- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01605448
Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment
May 21, 2012 updated by: Rebecca Wells, Beth Israel Deaconess Medical Center
The investigators are investigating the benefits of a mind/body intervention, Mindfulness Based Stress Reduction, for adults with Mild Cognitive Impairment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Clinical diagnosis of MCI* made by a neurologist (through history, physical exam and neuropsychological testing)
- Memory complaint, corroborated by an informant
- Abnormal memory function documented by memory testing <1.5 standard deviation below normative controls (assessed with the Wechsler Memory scale IV[114], Logical Memory subtest, or an equivalent test)
- Normal general cognitive function
- Mini-Mental Status Exam (MMSE) score of >24 out of 30
- No/minimal impairment in activities of daily living
- Not sufficiently impaired, cognitively or functionally, to meet the National Institute of Neurological and Communicative Disease and Stroke/Alzheimer's Disease and Related Disorders Association criteria for AD
- 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:
- Antidepressants (except those with significant anticholinergic side effects such as tricyclic antidepressants). Patients cannot be currently depressed and or have a history of major depression within the past 2 years
- Cholinesterase inhibitors and memantine
Exclusion Criteria:
- Actively practicing meditation and/or yoga or have taken a meditation/yoga class in the last 6 months
- Any major systemic illness or unstable medical condition which could lead to difficulty complying with the protocol, including the diagnosis of major depression
- On psychoactive medications (antidepressants with anticholinergic effects, ie. tricyclic antidepressants, neuroleptics, chronic anxiolytics, sedative hypnotics, other anticholinergics); participants may take stable doses (stable for at least 6 months) of low doses of psychoactive medicines (i.e. ≤ 1mg klonipin/day or ≤25mg Benadryl/day)
- Psychotic features, agitation, or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol
- History of alcohol or substance abuse or dependence within the past 2 years
- Any history of brain lesions or major head trauma
- Participant unable/unwilling to follow the protocol or return for follow-up
- Investigational agents prohibited at entry and for the duration of the trial
- Participation in other clinical studies involving neuropsychological measures being collected more than one time per year
- MRI exclusions: presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MBSR
Mindfulness Based Stress Reduction
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8 weekly classes of meditation/yoga
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NO_INTERVENTION: Control Group
Continue in Usual care; offered the intervention at the end of the study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events
Time Frame: 8 weeks
|
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
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8 weeks
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Feasibility: 85% completion
Time Frame: 8 weeks
|
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.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fMRI Resting state
Time Frame: Change from baseline to 8 weeks
|
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
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Change from baseline to 8 weeks
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Change in Cognition
Time Frame: Change from baseline to 8 weeks
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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.
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Change from baseline to 8 weeks
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Change in Measures of "well-being"
Time Frame: Change from baseline to 8 weeks
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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
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Change from baseline to 8 weeks
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Qualitative Improvements
Time Frame: 8 weeks
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Semi-structured interviews will be conducted to assess if any qualitative improvements
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
May 1, 2011
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
May 13, 2012
First Submitted That Met QC Criteria
May 21, 2012
First Posted (ESTIMATE)
May 24, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 24, 2012
Last Update Submitted That Met QC Criteria
May 21, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009P-000411
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
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University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
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BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
-
Jennifer BramenNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Meir Medical CenterTerminatedMild Cognitive Impairment (MCI)Israel
Clinical Trials on Mindfulness Based Stress Reduction (MBSR)
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Duke UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Inflammation | Stress, Psychological | SleepUnited States
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Ottawa Hospital Research InstituteCanadian Cancer Society (CCS)CompletedCancer | Chronic Pain | Painful Neuropathy | Worries; Pain or DisabilityCanada
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University of AarhusCopenhagen University Hospital, HvidovreCompletedAn Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women.Pregnancy, High RiskDenmark
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University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)RecruitingArthritis, RheumatoidUnited States
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Azienda Socio Sanitaria Territoriale di LeccoRecruiting
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Women's College HospitalQueen's UniversityUnknownFeasibility Randomized Control TrialCanada
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University of MinnesotaFairview Health ServicesCompletedMyocardial Infarction | Heart Diseases | Heart Failure | Coronary Artery Bypass | Chronic Stable Angina | AngioplastyUnited States
-
Duquesne UniversityCompletedType 1 Diabetes Mellitus
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University of California, San FranciscoCompletedDementia | Frontotemporal Dementia | Frontotemporal Lobar Degeneration | Caregiver Stress Syndrome | Caregiver Burnout | Dementia Frontal | Mindfulness Based Stress ReductionUnited States
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University of SheffieldCompleted