Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rebecca Wells, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01605448
First received: May 13, 2012
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

The investigators are investigating the benefits of a mind/body intervention, Mindfulness Based Stress Reduction, for adults with Mild Cognitive Impairment.


Condition Intervention
Mild Cognitive Impairment
Behavioral: Mindfulness Based Stress Reduction (MBSR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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" [ Time Frame: Change from baseline to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Semi-structured interviews will be conducted to assess if any qualitative improvements


Enrollment: 14
Study Start Date: January 2010
Study Completion Date: January 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBSR
Mindfulness Based Stress Reduction
Behavioral: Mindfulness Based Stress Reduction (MBSR)
8 weekly classes of meditation/yoga
No Intervention: Control Group
Continue in Usual care; offered the intervention at the end of the study

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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605448

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Rebecca Wells, Instructor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01605448     History of Changes
Other Study ID Numbers: 2009P-000411
Study First Received: May 13, 2012
Last Updated: May 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Mild Cognitive Impairment
Alzheimer's disease
Meditation
Default Mode Network

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014