Effects Multimodal Mind and Body Approach for MCI

NCT06814483 | Completed Phase 1 Results DMC

• 1 other identifier: 2022p003426
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Keywords

mind-body intervention; Baduanjin; Cognitive training

Outcome Measures

Primary Outcomes (4)

• Retention

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

  Through study intervention, an average of three months

• Fidelity

  session completed of total 30 classes

  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

  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).

  Through study interventions, an average of three months

Study Arms (2)

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

EXPERIMENTAL

cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation

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

a standard cognitive training

ACTIVE COMPARATOR

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

Behavioral: A standard cognitive training group

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 computer-based multimodal mind and body approach (cbMMBA)

A standard cognitive training group BEHAVIORAL

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

a standard cognitive training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• report of cognitive decline / complaint by the patient, the patient's informant, or the physician;
• 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;
• 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);
• not demented;

You may not qualify if:

• has severe visual or hearing impairment;
• has pre-existing musculoskeletal or other conditions, which prohibit BDJ performance and / or the application of acupressure at the selected points;
• 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;
• has had prior experience with BDJ or acupressure or relaxation techniques in the past year.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Bonnie Wong
• Organization: MGH

bonnie.wong@mgh.harvard.edu

617-7245708

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 7, 2025
• Study Start: December 11, 2023
• Primary Completion: April 11, 2025
• Study Completion: July 15, 2025
• Last Updated: March 9, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-02

Locations

US (1)