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The investigators are investigating the benefits of a mind/body intervention, Mindfulness Based Stress Reduction, for adults with Mild Cognitive Impairment.
We propose a prospective, randomized controlled pilot trial assessing the feasibility and safety of a study investigating mindfulness based stress reduction (MBSR) as an intervention in adults with Mild Cognitive Impairment (MCI). We are assessing safety and feasibility of this intervention, as well as using neuroimaging (fMRI) to assess improved connections in the default mode network. We will also be assessing the impact of this intervention on cognitive function and measures of well-being.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR | Experimental | Mindfulness Based Stress Reduction |
|
| Control Group | No Intervention | Continue in Usual care; offered the intervention at the end of the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Behavioral | 8 weekly classes of meditation/yoga |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Participants will inform us if they have had any adverse events during the study period and we will track to see if any occur for any of the participants | 8 weeks |
| Feasibility: 85% completion | To judge the feasibility of the trial, recruitment efforts will be documented in terms of number of eligible patients approached, number who declined participation, number successfullyl recruited, and number who completed the trial. The trial will be feasible if 85% (the absolute percentage of patients) complete the trial. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fMRI Resting state | Assessing fMRI resting state to assess if there are improved connections in the default mode network (between the posterior cingulate cortex, the medial prefrontal cortex, and the hippocampus) after participating in MBSR | Change from baseline to 8 weeks |
| Change in Cognition |
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Inclusion Criteria:
Clinical diagnosis of MCI* made by a neurologist (through history, physical exam and neuropsychological testing)
60-90 yo
Clinical Dementia Rating (CDR total score of 0.5, with at least 0.5 on memory subscale
No history of significant cerebrovascular disease based on Modified Hachinski score ≤ 4
Hamilton Depression Rating Scale score ≤12 (to rule out depression as a contributing cause of cognitive decline)
Able and willing to attend weekly sessions and willing to participate in daily mindfulness assignments, up to 45 min/day
Agreeable to participate and to be randomized to either group
Fluent in English (since the treatment groups will be run in English)
Adequate visual and auditory acuity to allow neuropsychological testing
Good general health with no additional diseases expected to interfere with the study
MRI/CT scan within 24 months without indication of infection, infarction, or focal lesions.
Family member/close friend ("informant") able to corroborate participant's history of memory loss
Participants may take stable doses (stable for at least 4 weeks prior to screening) of certain medications including:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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Assessing if there are any improvements in cognition (global functioning, episodic memory, attention, executive function, and language) after adults participate in MBSR. |
| Change from baseline to 8 weeks |
| Change in Measures of "well-being" | Assessing if there is any improvement in measures of well-being (quality of life, stress, anxiety, depression, rumination, neuroticism, optimism, hope, resilience, and mindfulness) after participating in MBSR | Change from baseline to 8 weeks |
| Qualitative Improvements | Semi-structured interviews will be conducted to assess if any qualitative improvements | 8 weeks |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D004191 |
| Behavioral Disciplines and Activities |