Cognitive Aging
Conditions
Keywords
Cognitive Aging, Attention, Mindfulness
Brief summary
Attentional control, or individuals' ability to choose which stimuli in the environment they attend to and which they ignore, declines with older age. Studies from the past two decades suggest that mindfulness meditative practice, such as a standardized mindfulness based stress reduction programs, may increase the efficiency of attention networks.To date, the majority of studies that have related mindfulness meditation practice to attentional control have been based on retrospective self-reported mindfulness or cross-sectional measurement in experienced meditators. More recent experimental studies using pre-post training designs have shown that meditation-naïve individuals can experience attentional improvement with mindfulness intervention. This study seeks to elucidate the time course and process by which such attentional improvements might be achieved. This research study investigates change in attentional control as participants progress through an 8-week mindfulness-inspired training (MIT) intervention, and has two specific aims: 1) to determine the time course of change in attentional components such as cognitive control and sustained attention as a consequence of MIT; attention will be measured weekly for 3 weeks before, 3 weeks after, and during 8 weeks of MIT. 2) To investigate the extent to which change in attentional performance is coupled/correlated with markers of emotion regulation, perceived mindfulness, and perceived mind wandering.
Detailed description
This will be a 14-week research study exploring week to week changes in attentional control and selected time-varying covariates. The study will involve comparison of two groups of adults aged 65 and older. Half the participants (n=20) will be randomized to received eight weeks of mindfulness-inspired training, while the other half (n=20) are not. Groups will be compared in the amount of change experienced in measures of attentional control. In addition, the association between changes in emotion regulation, perceived mindfulness, and perceived mind wandering with changes in attentional control will be examined, as well as whether this association differs between persons who did and did not receive mindfulness-inspired training. Measurement will include both paper-and-pencil and computer-administered tests.
Interventions
BEHAVIORALMindfulness-inspired treatment
Eight weekly group MIT 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 MIT 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. MIT 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 MIT on their own time, and to log this.
OTHERBrain 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.
Sponsors
National Institute on Aging (NIA)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to provide informed consent and perform cognitive and behavioral (mindfulness) interventions; * Time and willingness to commit to the completion of this study; * Ability to read at an 8th grade level based on scores on the Wechsler Test of Adult Reading (WTAR) and reading text at 14 point font
Exclusion criteria
* Lack of time and willingness to commit to the completion of this 14-week study * Less than an 8th grade education * Having been told by a healthcare provider that they (1) have had a stroke or mini-stroke in the past 12 months, (2) have ever had a traumatic brain injury, (3) have had schizophrenia or psychosis, (4) have problem with alcohol or substance abuse * extreme difficulty reading ordinary print in a newspaper, or have stopped reading due to poor eyesight. * extreme difficulty hearing, or being completely unable to hear, ordinary speech in low-noise conditions, even with hearing aid. * Currently participating in cognitive training or brain training * Having participated in any cognitive or brain training study within the last 6 months * Currently participating in yoga or meditation based practices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance in Useful Field of View Over 14 Weekly Measurements | Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | 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) |
| Performance in Stroop Interference Over 14 Weekly Measurements | Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Self-ratings of weeks 4, 5, 6, 7, 8, 9, 10, 11 | 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) |
| Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Self-ratings in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | 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) |
| Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Self-ratings weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| 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 treatment. | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Brain Health | Total | Mindfulness-inspired Treatment/Testing |
|---|---|---|---|
| Age, Continuous | 72.75 years STANDARD_DEVIATION 4.83 | 73.85 years STANDARD_DEVIATION 15.98 | 74.95 years STANDARD_DEVIATION 6.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 42 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 37 Participants | 19 Participants |
| Region of Enrollment United States | 21 participants | 42 participants | 21 participants |
| Sex: Female, Male Female | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements
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)
Time frame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week1 | 51.6 units on a scale | Standard Deviation 14.4 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week2 | 51.2 units on a scale | Standard Deviation 11.7 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week3 | 50.4 units on a scale | Standard Deviation 7.6 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week4 | 48.8 units on a scale | Standard Deviation 8.3 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week5 | 48.2 units on a scale | Standard Deviation 9.8 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week6 | 45.8 units on a scale | Standard Deviation 9.8 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week7 | 47.3 units on a scale | Standard Deviation 8.5 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week8 | 46.9 units on a scale | Standard Deviation 9.7 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week9 | 46.0 units on a scale | Standard Deviation 7.9 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week10 | 48.4 units on a scale | Standard Deviation 8.1 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week11 | 44.9 units on a scale | Standard Deviation 8.3 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week12 | 47.1 units on a scale | Standard Deviation 9.4 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week13 | 45.0 units on a scale | Standard Deviation 9.4 |
| Brain Health | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week14 | 44.4 units on a scale | Standard Deviation 8.9 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week11 | 49.7 units on a scale | Standard Deviation 8.1 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week1 | 60.4 units on a scale | Standard Deviation 8 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week8 | 49.2 units on a scale | Standard Deviation 9.1 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week2 | 57.3 units on a scale | Standard Deviation 10.9 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week13 | 50.4 units on a scale | Standard Deviation 8.8 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week3 | 57.1 units on a scale | Standard Deviation 7.7 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week9 | 49.7 units on a scale | Standard Deviation 8.6 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week4 | 57.9 units on a scale | Standard Deviation 9.9 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week12 | 47.3 units on a scale | Standard Deviation 8.9 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week5 | 53.8 units on a scale | Standard Deviation 10.4 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week10 | 46.7 units on a scale | Standard Deviation 8 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week6 | 54.4 units on a scale | Standard Deviation 9.8 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week14 | 49.2 units on a scale | Standard Deviation 7.3 |
| Mindfulness-inspired Treatment/Testing | Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements | Week7 | 51.7 units on a scale | Standard Deviation 9.2 |
Comparison: Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. First-order Autoregressive was best (which specifies homogeneous variance over time but allows one correlation between occasions).p-value: 0.024Mixed Models Analysis
Secondary
Performance in Stroop Interference Over 14 Weekly Measurements
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)
Time frame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week1 | 51.5 units on a scale | Standard Deviation 8.6 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week2 | 53.6 units on a scale | Standard Deviation 8.4 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week3 | 50.8 units on a scale | Standard Deviation 11 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week4 | 52.9 units on a scale | Standard Deviation 10.1 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week5 | 50.7 units on a scale | Standard Deviation 8.9 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week6 | 50.9 units on a scale | Standard Deviation 9.1 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week7 | 49.8 units on a scale | Standard Deviation 8.1 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week8 | 49.5 units on a scale | Standard Deviation 9.8 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week9 | 47.3 units on a scale | Standard Deviation 10.5 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week10 | 49.4 units on a scale | Standard Deviation 9.2 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week11 | 50.9 units on a scale | Standard Deviation 12.5 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week12 | 47.0 units on a scale | Standard Deviation 8.9 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week13 | 48.9 units on a scale | Standard Deviation 10.8 |
| Brain Health | Performance in Stroop Interference Over 14 Weekly Measurements | Week14 | 48.9 units on a scale | Standard Deviation 12.8 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week11 | 50.0 units on a scale | Standard Deviation 10.1 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week1 | 54.7 units on a scale | Standard Deviation 9 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week8 | 49.0 units on a scale | Standard Deviation 7.9 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week2 | 49.5 units on a scale | Standard Deviation 12 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week13 | 51.1 units on a scale | Standard Deviation 9.2 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week3 | 49.2 units on a scale | Standard Deviation 12.1 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week9 | 51.6 units on a scale | Standard Deviation 9.5 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week4 | 51.3 units on a scale | Standard Deviation 11.4 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week12 | 45.1 units on a scale | Standard Deviation 7.3 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week5 | 50.0 units on a scale | Standard Deviation 10.2 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week10 | 45.8 units on a scale | Standard Deviation 8.8 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week6 | 51.0 units on a scale | Standard Deviation 8.2 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week14 | 47.8 units on a scale | Standard Deviation 11.4 |
| Mindfulness-inspired Treatment/Testing | Performance in Stroop Interference Over 14 Weekly Measurements | Week7 | 50.0 units on a scale | Standard Deviation 13.1 |
Secondary
Performance in Useful Field of View Over 14 Weekly Measurements
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)
Time frame: Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week1 | 52.3 units on a scale | Standard Deviation 8.4 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week2 | 52.9 units on a scale | Standard Deviation 10 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week3 | 52.1 units on a scale | Standard Deviation 9.4 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week4 | 52.2 units on a scale | Standard Deviation 9 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week5 | 49.7 units on a scale | Standard Deviation 9.1 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week6 | 47.9 units on a scale | Standard Deviation 8 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week7 | 46.1 units on a scale | Standard Deviation 9.3 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week8 | 49.9 units on a scale | Standard Deviation 9.6 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week9 | 49.8 units on a scale | Standard Deviation 9.6 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week10 | 50.5 units on a scale | Standard Deviation 9.1 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week11 | 45.3 units on a scale | Standard Deviation 9.1 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week12 | 48.8 units on a scale | Standard Deviation 13.3 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week13 | 47.9 units on a scale | Standard Deviation 11.2 |
| Brain Health | Performance in Useful Field of View Over 14 Weekly Measurements | Week14 | 48.1 units on a scale | Standard Deviation 11.5 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week11 | 49.2 units on a scale | Standard Deviation 10.4 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week1 | 57.0 units on a scale | Standard Deviation 8.3 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week8 | 49.5 units on a scale | Standard Deviation 8.4 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week2 | 53.7 units on a scale | Standard Deviation 8 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week13 | 46.0 units on a scale | Standard Deviation 8.2 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week3 | 53.9 units on a scale | Standard Deviation 11.8 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week9 | 46.9 units on a scale | Standard Deviation 9.4 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week4 | 51.3 units on a scale | Standard Deviation 8.6 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week12 | 45.3 units on a scale | Standard Deviation 7.6 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week5 | 55.1 units on a scale | Standard Deviation 9.6 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week10 | 45.7 units on a scale | Standard Deviation 9.2 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week6 | 51.4 units on a scale | Standard Deviation 8.2 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week14 | 47.2 units on a scale | Standard Deviation 9.4 |
| Mindfulness-inspired Treatment/Testing | Performance in Useful Field of View Over 14 Weekly Measurements | Week7 | 47.8 units on a scale | Standard Deviation 7.4 |
Comparison: Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).p-value: 0.333Mixed Models Analysis
Other Pre-specified
Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements
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)
Time frame: Self-ratings in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week1 | 50.5 units on a scale | Standard Deviation 7.6 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week2 | 51.3 units on a scale | Standard Deviation 10.9 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week3 | 50.2 units on a scale | Standard Deviation 10.1 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week4 | 47.8 units on a scale | Standard Deviation 9.3 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week5 | 50.3 units on a scale | Standard Deviation 9.6 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week6 | 59.2 units on a scale | Standard Deviation 7.8 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week7 | 49.0 units on a scale | Standard Deviation 7.8 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week8 | 49.2 units on a scale | Standard Deviation 8.2 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week9 | 52.0 units on a scale | Standard Deviation 10.5 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week10 | 50.3 units on a scale | Standard Deviation 9.4 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week11 | 51.2 units on a scale | Standard Deviation 9.9 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week12 | 50.0 units on a scale | Standard Deviation 9.2 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week13 | 50.7 units on a scale | Standard Deviation 10.7 |
| Brain Health | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week14 | 48.5 units on a scale | Standard Deviation 8 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week11 | 50.5 units on a scale | Standard Deviation 10.8 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week1 | 53.5 units on a scale | Standard Deviation 10 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week8 | 49.0 units on a scale | Standard Deviation 8.2 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week2 | 50.4 units on a scale | Standard Deviation 6.7 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week13 | 49.1 units on a scale | Standard Deviation 9.9 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week3 | 53.0 units on a scale | Standard Deviation 8.4 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week9 | 49.3 units on a scale | Standard Deviation 8.9 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week4 | 51.8 units on a scale | Standard Deviation 9.6 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week12 | 50 units on a scale | Standard Deviation 10 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week5 | 52.5 units on a scale | Standard Deviation 8.3 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week10 | 50.4 units on a scale | Standard Deviation 7.2 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week6 | 51.8 units on a scale | Standard Deviation 8.4 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week14 | 49.9 units on a scale | Standard Deviation 8.3 |
| Mindfulness-inspired Treatment/Testing | Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements | Week7 | 50.0 units on a scale | Standard Deviation 9.2 |
Comparison: Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).p-value: 0.448Mixed Models Analysis
Other Pre-specified
Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements
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)
Time frame: Self-ratings of weeks 4, 5, 6, 7, 8, 9, 10, 11
Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brain Health | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week4 | 50.5 units on a scale | Standard Deviation 7.9 |
| Brain Health | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week5 | 50.6 units on a scale | Standard Deviation 7.7 |
| Brain Health | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week6 | 51.1 units on a scale | Standard Deviation 9.5 |
| Brain Health | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week7 | 50.7 units on a scale | Standard Deviation 11.5 |
| Brain Health | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week8 | 51.2 units on a scale | Standard Deviation 10.3 |
| Brain Health | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week9 | 50.9 units on a scale | Standard Deviation 10.7 |
| Brain Health | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week10 | 48.9 units on a scale | Standard Deviation 9.7 |
| Brain Health | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week11 | 46.0 units on a scale | Standard Deviation 7.7 |
| Mindfulness-inspired Treatment/Testing | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week11 | 44.2 units on a scale | Standard Deviation 8.7 |
| Mindfulness-inspired Treatment/Testing | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week4 | 54.3 units on a scale | Standard Deviation 10.3 |
| Mindfulness-inspired Treatment/Testing | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week8 | 51.4 units on a scale | Standard Deviation 12.1 |
| Mindfulness-inspired Treatment/Testing | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week5 | 51.7 units on a scale | Standard Deviation 9.6 |
| Mindfulness-inspired Treatment/Testing | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week10 | 44.9 units on a scale | Standard Deviation 9.3 |
| Mindfulness-inspired Treatment/Testing | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week6 | 52.5 units on a scale | Standard Deviation 10.4 |
| Mindfulness-inspired Treatment/Testing | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week9 | 47.5 units on a scale | Standard Deviation 10.1 |
| Mindfulness-inspired Treatment/Testing | Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements | Week7 | 49.7 units on a scale | Standard Deviation 10.2 |
Comparison: Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).p-value: 0.001Mixed Models Analysis
Other Pre-specified
Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements
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.
Time frame: Self-ratings weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Population: Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week1 | 48.8 units on a scale | Standard Deviation 8.3 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week2 | 49.4 units on a scale | Standard Deviation 9.9 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week3 | 49.9 units on a scale | Standard Deviation 10.9 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week6 | 51.2 units on a scale | Standard Deviation 7.8 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week4 | 53.3 units on a scale | Standard Deviation 9.3 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week5 | 51.3 units on a scale | Standard Deviation 11.6 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week7 | 50.7 units on a scale | Standard Deviation 9.7 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week8 | 49.0 units on a scale | Standard Deviation 11.1 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week9 | 50.0 units on a scale | Standard Deviation 11 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week10 | 50.3 units on a scale | Standard Deviation 8.8 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week11 | 51.8 units on a scale | Standard Deviation 10 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week12 | 50.9 units on a scale | Standard Deviation 9.3 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week13 | 51.6 units on a scale | Standard Deviation 8.8 |
| Brain Health | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week14 | 51.4 units on a scale | Standard Deviation 10 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week11 | 48.7 units on a scale | Standard Deviation 13.2 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week1 | 48.8 units on a scale | Standard Deviation 8.5 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week8 | 50.3 units on a scale | Standard Deviation 10.2 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week2 | 50.3 units on a scale | Standard Deviation 8.8 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week13 | 51.4 units on a scale | Standard Deviation 9 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week3 | 47.7 units on a scale | Standard Deviation 7.6 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week9 | 47.9 units on a scale | Standard Deviation 11 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week12 | 48.5 units on a scale | Standard Deviation 9.6 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week4 | 46.0 units on a scale | Standard Deviation 10.1 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week10 | 49.7 units on a scale | Standard Deviation 11.6 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week5 | 47.0 units on a scale | Standard Deviation 8.8 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week6 | 48.6 units on a scale | Standard Deviation 8.5 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week14 | 51.3 units on a scale | Standard Deviation 10.6 |
| Mindfulness-inspired Treatment/Testing | Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements | Week7 | 49.7 units on a scale | Standard Deviation 9.4 |
Comparison: Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).p-value: 0.439Mixed Models Analysis