An interventional study of Cognitive Stimulation and Mindfulness training in Cognitive Health and Healthy Aging, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Other
Progress has been made in understanding the impact of different kinds of structured intervention programs in improving cognitive processing and performance in older adults, and in determining whether there is electrophysiological evidence for neuroplasticity in individuals over the age of 65.
Study Procedures
Pre-Intervention Assessment The initial screening evaluation will take place over two half-day sessions, each lasting 3 to 3.5 hours in a designated room in the Laboratory of Healthy Cognitive Aging, Center for Brain/Mind Medicine, Brigham and Women's Hospital (BWH), 221 Longwood Avenue, Boston, Massachusetts (MA).
The sessions can be completed over one or two days, depending on the subject's preference.
Pre-Intervention Assessment Session 1 The first session will include completion of informed consent, a medical history, demographic information, including socioeconomic status (SES), survey questionnaires, and tests of visual acuity.
Screening Evaluation (for inclusion/exclusion)
Cognitive Screen
Depression Screen Geriatric Depression Scale
Neurological/Physical Evaluation Subjects will undergo a structured neurological examination. Height and weight will be obtained to calculate BMI. Visual acuity will be measured (Snellen wall chart).
Gait
Gait will be assessed through a procedure in which subjects walk 10 meters under two conditions:
Every trial involving serial 3's will start from a different three digit number to reduce learning effects.
Subjects will be given an opportunity to carry out an untimed practice trial. Under the dual task condition, subjects will be instructed to perform as well as possible on both tasks (i.e., no specified prioritization). Each condition will be done 2 times, with the order counterbalanced across subjects. The first and last meter (gait start up and slow down) will not be counted in the measurements.
Time to walk 8 meters and number of steps taken will be measured. Under the dual task, investigators will also track how many numbers are generated while carrying out the serial 3's task (both correct and incorrect responses). In addition, the single task of counting backwards by 3's for 20 seconds will be tested twice in a seated position (once prior to and once after the gait testing).
Informant Questionnaire Subjects will select someone who knows them well (family member or friend) to complete a set of questionnaires. One questionnaire will provide information about a person's level of functioning (based on the Clinical Dementia Rating Scale), and another will inquire about a person's level of engagement (Apathy Scale). e questionnaires will be enclosed with a letter explaining how to complete the forms. The investigators will provide a stamped, addressed envelope to return the questionnaires to us. A backup plan will be to mail these materials directly to the informant selected. This would occur if the materials were misplaced or if the subject requests us to do so.
2,418 studies on the registry are indexed under Motor Activity; 1,162 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 2,111 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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Exclusion Criteria:
Subjects will complete computerized cognitive training with varying degrees of difficulty over 5 weeks.
Behavioral: Cognitive Stimulation
Subject participate in mindfulness training. The meditation and tasks will become increasingly more self-directed over the 5 weeks; the degree of guidance will decrease to keep the subjective effort approximately constant and moderately challenging through the 5 weeks.
Behavioral: Mindfulness training
Subjects will participate in a structured physical exercise training program that aims to progressively increase their level of activity over the 5 week training period.
Behavioral: Physical Activity
Subjects will complete the same computerized training as the active cognitive arm over the course of 5 weeks, but the main difference is that for the control group task difficulty will remain at the same low starting level, rather than increasing over time.
Behavioral: Control Group
During the initial session, a member of the research team will visit the subject's home and introduce the subject to the Cogmed training program (www.cogmed.com). Individuals will start at the same low difficulty level. As training proceeds, task difficulty will be individually adjusted based on performance by increasing/decreasing the number of items individuals have to remember, such that a participant reaches approximately 60% correct per day for each task. Each training session will start at the task difficulty level where the participant ended in the previous session. Performance and reaction time data will be continuously recorded while subjects are doing the task, and these data will be sent via the internet to the research team after each session. A member of the research team will communicate with each subject on a weekly basis (via phone call or email) to provide feedback and address any questions or concerns.
The mindfulness meditations will be narrated by one guide and the tasks will be narrated by a different guide. We will have 7 mindfulness tasks in total, whose order of presentation will be counterbalanced across sessions: 1. mindful observing of place, 2. mindful eating, 3. mindful observing of object, 4. mindful observing of person, 5. mindful walking, 6. mindful listening, and 7. mindful writing with the non-dominant and dominant hand. At the end of each session, participants will write brief reflections stored via the website (e.g., an estimate of the amount of time subjects experienced their thoughts as wandering) both as an integral part of the mindfulness process and as a means of increasing the likelihood that subjects fully participate in each session. Each session will be structured as follows: Login, Mindfulness Meditation Session, Mindfulness Task 1, Mindfulness Task 2, Mindfulness Task 3, Write Log Reflection, Logout.
Aerobic exercises will include relatively low impact activities like walking, jogging, or running in place, which will aim to put limited demands on balance. Each exercise will be explained and demonstrated in the video. All exercises can be done standing, sitting, or next to a chair that provides balance support as demonstrated in the videos. After the first session, for each subsequent session the difficulty level will start at one level below the previous session's average difficulty level (e.g. if they exercise at the most difficult level for most of the time during one session, the next session will start at the medium difficulty level). Each exercise will be explained and demonstrated in the video.
Individuals in the control group will participate in the same computerized Cogmed training program as described above. The main difference is that for the control group task difficulty will remain at the same low starting level, rather than increasing over time. The instructions given to subjects will be identical to the ones used in the cognitive training intervention.
Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions
* CANTAB Paired Associate Learning (PAL) - assesses visual memory and new learning * CANTAB Attention Switching Task (AST) - measures cued attentional set-shifting * CANTAB Reaction Time (RTI) - measures speed of response to visual target when the stimulus is either predictable (simple RT) or unpredictable (choice RT) * CANTAB Spatial Span (SSP) - assesses working memory * CANTAB One Touch Stockings of Cambridge (OTS) - a test of non-verbal reasoning
Time frame: Baseline
Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions
* CANTAB Paired Associate Learning (PAL) - assesses visual memory and new learning * CANTAB Attention Switching Task (AST) - measures cued attentional set-shifting * CANTAB Reaction Time (RTI) - measures speed of response to visual target when the stimulus is either predictable (simple RT) or unpredictable (choice RT) * CANTAB Spatial Span (SSP) - assesses working memory * CANTAB One Touch Stockings of Cambridge (OTS) - a test of non-verbal reasoning
Time frame: End of Study - 5 weeks post-baseline
Trail Making Test A
Tests of visual attention and task switching Timed task - Max time allotted: 150 seconds
Time frame: Baseline
Trail Making Test A
Tests of visual attention and task switching Timed task - Max time allotted: 150 seconds
Time frame: End of Study - 5 weeks post-baseline
Trail Making Test B
Tests of visual attention and task switching Timed task - Max time allotted: 300 seconds
Time frame: Baseline
Trail Making Test B
Tests of visual attention and task switching Timed - Max time allotted: 300 seconds
Time frame: End of Study - 5 weeks post-baseline
Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)
A test of processing speed 90 seconds allowed - Higher scores indicate faster processing speed Maximum Score: 91 Minimum Score: 0
Time frame: Baseline
Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)
A test of processing speed 90 seconds allowed - Higher scores indicate faster processing speed Maximum Score: 91 Minimum Score: 0
Time frame: End of Study - 5 weeks post-baseline
Controlled Oral Word Association Test (COWAT)
A test of verbal retrieval and word generation Total score is measured by calculating the total number of acceptable words produced for all three letters.
Time frame: Baseline
Controlled Oral Word Association Test (COWAT)
A test of verbal retrieval and word generation Total score is measured by calculating the total number of acceptable words produced for all three letters
Time frame: End of Study - 5 weeks post-baseline
Categorical Fluency
A test of rapid retrieval of semantic knowledge Scored by counting the number of correct unique semantic category items produced
Time frame: Baseline
Categorical Fluency
A test of rapid retrieval of semantic knowledge Scored by counting the number of correct unique semantic category items produced
Time frame: End of study - 5 weeks post-baseline
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Brigham and Women's Hospital