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Different cognitive intervention approaches have been developed to attenuate decline (e.g., cognitive engagement, training, or stimulation), but it is not clear which approaches are efficacious. It is also not clear when, along the continuum of normal cognitive aging to mild cognitive impairment (MCI-a transitional stage before dementia onset), it is most efficacious to intervene. This randomized clinical trial will determine the efficacy of a novel cognitive engagement intervention approach (music training) as compared to cognitive stimulation (which will serve as a stringent, active control). Grounded in theory, the central hypothesis is that interventions enhancing central auditory processing (CAP), a strong, longitudinal predictor of MCI and dementia, will improve cognition. Music training is increasingly recognized as a feasible means to attenuate age-related cognitive decline. Prior research and preliminary data suggest that intense piano training enhances CAP and is likely more effective than cognitive stimulation. Correlational studies indicate superior CAP, executive function, and other cognitive abilities for adults with formal music training compared to non-musicians. The specific aims of the study are to examine the efficacy of music training relative to cognitive stimulation (active controls) to improve CAP, cognition, and everyday function among older adults with and without MCI. The efficacy of music training will be established and moderating effects of MCI status will be examined. The proposed study further aims to elucidate the underlying mechanisms of effective cognitive intervention approaches by exploring mediators of training gains. The proposed study is the first phase II randomized trial of music training to enhance older adults' cognition. Mediation analyses will elucidate the underlying mechanisms of intervention effects.
Interventions to Attenuate Cognitive Decline: Keys to Staying Sharp.
The primary objectives is to examine the efficacy of music training to improve central auditory processing (CAP), cognition, and everyday function among older adults.
The secondary objectives are:
Design The design is a two arm randomized clinical trial examining the efficacy of music training to improve CAP, cognition, and everyday function in older adults with and without MCI across two time points (baseline and immediate post-test).
Outcomes The effects of of music training on CAP, cognition, and everyday functional performance will be quantified.
CAP processing measures will include: Time Compressed Speech 65%, Words-in-Noise, Dichotic Digits Test, Dichotic Sentence Identification, and Adaptive Tests of Temporal Resolution. A composite will be derived from principal components analyses.
Cognition measures will include: Verbal Fluency Test (phonemic fluency, category fluency, and category switching), Trail Making Test, and Digit Coding. A composite will be derived from principal component analyses.
Everyday Function measures will include: Timed Instrumental Activities of Daily Living and Test of Everyday Attention. A composite will be derived from principal component analyses.
Interventions and Duration Two types of music training will be investigated. The two training conditions will be equivalent in terms of frequency and duration of each session (90 min/day, two days/wk, 10 weeks) and social contact (led by trainer and conducted in groups of up to 10 persons).
Sample Size and Population In-person screening of a maximum of 500 potential study participants are planned to enroll up to 400 participants. The goal is to have at least 200 participants complete the study. Individuals with normal cognition and those with a clinical diagnosis of MCI will be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Training I | Experimental | Participants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument. |
|
| Music Training II | Active Comparator | Participants will complete a type of music training including listening to music, learning about music, or learning to read music, or play a musical instrument |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Training I | Behavioral | Participants will be attending group classes, guided by a trainer, with up to 10 other older adults. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognition | A composite of performance on Verbal fluency words generated, Trail Making Test time, and Digit Symbol Coding number correct derived from principal components analyses | change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central Auditory Processing | A composite will be formed from principal components analyses of number correct for performance on Time Compressed Speech Test (TCS), Words-in-Noise Test (WIN), Dichotic Digits Test (DDT), Dichotic Sentence Identification (DSI) and the threshold in ms of performance on the Adaptive Tests of Temporal Resolution (ATTR). | change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| General Self Efficacy | General Self-Efficacy scale likert scaling with higher numbers reflecting better self efficacy. 23 items on a 14-point scale. Items will be summed. Items are designed to reflect effort, initiation, and persistence as described by Bandura | Change from prior to training content exercises to immediately after training content exercises, at the end of intervention phase which is about three months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33620 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41453521 | Derived | Runge SK, Hudak EM, Sutfin JA, Dobrovolskiy VR, Edwards JD. The influence of peer navigators on intervention adherence and retention among older adults: A study within a randomized trial - SWAT. Contemp Clin Trials. 2026 Feb;161:108206. doi: 10.1016/j.cct.2025.108206. Epub 2025 Dec 24. | |
| 31226405 | Derived | Hudak EM, Bugos J, Andel R, Lister JJ, Ji M, Edwards JD. Keys to staying sharp: A randomized clinical trial of piano training among older adults with and without mild cognitive impairment. Contemp Clin Trials. 2019 Sep;84:105789. doi: 10.1016/j.cct.2019.06.003. Epub 2019 Jun 18. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2018 | Jan 4, 2023 | Prot_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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| Everyday Function | A composite will be formed from the time and accuracy of performance on the Timed IADL Test and The Test of Everyday Attention (TEA) | change from baseline to immediate post intervention at the end of study completion which is a period of about 6 months |
| Music Self Efficacy | Music Self-Efficacy scale likert scaling with higher numbers reflecting better music self efficacy. 24 items with liker scaling of 1 to 100. Total across all items will be summed. Items reflect the degree to which participants have positive feelings and beliefs in their musical abilities. | Change from prior to training content exercises to immediately after training content exercises, at the end of intervention phase which is about three months |