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This study aims to determine the feasibility and acceptability of conducting a larger randomized clinical trial to test whether individuals with MCI can benefit from mental training programs.
Half of participants will be randomized to a mindfulness group and half to a brain games and puzzles group as forms of mental training. Participants are adults with mild cognitive impairment. Participants will undergo neuropsychological testing, MRI scanning, and qualitative interviews to assess feasibility of conducting a larger randomized clinical trial in a population with mild cognitive impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Experimental | Class meeting three times a week for six months, led by a certified mindfulness meditation instructor. Includes instruction and practice on techniques such as breathing, body scan, physical sensations, and yoga. |
|
| Brain Games and Puzzles | Active Comparator | Class meeting three times a week for six months, led by a qualified instructor. Includes teaching and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | Mindfulness meditation is a technique of sustained attention and focus, involving preventing the mind from wandering from the meditative object (i.e. breath or body sensations) |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment feasibility | Number of subjects recruited within 6 months; determine the number of people excluded for each inclusion/exclusion criterion; assessing reasons why eligible people decide not to enroll. | 6 months |
| Retention | Remaining in the study for the full duration of all testing time points (yes/no). Quantify the reasons for dropout | 6 months |
| Adherence to study protocol | Number of classes attended; number of times the subject practiced prescribed activities at home; number of people who complete each test/assessment. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Lazar, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02119 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D019122 | Meditation |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Investigator and outcomes assessors will be masked to the group assignment of participants (mindfulness or brain games and puzzles).
|
| Brain Games and Puzzles | Behavioral | Intervention will include the instruction and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen. |
|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |