Effects Multimodal Mind and Body Approach for MCI

Massachusetts General Hospital32 enrolled

Overview

The aim of this application is to develop a computer-based multimodal mind and body approach (CMMBA) for mild cognitive impairment (MCI). This product will provide a new, cost-effective and easily accessible treatment option for MCI and potentially other age-related dementia.

The goal of this Phase I R41 (STTR) application is to develop a computer-based multimodal mind and body approach (cbMMBA) to improve the cognitive function for mild cognitive impairment (MCI). This application, if successful, will provide a cost-effective and easily accessible treatment option for MCI and other age-related dementia, significantly improve the prevention of MCI development, and directly benefit patients suffering from the highly prevalent disorder, particularly for those who may have limited access to in-person mind and body interventions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Mild Cognitive Impairment

Interventions

Experimental: A computer-based multimodal mind and body approach (cbMMBA)BEHAVIORAL

cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation.

A standard cognitive training groupBEHAVIORAL

The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. report of cognitive decline / complaint by the patient, the patient's informant, or the physician; 2. cognitive impairment is confirmed by objective cognitive measures (Montreal Cognitive Assessment (MoCA) and neuropsychological testing), where objective cognitive impairment is defined as poor performance in one or more cognitive measures suggesting deficit in one or more cognitive domains; 3. patient has preserved independence in functional abilities (measured by informant report, completion of Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) checklists); 4. not demented; Exclusion Criteria: 1. has severe visual or hearing impairment; 2. has pre-existing musculoskeletal or other conditions, which prohibit BDJ performance and / or the application of acupressure at the selected points; 3. has suffered from a neurological disorder (e.g., severe head trauma), psychiatric disease (e.g., major depression), or any other major medical disease that could potentially compromise their cognition; 4. has had prior experience with BDJ or acupressure or relaxation techniques in the past year.

Locations (1)

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Outcomes

Primary Outcomes

Retention

Proportion of subjects who complete all assessments from the total number of subjects started the first intervention

Time frame: Through study intervention, an average of three months

Fidelity

session completed of total 30 classes

Time frame: Through study interventions, an average of three months

Satisfaction to Intervention

average score in a 1-5 scale, 5 indicates very satisfied with the intervention

Time frame: Through study interventions, an average of three months

Number of Participants With Adverse Events

Adverse events were assessed by participant self-report at each study visit. An adverse event was defined as any unfavorable or unintended sign, symptom, or medical occurrence temporally associated with study participation, regardless of attribution. This outcome reports the number of participants who experienced ≥1 adverse event during the study period (each participant counted once).

Time frame: Through study interventions, an average of three months

Data from ClinicalTrials.gov

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