computer-administered selective visual attention test that determines the minimum presentation time needed (between 16-500 msec) to correctly make two visual judgments: (a) is a centrally presented line drawing of a car or truck? and (b) where on the screen is a peripheral car located? Score is the fastest presentation time at which participants achieve at least 75% accuracy. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
Outcome measures
| Measure |
Brain Health
n=20 Participants
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
Participants in both interventions receive all study measures equivalently at all occasions
|
Mindfulness-inspired Treatment/Testing
n=20 Participants
Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.
Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment
|
|---|---|---|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week2
|
52.9 units on a scale
Standard Deviation 10.0
|
53.7 units on a scale
Standard Deviation 8.0
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week3
|
52.1 units on a scale
Standard Deviation 9.4
|
53.9 units on a scale
Standard Deviation 11.8
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week1
|
52.3 units on a scale
Standard Deviation 8.4
|
57.0 units on a scale
Standard Deviation 8.3
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week4
|
52.2 units on a scale
Standard Deviation 9.0
|
51.3 units on a scale
Standard Deviation 8.6
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week5
|
49.7 units on a scale
Standard Deviation 9.1
|
55.1 units on a scale
Standard Deviation 9.6
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week6
|
47.9 units on a scale
Standard Deviation 8.0
|
51.4 units on a scale
Standard Deviation 8.2
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week7
|
46.1 units on a scale
Standard Deviation 9.3
|
47.8 units on a scale
Standard Deviation 7.4
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week8
|
49.9 units on a scale
Standard Deviation 9.6
|
49.5 units on a scale
Standard Deviation 8.4
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week9
|
49.8 units on a scale
Standard Deviation 9.6
|
46.9 units on a scale
Standard Deviation 9.4
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week10
|
50.5 units on a scale
Standard Deviation 9.1
|
45.7 units on a scale
Standard Deviation 9.2
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week11
|
45.3 units on a scale
Standard Deviation 9.1
|
49.2 units on a scale
Standard Deviation 10.4
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week12
|
48.8 units on a scale
Standard Deviation 13.3
|
45.3 units on a scale
Standard Deviation 7.6
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week13
|
47.9 units on a scale
Standard Deviation 11.2
|
46.0 units on a scale
Standard Deviation 8.2
|
|
Performance in Useful Field of View Over 14 Weekly Measurements
Week14
|
48.1 units on a scale
Standard Deviation 11.5
|
47.2 units on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
This task set is computerized presents participants with a word (red or green or blue) that may be presented in (a) congruent (same) color as the word itself (e.g., red word is printed in red), or (b) incongruent (word red printed in green or blue). Participants are cued to either select the word or the color, this varies from trial to trial. Score is the reaction time difference between correct responses to congruent and incongruent stimuli. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
Outcome measures
| Measure |
Brain Health
n=20 Participants
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
Participants in both interventions receive all study measures equivalently at all occasions
|
Mindfulness-inspired Treatment/Testing
n=20 Participants
Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.
Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment
|
|---|---|---|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week1
|
51.5 units on a scale
Standard Deviation 8.6
|
54.7 units on a scale
Standard Deviation 9.0
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week2
|
53.6 units on a scale
Standard Deviation 8.4
|
49.5 units on a scale
Standard Deviation 12.0
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week3
|
50.8 units on a scale
Standard Deviation 11.0
|
49.2 units on a scale
Standard Deviation 12.1
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week4
|
52.9 units on a scale
Standard Deviation 10.1
|
51.3 units on a scale
Standard Deviation 11.4
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week5
|
50.7 units on a scale
Standard Deviation 8.9
|
50.0 units on a scale
Standard Deviation 10.2
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week6
|
50.9 units on a scale
Standard Deviation 9.1
|
51.0 units on a scale
Standard Deviation 8.2
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week7
|
49.8 units on a scale
Standard Deviation 8.1
|
50.0 units on a scale
Standard Deviation 13.1
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week8
|
49.5 units on a scale
Standard Deviation 9.8
|
49.0 units on a scale
Standard Deviation 7.9
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week9
|
47.3 units on a scale
Standard Deviation 10.5
|
51.6 units on a scale
Standard Deviation 9.5
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week10
|
49.4 units on a scale
Standard Deviation 9.2
|
45.8 units on a scale
Standard Deviation 8.8
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week11
|
50.9 units on a scale
Standard Deviation 12.5
|
50.0 units on a scale
Standard Deviation 10.1
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week12
|
47.0 units on a scale
Standard Deviation 8.9
|
45.1 units on a scale
Standard Deviation 7.3
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week13
|
48.9 units on a scale
Standard Deviation 10.8
|
51.1 units on a scale
Standard Deviation 9.2
|
|
Performance in Stroop Interference Over 14 Weekly Measurements
Week14
|
48.9 units on a scale
Standard Deviation 12.8
|
47.8 units on a scale
Standard Deviation 11.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Self-ratings of weeks 4, 5, 6, 7, 8, 9, 10, 11Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
Participants in both arms are asked, at the end of each of their eight intervention sessions, to focus on breathing. They are interrupted five times during this breathing exercise and asked what proportion of their attention (0-100) was wandering off the breathing task. Score is the average proportion of self-rated mind-wandering over five probes. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
Outcome measures
| Measure |
Brain Health
n=20 Participants
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
Participants in both interventions receive all study measures equivalently at all occasions
|
Mindfulness-inspired Treatment/Testing
n=20 Participants
Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.
Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment
|
|---|---|---|
|
Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
Week4
|
50.5 units on a scale
Standard Deviation 7.9
|
54.3 units on a scale
Standard Deviation 10.3
|
|
Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
Week5
|
50.6 units on a scale
Standard Deviation 7.7
|
51.7 units on a scale
Standard Deviation 9.6
|
|
Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
Week6
|
51.1 units on a scale
Standard Deviation 9.5
|
52.5 units on a scale
Standard Deviation 10.4
|
|
Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
Week7
|
50.7 units on a scale
Standard Deviation 11.5
|
49.7 units on a scale
Standard Deviation 10.2
|
|
Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
Week8
|
51.2 units on a scale
Standard Deviation 10.3
|
51.4 units on a scale
Standard Deviation 12.1
|
|
Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
Week9
|
50.9 units on a scale
Standard Deviation 10.7
|
47.5 units on a scale
Standard Deviation 10.1
|
|
Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
Week10
|
48.9 units on a scale
Standard Deviation 9.7
|
44.9 units on a scale
Standard Deviation 9.3
|
|
Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
Week11
|
46.0 units on a scale
Standard Deviation 7.7
|
44.2 units on a scale
Standard Deviation 8.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Self-ratings in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
Participants will answer computer 7 administered questions about anxiety in the past week. Score is a Likert-type scale response from the following scale: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)
Outcome measures
| Measure |
Brain Health
n=20 Participants
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
Participants in both interventions receive all study measures equivalently at all occasions
|
Mindfulness-inspired Treatment/Testing
n=20 Participants
Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.
Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment
|
|---|---|---|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week1
|
50.5 units on a scale
Standard Deviation 7.6
|
53.5 units on a scale
Standard Deviation 10.0
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week2
|
51.3 units on a scale
Standard Deviation 10.9
|
50.4 units on a scale
Standard Deviation 6.7
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week3
|
50.2 units on a scale
Standard Deviation 10.1
|
53.0 units on a scale
Standard Deviation 8.4
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week4
|
47.8 units on a scale
Standard Deviation 9.3
|
51.8 units on a scale
Standard Deviation 9.6
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week5
|
50.3 units on a scale
Standard Deviation 9.6
|
52.5 units on a scale
Standard Deviation 8.3
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week6
|
59.2 units on a scale
Standard Deviation 7.8
|
51.8 units on a scale
Standard Deviation 8.4
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week7
|
49.0 units on a scale
Standard Deviation 7.8
|
50.0 units on a scale
Standard Deviation 9.2
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week8
|
49.2 units on a scale
Standard Deviation 8.2
|
49.0 units on a scale
Standard Deviation 8.2
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week9
|
52.0 units on a scale
Standard Deviation 10.5
|
49.3 units on a scale
Standard Deviation 8.9
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week10
|
50.3 units on a scale
Standard Deviation 9.4
|
50.4 units on a scale
Standard Deviation 7.2
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week11
|
51.2 units on a scale
Standard Deviation 9.9
|
50.5 units on a scale
Standard Deviation 10.8
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week12
|
50.0 units on a scale
Standard Deviation 9.2
|
50 units on a scale
Standard Deviation 10
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week13
|
50.7 units on a scale
Standard Deviation 10.7
|
49.1 units on a scale
Standard Deviation 9.9
|
|
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
Week14
|
48.5 units on a scale
Standard Deviation 8.0
|
49.9 units on a scale
Standard Deviation 8.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Self-ratings weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
Cognitive and Affective Mindfulness Scale (CAMSr) will be computer administered. It is a psychological measurement to explore mindfulness. Each week ten items are rated on a 4-point Likert-type scale (1=rarely/never, 2=sometimes, 3=often, 4=almost always). Higher scores indicate greater cognitive and emotional focus. Scores are the average of the ten items, normalized and converted to T-score (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = better) metric.
Outcome measures
| Measure |
Brain Health
n=20 Participants
Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
Participants in both interventions receive all study measures equivalently at all occasions
|
Mindfulness-inspired Treatment/Testing
n=20 Participants
Eight weekly group mindfulness sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal mindfulness training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. Mindfulness activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice mindfulness on their own time, and to log this.
Participants receive all of the same measures as the active comparator "Brain Health" condition in Weeks 1-14. In weeks 4-11, participants receive Mindfulness Inspired Treatment
|
|---|---|---|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week1
|
48.8 units on a scale
Standard Deviation 8.3
|
48.8 units on a scale
Standard Deviation 8.5
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week2
|
49.4 units on a scale
Standard Deviation 9.9
|
50.3 units on a scale
Standard Deviation 8.8
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week3
|
49.9 units on a scale
Standard Deviation 10.9
|
47.7 units on a scale
Standard Deviation 7.6
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week4
|
53.3 units on a scale
Standard Deviation 9.3
|
46.0 units on a scale
Standard Deviation 10.1
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week5
|
51.3 units on a scale
Standard Deviation 11.6
|
47.0 units on a scale
Standard Deviation 8.8
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week6
|
51.2 units on a scale
Standard Deviation 7.8
|
48.6 units on a scale
Standard Deviation 8.5
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week7
|
50.7 units on a scale
Standard Deviation 9.7
|
49.7 units on a scale
Standard Deviation 9.4
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week8
|
49.0 units on a scale
Standard Deviation 11.1
|
50.3 units on a scale
Standard Deviation 10.2
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week9
|
50.0 units on a scale
Standard Deviation 11.0
|
47.9 units on a scale
Standard Deviation 11.0
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week10
|
50.3 units on a scale
Standard Deviation 8.8
|
49.7 units on a scale
Standard Deviation 11.6
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week11
|
51.8 units on a scale
Standard Deviation 10.0
|
48.7 units on a scale
Standard Deviation 13.2
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week12
|
50.9 units on a scale
Standard Deviation 9.3
|
48.5 units on a scale
Standard Deviation 9.6
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week13
|
51.6 units on a scale
Standard Deviation 8.8
|
51.4 units on a scale
Standard Deviation 9.0
|
|
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
Week14
|
51.4 units on a scale
Standard Deviation 10
|
51.3 units on a scale
Standard Deviation 10.6
|
Adverse Events
Brain Health
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mindfulness-inspired Treatment/Testing
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