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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| a standard cognitive training | Active Comparator | The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129 | United States |
The Small Business Act permits SBIR/STTR grantees to withhold data for 4 years after the end of the grant award.
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| ID | Title | Description |
|---|---|---|
| FG000 | A Computer-based Multimodal Mind and Body Approach (cbMMBA) | cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation. |
| FG001 | a Standard Cognitive Training | The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A Computer-based Multimodal Mind and Body Approach (cbMMBA) | cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention | Proportion of subjects who complete all assessments from the total number of subjects started the first intervention | Posted | Count of Participants | Participants | Through study intervention, an average of three months |
|
6 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A Computer-based Multimodal Mind and Body Approach (cbMMBA) | cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation Experimental: A computer-based multimodal mind and body approach (cbMMBA): cbMMBA will include three modules: BDJ, acupressure, and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| planned heart surgery | Cardiac disorders | Systematic Assessment | unrelated to intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Wong | MGH | 617-7245708 | bonnie.wong@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2024 | Jan 10, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2024 | Jan 10, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| A standard cognitive training group | Behavioral | The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects |
|
| BG001 | a Standard Cognitive Training | The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects |
| BG002 | Total | Total of all reporting groups |
| year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects |
|
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| Primary | Fidelity | session completed of total 30 classes | Posted | Mean | Standard Deviation | session | Through study interventions, an average of three months |
|
|
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| Primary | Satisfaction to Intervention | average score in a 1-5 scale, 5 indicates very satisfied with the intervention | Posted | Mean | Standard Deviation | points in a 1-5 scale | Through study interventions, an average of three months |
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| Primary | 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). | Posted | Count of Participants | Participants | Through study interventions, an average of three months |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 2 |
| 17 |
| EG001 | a Standard Cognitive Training | The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects A standard cognitive training group: The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects | 0 | 15 | 0 | 15 | 0 | 15 |
| PTSD recurrence | Psychiatric disorders | Systematic Assessment | unrelated to the intervention |
|
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