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Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction (MBSR)
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Alzheimer's disease, Meditation, Default Mode Network

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of MCI* made by a neurologist (through history, physical exam and neuropsychological testing)

    1. Memory complaint, corroborated by an informant
    2. 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)
    3. Normal general cognitive function
    4. Mini-Mental Status Exam (MMSE) score of >24 out of 30
    5. No/minimal impairment in activities of daily living
    6. 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.

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBSR

Control Group

Arm Description

Mindfulness Based Stress Reduction

Continue in Usual care; offered the intervention at the end of the study

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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 in Cognition
Assessing if there are any improvements in cognition (global functioning, episodic memory, attention, executive function, and language) after adults participate in MBSR.
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
Qualitative Improvements
Semi-structured interviews will be conducted to assess if any qualitative improvements

Full Information

First Posted
May 13, 2012
Last Updated
May 21, 2012
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01605448
Brief Title
Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment
Official Title
Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Alzheimer's disease, Meditation, Default Mode Network

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBSR
Arm Type
Experimental
Arm Description
Mindfulness Based Stress Reduction
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Continue in Usual care; offered the intervention at the end of the study
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction (MBSR)
Intervention Description
8 weekly classes of meditation/yoga
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
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
Time Frame
8 weeks
Title
Feasibility: 85% completion
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in fMRI Resting state
Description
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
Time Frame
Change from baseline to 8 weeks
Title
Change in Cognition
Description
Assessing if there are any improvements in cognition (global functioning, episodic memory, attention, executive function, and language) after adults participate in MBSR.
Time Frame
Change from baseline to 8 weeks
Title
Change in Measures of "well-being"
Description
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
Time Frame
Change from baseline to 8 weeks
Title
Qualitative Improvements
Description
Semi-structured interviews will be conducted to assess if any qualitative improvements
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment

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