Mindfulness Based Stress Reduction for Adults With Mild Cognitive Impairment

NCT01605448 | Completed

• 1 other identifier: 2009P-000411
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Alzheimer's disease; Meditation; Default Mode Network

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Change in fMRI Resting state

  Change from baseline to 8 weeks

• Change in Cognition

  Change from baseline to 8 weeks

• Change in Measures of "well-being"

  Change from baseline to 8 weeks

• Qualitative Improvements

  8 weeks

Study Arms (2)

MBSR

EXPERIMENTAL

Mindfulness Based Stress Reduction

Behavioral: Mindfulness Based Stress Reduction (MBSR)

Control Group

NO INTERVENTION

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

Interventions

Mindfulness Based Stress Reduction (MBSR) BEHAVIORAL

8 weekly classes of meditation/yoga

MBSR

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: May 13, 2012
• First Posted: May 24, 2012
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: January 1, 2012
• Last Updated: May 24, 2012

Record last verified: 2012-05

Locations

US (1)