DementiaNCT07843043
Feasibility of a Dyadic Music-based Intervention for Persons Living With Dementia and Their Care Partners
A study testing Dyadic Music-based Intervention (MBI) and Reminiscence Activity in people with Dementia, run by Duke University at 1 site in United States.
Trial summary
This study examines the feasibility, acceptability, and preliminary outcomes of a structured music-based intervention for individuals living with dementia and their family care partners. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Dyadic Music-based Intervention (MBI) and Reminiscence Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2027to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 and older
- Existing physician diagnosis of dementia or self-reported memory impairment and Telephone Montreal Cognitive Assessment (T-MoCA) score between 18-25 with a capacity to consent.
- Care partner or PLWD reporting current or past (8-12 months) dissatisfaction with the relationship (score of 3 or less on the relationship satisfaction measure), given that one member's dissatisfaction affects the other.
- Stable dose of psychotropic medications, sedatives/hypnotics, anti-dementia medications or opioids in the past 60 days to minimize the confounding effects of medications.
- Must reside with the patient.
- At least 21 years.
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- Self-identify as the primary care partner
- Able to speak and read English
- If on psychotropic medications at the time of telephone screen must be on a stable dose of the medication for 60 days prior to enrollment.
- Consider themselves a family member (blood or non-blood relative)
Who cannot join
- Hearing impairment (defined as inability to hear a normal speaking voice at a distance of 1-1/2 feet) to exclude those who cannot hear the music intervention.
- Planned transition to a residential or institutional care setting in less than 3 months (to decrease attrition).
- Currently enrolled in an interventional clinical trial for PLWD aimed to improve relationship quality (to not confound the results)
- Receiving hospice services.
- Do not reside with patient
- Under the age of 21 years of age
Show all 9Show fewer
- Is not primary care partner
- Not able to speak and read English
- Has not been on a stable dose of psychotropic medications for 60 days prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University
Durham, North Carolina, 27710
Darina Petrovsky, PhD, RN, 9196817041, PetrovskyResearch@duke.edu
About this study
Official title: The Feasibility of a Dyadic Music-Based Intervention for Persons Living With Dementia and Their Care Partners
This study examines the feasibility, acceptability, and preliminary outcomes of a structured music-based intervention for individuals living with dementia and their family care partners.
Read the detailed description
The dyadic MBI (adjusted in consultation with the Community Advisory Board) consists of training and support components centered on shared music listening. The interventionist will meet with the dyad once a week (frequency) for 45 minutes (dose) for 6 weeks (duration) to guide them through the weekly listening activity and provide support between sessions by email (per the dyad's preference). Dyads will be trained in 3 basic skills: 1) identifying personally-meaningful music, 2) approaching a mutual discussion of this music, and 3) engaging in shared music listening. Each session will follow a similar format.
- Conditions
- Dementia
- Being tested
- Dyadic Music-based Intervention (MBI), Reminiscence Activity
- Keywords
- Dementia, Music therapy, Caregivers
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Music-based Intervention (MBI)Behavioural
The dyadic MBI (adjusted in consultation with the Community Advisory Board) consists of training and support components centered on shared music listening. The interventionist will meet with the dyad once a week (frequency) for 45 minutes (dose) for 6 weeks (duration) to guide them through the weekly listening activity and provide support between sessions by email (per the dyad's preference). Dyads will be trained in 3 basic skills: 1) identifying personally-meaningful music, 2) approaching a mutual discussion of this music, and 3) engaging in shared music listening. Each session will follow a similar format.
Reminiscence ActivityBehavioural
The control condition intends to isolate the impact of music in the dyadic MBI and will consist of an object-based reminiscence activity shared by the dyad. The duration, dose, frequency, and timing in the control condition will match that of the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Persons Living With Dementia (PLWD) - Caregiver Dyads | Experimental | The interventionist will meet with the PLWD and their care partner via Zoom to identify and build a playlist of the PLWD's preferred music on a mobile device. The interventionist will use Gerdner's Assessment of Personal Music to learn about preferred genres, music artists, and types of music, and also review the PLWD's CDs, vinyl records, cassettes, and other music media to identify music. Receives: Behavioral: Dyadic Music-based Intervention (MBI) |
| Reminiscence activity | Placebo comparator | Not described Receives: Behavioral: Reminiscence Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of dyads who complete at least 4 out of 6 music/control condition sessions
Measured: Up to the end of treatment, 6 weeks
Percentage of dyads who rate the music/control condition sessions after intervention as highly acceptable/satisfactory (the average score is greater than 3)
Researchers will evaluate the acceptability of each condition using the Acceptability of Intervention Measure (AIM). The AIM has 4 statements on a 5-point Likert scale, on which responses range from 1=completely disagree to 5=completely agree.
Measured: Up to the end of treatment, 6 weeks
Secondary outcomes (8)
Reasons for dyad drop out
The reason why the dyad decided to drop out will be documented
Measured: Up to the end of treatment, 6 weeks
Number of dyads screened per month
Recruitment will be assessed as number of dyads screened per month
Measured: Through study completion, an average of 1 year
Number of dyads enrolled per month
Measured: Through study completion, an average of 1 year
Percentage of eligible dyads who enroll
Enrollment success will be calculated as percent of eligible dyads who enroll
Measured: At enrollment
Percentage of dyads who enroll and agree to be randomized
Measured: At enrollment
Percentage of dyads who complete baseline and follow-up measures
Measured: Up to the end of treatment, 6 weeks
Percentage of sessions delivered according to the protocol
The study team will audit 20% of cases for feedback and adherence checks using an already-developed fidelity checklist from prior work.
Measured: Up to the end of treatment, 6 weeks
Percentage of measures that are completed at baseline and post intervention
Data collection burden will be reported as the percent of measures that are completed at baseline and post intervention.
Measured: Up to the end of treatment, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Aug 2027 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Darina Petrovsky, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843043
- Sponsor's protocol ID
- Pro00120103
- Other IDs
- 1R34AT013824
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Dyadic Music-Based Intervention for Persons Living With Dementia and Their Care Partners
- ClinicalTrials.gov ID
- NCT07843043
- Acronym / sponsor ID
- Pro00120103
- Conditions
- Dementia
- Keywords
- Dementia, Music therapy, Caregivers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Aug 2027 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the feasibility, acceptability, and preliminary outcomes of a structured music-based intervention for individuals living with dementia and their family care partners.
Detailed description
The dyadic MBI (adjusted in consultation with the Community Advisory Board) consists of training and support components centered on shared music listening. The interventionist will meet with the dyad once a week (frequency) for 45 minutes (dose) for 6 weeks (duration) to guide them through the weekly listening activity and provide support between sessions by email (per the dyad's preference). Dyads will be trained in 3 basic skills: 1) identifying personally-meaningful music, 2) approaching a mutual discussion of this music, and 3) engaging in shared music listening. Each session will follow a similar format.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons Living With Dementia (PLWD) - Caregiver Dyads | Experimental | Behavioral: Dyadic Music-based Intervention (MBI)The interventionist will meet with the PLWD and their care partner via Zoom to identify and build a playlist of the PLWD's preferred music on a mobile device. The interventionist will use Gerdner's Assessment of Personal Music to learn about preferred genres, music artists, and types of music, and also review the PLWD's CDs, vinyl records, cassettes, and other music media to identify music. |
| Reminiscence activity | Placebo comparator | Behavioral: Reminiscence Activity |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 60 and older
- Existing physician diagnosis of dementia or self-reported memory impairment and Telephone Montreal Cognitive Assessment (T-MoCA) score between 18-25 with a capacity to consent.
- Care partner or PLWD reporting current or past (8-12 months) dissatisfaction with the relationship (score of 3 or less on the relationship satisfaction measure), given that one member's dissatisfaction affects the other.
- Stable dose of psychotropic medications, sedatives/hypnotics, anti-dementia medications or opioids in the past 60 days to minimize the confounding effects of medications.
- Must reside with the patient.
Key exclusion criteria (9 listed)
- Hearing impairment (defined as inability to hear a normal speaking voice at a distance of 1-1/2 feet) to exclude those who cannot hear the music intervention.
- Planned transition to a residential or institutional care setting in less than 3 months (to decrease attrition).
- Currently enrolled in an interventional clinical trial for PLWD aimed to improve relationship quality (to not confound the results)
- Receiving hospice services.
- Do not reside with patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic Music-based Intervention (MBI)The dyadic MBI (adjusted in consultation with the Community Advisory Board) consists of training and support components centered on shared music listening. The interventionist will meet with the dyad once a week (frequency) for 45 minutes (dose) for 6 weeks (duration) to guide them through the weekly listening activity and provide support between sessions by email (per the dyad's preference). Dyads will be trained in 3 basic skills: 1) identifying personally-meaningful music, 2) approaching a mutual discussion of this music, and 3) engaging in shared music listening. Each session will follow a similar format. | Behavioural | Persons Living With Dementia (PLWD) - Caregiver Dyads |
| Reminiscence ActivityThe control condition intends to isolate the impact of music in the dyadic MBI and will consist of an object-based reminiscence activity shared by the dyad. The duration, dose, frequency, and timing in the control condition will match that of the intervention group. | Behavioural | Reminiscence activity |
Primary outcome
Percentage of dyads who complete at least 4 out of 6 music/control condition sessions
Time frame: Up to the end of treatment, 6 weeks
Percentage of dyads who rate the music/control condition sessions after intervention as highly acceptable/satisfactory (the average score is greater than 3)
Time frame: Up to the end of treatment, 6 weeks
Researchers will evaluate the acceptability of each condition using the Acceptability of Intervention Measure (AIM). The AIM has 4 statements on a 5-point Likert scale, on which responses range from 1=completely disagree to 5=completely agree.
8 secondary outcomes
Reasons for dyad drop out
Time frame: Up to the end of treatment, 6 weeks
Number of dyads screened per month
Time frame: Through study completion, an average of 1 year
Number of dyads enrolled per month
Time frame: Through study completion, an average of 1 year
Percentage of eligible dyads who enroll
Time frame: At enrollment
Percentage of dyads who enroll and agree to be randomized
Time frame: At enrollment
Percentage of dyads who complete baseline and follow-up measures
Time frame: Up to the end of treatment, 6 weeks
Percentage of sessions delivered according to the protocol
Time frame: Up to the end of treatment, 6 weeks
Percentage of measures that are completed at baseline and post intervention
Time frame: Up to the end of treatment, 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darina Petrovsky principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic Music-based Intervention (MBI) and Reminiscence Activity in people with Dementia, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of dyads who complete at least 4 out of 6 music/control condition sessions (time frame: Up to the end of treatment, 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.