Mild Cognitive ImpairmentNCT01605448
Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment
A study testing Mindfulness Based Stress Reduction (MBSR) in people with Mild Cognitive Impairment, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The investigators are investigating the benefits of a mind/body intervention, Mindfulness Based Stress Reduction, for adults with Mild Cognitive Impairment. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Mindfulness Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The investigators are investigating the benefits of a mind/body intervention, Mindfulness Based Stress Reduction, for adults with Mild Cognitive Impairment.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Mindfulness Based Stress Reduction (MBSR)
- Keywords
- Mild Cognitive Impairment, Alzheimer's disease, Meditation, Default Mode Network
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction (MBSR)Behavioural
8 weekly classes of meditation/yoga
| Study group | Role | What they receive |
|---|---|---|
| MBSR | Experimental | Mindfulness Based Stress Reduction Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR) |
| Control Group | No intervention | Continue in Usual care; offered the intervention at the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 8 weeks
Secondary outcomes (4)
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
Measured: Change from baseline to 8 weeks
Change in Cognition
Assessing if there are any improvements in cognition (global functioning, episodic memory, attention, executive function, and language) after adults participate in MBSR.
Measured: 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
Measured: Change from baseline to 8 weeks
Qualitative Improvements
Semi-structured interviews will be conducted to assess if any qualitative improvements
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Wells, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605448
- Sponsor's protocol ID
- 2009P-000411
- Status last verified
- May 2012
- First submitted
- 13 May 2012
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01605448
- Acronym / sponsor ID
- 2009P-000411
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Alzheimer's disease, Meditation, Default Mode Network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are investigating the benefits of a mind/body intervention, Mindfulness Based Stress Reduction, for adults with Mild Cognitive Impairment.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: Mindfulness Based Stress Reduction (MBSR)Mindfulness Based Stress Reduction |
| Control Group | No intervention | –Continue in Usual care; offered the intervention at the end of the study |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR)8 weekly classes of meditation/yoga | Behavioural | MBSR |
Primary outcome
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
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.
4 secondary outcomes
Change in fMRI Resting state
Time frame: Change from baseline to 8 weeks
Change in Cognition
Time frame: Change from baseline to 8 weeks
Change in Measures of "well-being"
Time frame: Change from baseline to 8 weeks
Qualitative Improvements
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction (MBSR) in people with Mild Cognitive Impairment, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2012.