Mental Training for Adults With Mild Cognitive Impairment

NCT03895346 | Completed

• 1 other identifier: 2018P002574
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the feasibility and acceptability of conducting a larger randomized clinical trial to test whether individuals with MCI can benefit from mental training programs.

Conditions

Mild Cognitive Impairment; Aging

Keywords

Mindfulness; Meditation; Imaging; MRI

Outcome Measures

Primary Outcomes (3)

• Recruitment feasibility

  Number of subjects recruited within 6 months; determine the number of people excluded for each inclusion/exclusion criterion; assessing reasons why eligible people decide not to enroll.

  6 months

• Retention

  Remaining in the study for the full duration of all testing time points (yes/no). Quantify the reasons for dropout

  6 months

• Adherence to study protocol

  Number of classes attended; number of times the subject practiced prescribed activities at home; number of people who complete each test/assessment.

  6 months

Study Arms (2)

Mindfulness

EXPERIMENTAL

Class meeting three times a week for six months, led by a certified mindfulness meditation instructor. Includes instruction and practice on techniques such as breathing, body scan, physical sensations, and yoga.

Behavioral: Mindfulness

Brain Games and Puzzles

ACTIVE COMPARATOR

Class meeting three times a week for six months, led by a qualified instructor. Includes teaching and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen.

Behavioral: Brain Games and Puzzles

Interventions

Mindfulness BEHAVIORAL

Mindfulness meditation is a technique of sustained attention and focus, involving preventing the mind from wandering from the meditative object (i.e. breath or body sensations)

Also known as: Meditation

Mindfulness

Brain Games and Puzzles BEHAVIORAL

Intervention will include the instruction and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen.

Brain Games and Puzzles

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CDR (clinical dementia rating) of 0.5
• years of age
• Able to speak, read, and understand English
• Willing to participate in a 6 month study and undergo 2 MRI scans at Mass General Hospital
• A score suggesting Mild Cognitive Impairment on the Telephone Interview for Cognitive Status (TICS)
• A Mini Mental State Exam adjusted for age and education of 24 to 30
• Stable medications for at least 30 days
• Subjects with well-controlled vascular risk factors such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels \< 250) will be included.
• Subjects with a history of cerebrovascular problems but have no persistent neurological deficits will be included
• Available for scheduled class times for both study courses
• Able to complete 40 minutes of homework per day during the 6-month course
• CDR (clinical dementia rating) of 0.5

You may not qualify if:

• CDR score other than 0.5
• Cardiovascular disease, stroke, congestive heart failure
• Has surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in eyes, cardiac pacemaker, non-removable nitroglycerin patch, non-MRI compatible cochlear implants, any other non-MRI compatible metal in body
• Has permanent bridgework in upper mouth that could interfere with MRI scan
• Active hematological, renal, pulmonary, endocrine, or hepatic disorders
• Uncontrolled high blood pressure
• Uncontrolled diabetes or insulin-treated diabetes (diabetes that is controlled with no more than one oral medication will be allowed)
• A history of neurological disease or injury, including a history of seizures or significant head trauma (i.e. extended loss of consciousness, bleeding in the brain, Parkinson's disease, stroke)
• Received treatment for cancer within the last year (skin cancer will be allowed as will any cancer more than 2 years since the last treatment)
• Diagnosis of schizophrenia, PTSD, bipolar disorder, or psychotic disorder at any point during lifetime
• Any axis I psychiatric disorder within the last 12 months
• Weighs more than 350 pounds
• Neurological or medical conditions that would interfere with study procedures or confound results, such as conditions that alter cerebral blood flow or metabolism
• Unstable medications or on medications with CNS effects including cholinesterase inhibitors, memantine, and antidepressants
• Use of psychotropic medications within 12 months prior to the study

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02119, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Mindfulness; Meditation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy

Study Officials

• Sara Lazar, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assessors will be masked to the group assignment of participants (mindfulness or brain games and puzzles).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 29, 2019
• Study Start: April 10, 2019
• Primary Completion: March 30, 2020
• Study Completion: December 31, 2021
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)