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Completed

NCT Number: NCT06814483

Effects Multimodal Mind and Body Approach for MCI

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

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 group

Behavioral

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

Primary outcomes

  1. Retention

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

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

  2. Fidelity

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

    session completed of total 30 classes

  3. Satisfaction to Intervention

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

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

  4. Number of Participants With Adverse Events

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

    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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Modulation Effects of a Computer-based Multimodal Mind and Body Approach for Mild Cognitive Decline

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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