Aging WellMelo-SWellNCT06219148
Music Therapy and Social Work Telehealth for Older Adult Well-Being
A study testing Music Therapy Telehealth, Non-Collaborative Social Work Telehealth and Collaborative Social Work Telehealth in people with Aging Well and Dementia, run by Alaine E Hernandez, PhD at 2 sites in United States.
Trial summary
This study investigates the benefits of using telehealth services, specifically a combination of music therapy and social work support, to improve the well-being of older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Well, Dementia, Telemedicine
- What is being tested?
- Music Therapy Telehealth, Non-Collaborative Social Work Telehealth and Collaborative Social Work Telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Mar 2024to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 or older
- English-speaking
- reside in Kentucky
- willing to receive support from the research team on how to access Zoom (as needed)
- EITHER a) have familiarity using digital technology and/or a video conferencing app such as Zoom, FaceTime, or Facebook Messenger, OR b) have a family member or friend who can facilitate Zoom access (i.e., "helper").
Who cannot join
- substance use disorder, which could present a confounding variable relative to the aims;
- significant sensory impairment that interferes with Zoom use
- current music therapy and/or social work case manager recipient
- HELPERS: facilitate participation by older adults who are unfamiliar with using video conferencing technology and/or who lack consent capacity.
- Helper Inclusion Criteria:
- at least 18 years old
Show all 12Show fewer
- cognitively unimpaired
- live with or be able to go to the older adult's residence to assist them in participating in the study.
- Helper Exclusion Criteria:
- under 18 years old
- cognitively impaired
- unable to assist the older adult in participating in the study for any reason
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40506
Saint Louis University
St Louis, Missouri, 63103
About this study
Official title: A Pilot Study to Evaluate the Effectiveness of a Collaborative Music Therapy and Social Work Telehealth Framework to Address the Well-Being of Community- Dwelling Older Adults
This study investigates the benefits of using telehealth services, specifically a combination of music therapy and social work support, to improve the well-being of older adults. Investigators are focusing on outcomes such as reduced loneliness, improved cognition, and how well older adults with and without dementia perceive the quality of the services received. This research is crucial because as the population ages and conditions like Alzheimer's become more prevalent, effective psychosocial interventions are needed.
The collaborative telehealth approach of the intervention in this study strives to connect older adults to community and health-related services. Older adults experience challenges in accessing services related to transportation, social support, and finances. While the pandemic prompted a rapid shift of healthcare services online, including music therapy and social work, questions remain about the quality of this transition, especially for older adults who may not be familiar with or have the resources for telehealth.
In this pilot study, investigators are studying music therapy and social work support through telehealth to understand how this approach can impact the well-being, cognition, and service quality for older adults, both with and without dementia. Social workers, who focus on improving well-being and addressing various needs, can leverage the therapeutic relationship built by music therapists to better identify and meet service needs. This pilot study builds on a feasibility project, which indicated that this collaborative framework is acceptable, valuable, and of interest to older adults, facilitating remote community connection. Through this research, investigators aim to evaluate the effectiveness of telehealth services for older adults to inform a future larger trial.
Read the detailed description
The goal of this quantitative pilot study is to evaluate the effectiveness of a collaborative music therapy and social work telehealth framework for community-dwelling older adults with and without dementia with regards to their emotions, well-being, cognition, and perceived service quality. This pilot study builds on a feasibility study that field tested logistics and provided proof-of-concept of the novel telehealth framework. Specifically, the feasibility study evaluated the acceptability, barriers, and facilitators of this framework for older adults with and without dementia. Both music-based interventions were grounded in the person-centered Clinical Practice Model for Persons with Dementia, which provides guidelines for adjusting the degree of support and challenge offered to an individual. The investigators developed a collaborative social work referral worksheet. The investigators conducted semi-structured qualitative interviews with participants and care partners, who offered input about all aspects of the study. The investigators also refined recruitment, data collection, protocol training, and intervention processes. This pilot study builds on this past feasibility work.
Older adults often experience changes in health, finances, and social support which impede community involvement. Social distancing surrounding COVID-19 exacerbated such hurdles and enhanced risk for loneliness, depression, and cognitive decline. Although many services including music therapy and social work transitioned from in-person to telehealth during the pandemic, the rapid shift suggests that innovation occurred reactively, without sufficient time to evaluate the quality or effectiveness of this service delivery model. Telehealth is likely to continue to be a component of the music therapy profession and more broadly in healthcare. With thoughtful and systematic development to bridge the digital divide, telehealth may offer some benefit to community-dwelling older adults. This goal may be accomplished through interprofessional collaboration. Music therapists can address psychosocial needs through a variety of flexible and age-appropriate music experiences, while social workers have expertise to reach isolated individuals and connect them to appropriate supports. This pilot study advances a line of research to test a novel telehealth framework that integrates social work and music therapy to promote older adult well-being.
In this quantitative pilot study, the investigators will test methods and procedures that will be used in a future larger clinical trial to enhance the rigor and reproducibility of this research. The objectives of this pilot study are to examine the effects of the collaborative telehealth framework on older adults' well-being (primary aim), cognition, loneliness, perception of service quality, and (in response to music therapy) emotions, and to gather preliminary data for effect size estimation. Participants and interventionists will be invited to engage in a semi-structured qualitative interview at the conclusion of the study to inform further optimization of the collaborative telehealth framework. Participants have the option to use their own or borrow equipment (iPads). To reach those with limited resources, there will be 2 iPads with cellular data available to ship to enable study participation. Participants will be community-dwelling older adults with and without dementia. All participants will receive music therapy via telehealth and social work wellness sessions via telehealth. Collaboration is the key difference in the levels of independent variable: participants will be randomly assigned to either a collaborative condition, or non-collaborative condition. In the collaborative condition, information collected during music therapy will inform social work wellness sessions following a protocol developed during the feasibility study. In the non-collaborative condition, social workers and music therapists will operate telehealth services independently.
- Conditions
- Aging Well, Dementia, Telemedicine
- Being tested
- Music Therapy Telehealth, Non-Collaborative Social Work Telehealth, Collaborative Social Work Telehealth
- Keywords
- Music Therapy, Social Work, Evidence-Based Practice, Quality of Life, Emotion, Cognition, Loneliness, Collaboration
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Therapy TelehealthBehavioural
Also called Music-based intervention (MBI)
Music Therapy: delivered via Zoom by a board-certified music therapist (MT-BC) 30-min 2x/week for 4 weeks (8 sessions total); follows the Clinical Practice Model, which guides customizations of various music experiences (e.g., singing, songwriting, movement, relaxation, lyric discussion, improvisation, instrument play, etc.) per participants' strengths, interests, preferences, culture, and momentary responses. Each participant works with the same MT-BC throughout the study.
Non-Collaborative Social Work TelehealthBehavioural
Also called Independent social work intervention, independent wellness support
Social Work: delivered via Zoom by a licensed social worker (SW) or supervised SW graduate student 3x for 30-min: 1) after 2 weeks MT (assessment), 2) after 4 weeks MT (service referral), 3) 2-week follow-up. SWs operate independently from MT-BCs to identify possible participant service referral needs using the Aging and Memory Quality of Life Survey (AMQoL), baseline data, SW session interactions, and SW Referral Worksheet. Each participant works with the same SW throughout the study.
Collaborative Social Work TelehealthBehavioural
Also called Integrative social work intervention, integrative wellness support
Social Work: delivered via Zoom by a licensed SW or supervised SW graduate student 3x for 30-min: 1) after 2 weeks MT (assessment), 2) after 4 weeks MT (service referral), 3) 2-week follow-up. In addition to the AMQoL, baseline data, SW session interactions, and the SW Referral Worksheet, SWs collaborate fully with MT-BCs, have full access MT session notes, and can discuss participants' needs with MT-BC to identify possible participant service referral needs. Each participant works with the same SW throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative | Experimental | Social workers and music therapists work together, and information collected during music therapy informs social work wellness sessions following a protocol developed during the feasibility study.
There are 3 blocks of activities, identical to the non-collaborative arm:
* Weeks 1-2: enrollment, stratification, random assignment
* Weeks 3-6: music therapy and social work interventions
* Weeks 7-8: social work follow up. Receives: Behavioral: Music Therapy Telehealth; Behavioral: Collaborative Social Work Telehealth |
| Non-Collaborative | Sham comparator | Social workers and music therapists operate independently.
There are 3 blocks of activities, identical to the collaborative arm:
* Weeks 1-2: enrollment, stratification, random assignment
* Weeks 3-6: music therapy and social work interventions
* Weeks 7-8: social work follow up. Receives: Behavioral: Music Therapy Telehealth; Behavioral: Non-Collaborative Social Work Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index at 6 Weeks
A simple 5-item measure of subjective well-being (a combination of feeling good and functioning well). The participant rates each item on a 6-point scale from 0 (at no time) to 5 (all of the time); total raw score ranges from 0 (worst possible) to 25 (best possible well-being); percentage score (raw X 4) ranges from 0 (worst possible) to 100 (best possible well-being). Administered by outcome assessor by phone or Zoom at participant's preference.
Measured: Enrollment, end of Week 6.
Mean Change from Baseline in WHO-5 Well-Being Index at 8 Weeks
A simple 5-item measure of subjective well-being (a combination of feeling good and functioning well). The participant rates each item on a 6-point scale from 0 (at no time) to 5 (all of the time); total raw score ranges from 0 (worst possible) to 25 (best possible well-being); percentage score (raw X 4) ranges from 0 (worst possible) to 100 (best possible well-being). Administered by outcome assessor by phone or Zoom at participant's preference.
Measured: Enrollment, end of Week 8.
Secondary outcomes (9)
Mean Change in Self-Reported Feelings for Participants with Dementia
Administered by music therapists. For participants who score less than 18 on the Montreal Cognitive Assessment (MoCA): The Dementia Mood Picture Test (DMPT) measures self-reported feelings of persons with mild, moderate, or severe dementia using simple, enlarged face drawings with verbal descriptors for 6 emotions: good mood, bad mood, happy, sad, angry, and worried. The person with dementia rates each emotion on a 3-point scale from 0 (do not feel that emotion) to 2 (feel that emotion a lot); total score ranges from 0 (most negative) to 12 (most positive; with negative valence emotions reverse-scored).
Measured: Immediately before and immediately after each music therapy session.
Mean Change in Self-Reported Feelings for Participants without Dementia
Administered by music therapists. For participants who score 18 or greater on the MoCA: analogous Likert-type scale for the same 6 DMPT items: good mood, bad mood, happy, sad, angry, and worried, scored from 0 (do not feel that emotion) to 6 (feel that emotion a lot); total score ranges from 0 (most negative) to 36 (most positive).
Measured: Immediately before and immediately after each music therapy session.
Mean Change from Baseline in University of California, Los Angeles (UCLA) Loneliness Scale at 6 Weeks
The UCLA Loneliness Scale (Version 3) is a 20-item scale designed to measure subjective feelings of loneliness and social isolation. Participants rate each item on a 4-point scale from 1 (Never) to 4 (Often). Total score ranges from 20 (lower loneliness) to 80 (higher loneliness). Administered by outcome assessor by phone or Zoom at participant's preference.
Measured: Enrollment, end of Week 6.
Mean Change from Baseline in UCLA Loneliness Scale at 8 Weeks
The UCLA Loneliness Scale (Version 3) is a 20-item scale designed to measure subjective feelings of loneliness and social isolation. Participants rate each item on a 4-point scale from 1 (Never) to 4 (Often). Total score ranges from 20 (lower loneliness) to 80 (higher loneliness). Administered by outcome assessor by phone or Zoom at participant's preference.
Measured: Enrollment, end of Week 8.
Mean Change from Baseline in Montreal Cognitive Assessment (MoCA) at 6 Weeks
Cognitive screening tool with scores ranging from 0 (greatly impaired) to 30 (unimpaired). The researchers will use the Audio-Visual Conference version as a brief estimate of change in cognitive status over the course of the study. Those who score less than 18 will be labeled as "with dementia" for the purposes of random assignment, and the researchers will use the following descriptive severity categories: > 25 = no impairment, 18-25 = mild impairment, 10-17= moderate impairment, < 10 = severe impairment. Administered by outcome assessor by Zoom.
Measured: Enrollment, end of Week 6.
Program Evaluation Total Score
The researchers will use a 12-item Quality Questionnaire concerning quality, willingness to try, and helpfulness of music therapy, social work, telehealth, and the overall program. Each item uses a 5-point Likert-type scale from 1 (Poor/extremely unwilling/extremely unhelpful) to 5 (Excellent/extremely willing/extremely helpful). Total score ranges from 12 (worst) to 60 (best). Administered by outcome assessor by phone or Zoom at participant's preference.
Measured: Within 1 week of final social work session.
Program Evaluation Quality Score
The researchers will analyze 4 quality items from the Quality Questionnaire concerning quality of music therapy, quality of social work, quality of telehealth, and quality of the overall program. Each item uses a 5-point Likert-type scale from 1 (Poor) to 5 (Excellent). Total score for quality ranges from 4 (poorest quality) to 20 (best quality). Administered by outcome assessor by phone or Zoom at participant's preference.
Measured: Within 1 week of final social work session.
Program Evaluation Willingness Score
The researchers will analyze 4 quality items from the Quality Questionnaire concerning willingness to try music therapy, social work, telehealth, and the overall program in the future. Each item uses a 5-point Likert-type scale from 1 (extremely unwilling) to 5 (extremely willing). Total score for willingness ranges from 4 (most unwilling) to 20 (most willing). Administered by outcome assessor by phone or Zoom at participant's preference.
Measured: Within 1 week of final social work session.
Program Evaluation Helpfulness Score
The researchers will analyze 4 quality items from the Quality Questionnaire concerning helpfulness of music therapy, social work, telehealth, and the overall program. Each item uses a 5-point Likert-type scale from 1 (extremely unhelpful) to 5 (extremely helpful). Total score for helpfulness ranges from 4 (most unhelpful) to 20 (most helpful). Administered by outcome assessor by phone or Zoom at participant's preference.
Measured: Within 1 week of final social work session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start19 Mar 2024
- Primary completion14 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aging WellStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To ensure a balanced number of individuals in each study condition, a research team member will stratify participants as "with" or "without" dementia according to either their self-reported physician's diagnosis or score on the MoCA (score \<18 = "with dementia"). Participants will then be randomly assigned to either the collaborative or non-collaborative condition using a random number table.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaine E Hernandez, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- American Music Therapy Association
- Responsible party
- Sponsor-investigator, Alaine E Hernandez, PhD, University of Kentucky
- Investigators
- Alaine E Reschke-Hernandez, PhD, Principal investigator, University of KentuckyAllison Gibson, PhD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219148
- Sponsor's protocol ID
- 63233
- Other IDs
- Arthur Flagler Fultz Award
- Acronym
- Melo-SWell
- Status last verified
- Aug 2025
- First submitted
- 12 Jan 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is a small pilot study. Pilot data for preliminary effect size estimating will not be publicly shared. Researchers may request de-identified data and study materials from the principal investigator.
Publications
Lam K, Lu AD, Shi Y, Covinsky KE. Assessing Telemedicine Unreadiness Among Older Adults in the United States During the COVID-19 Pandemic. JAMA Intern Med. 2020 Oct 1;180(10):1389-1391. doi: 10.1001/jamainternmed.2020.2671.
PubMed 32744593Kistin C, Silverstein M. Pilot Studies: A Critical but Potentially Misused Component of Interventional Research. JAMA. 2015 Oct 20;314(15):1561-2. doi: 10.1001/jama.2015.10962. No abstract available.
PubMed 26501530Gibson A, Bardach SH, Pope ND. COVID-19 and the Digital Divide: Will Social Workers Help Bridge the Gap? J Gerontol Soc Work. 2020 Aug-Oct;63(6-7):671-673. doi: 10.1080/01634372.2020.1772438. Epub 2020 Jun 5. No abstract available.
PubMed 32500841Ng BP, Park C, Silverman CL, Eckhoff DO, Guest JC, Diaz DA. Accessibility and utilisation of telehealth services among older adults during COVID-19 pandemic in the United States. Health Soc Care Community. 2022 Sep;30(5):e2657-e2669. doi: 10.1111/hsc.13709. Epub 2022 Jan 6.
PubMed 34994028Reschke-Hernández, A. E. (2019). A clinical practice model of music therapy to address psychosocial functioning for persons with dementia: Model development and randomized clinical crossover trial (NCT03643003). Doctoral dissertation, University of Iowa. https://doi.org/10.17077/etd.59oh-y06y
Reschke-Hernández, A. E. (2021). The Clinical Practice Model for Persons with Dementia: Application to music therapy. Music Therapy Perspectives, 39(2), 133-141. https://doi.org/10.1093/mtp/miab006
Reschke-Hernández, A. E., Gibson, A., Buckner, L. E., Sullivan, A. C., Posey, C., & Uecker, S. (2023). Development of a collaborative music therapy and social work telehealth framework to address the well-being of community-dwelling older adults. Research poster presented at: Alzheimer's Association International Conference, Amsterdam, Netherlands, 16-20 July 2023.
Wilhelm, L., & Wilhelm, K. (2022). Telehealth music therapy services in the United States with older adults: A descriptive study. Music Therapy Perspectives. Advance online publication. https://doi.org/10.1093/mtp/miab028
World Health Organization. (2017, December 7). Global action plan on the public health response to dementia 2017-2025. https://tinyurl.com/bdhm6wha
World Health Organization. (2010, September 1). Framework for action on interprofessional education and collaborative practice (WHO Reference Number WHO/HRH/HPN/10.3). https://tinyurl.com/28ykjrn3
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effectiveness of a Collaborative Music Therapy and Social Work Telehealth Framework to Address the Well-Being of Community- Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06219148
- Acronym / sponsor ID
- Melo-SWell / 63233
- Conditions
- Aging Well, Dementia, Telemedicine
- Keywords
- Music Therapy, Social Work, Evidence-Based Practice, Quality of Life, Emotion, Cognition, Loneliness, Collaboration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alaine E Hernandez, PhDUniversity, hospital or other
- Collaborators
- American Music Therapy Association
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 23 Jan 2024 (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 investigates the benefits of using telehealth services, specifically a combination of music therapy and social work support, to improve the well-being of older adults. Investigators are focusing on outcomes such as reduced loneliness, improved cognition, and how well older adults with and without dementia perceive the quality of the services received. This research is crucial because as the population ages and conditions like Alzheimer's become more prevalent, effective psychosocial interventions are needed.
The collaborative telehealth approach of the intervention in this study strives to connect older adults to community and health-related services. Older adults experience challenges in accessing services related to transportation, social support, and finances. While the pandemic prompted a rapid shift of healthcare services online, including music therapy and social work, questions remain about the quality of this transition, especially for older adults who may not be familiar with or have the resources for telehealth.
In this pilot study, investigators are studying music therapy and social work support through telehealth to understand how this approach can impact the well-being, cognition, and service quality for older adults, both with and without dementia. Social workers, who focus on improving well-being and addressing various needs, can leverage the therapeutic relationship built by music therapists to better identify and meet service needs. This pilot study builds on a feasibility project, which indicated that this collaborative framework is acceptable, valuable, and of interest to older adults, facilitating remote community connection. Through this research, investigators aim to evaluate the effectiveness of telehealth services for older adults to inform a future larger trial.
Detailed description
The goal of this quantitative pilot study is to evaluate the effectiveness of a collaborative music therapy and social work telehealth framework for community-dwelling older adults with and without dementia with regards to their emotions, well-being, cognition, and perceived service quality. This pilot study builds on a feasibility study that field tested logistics and provided proof-of-concept of the novel telehealth framework. Specifically, the feasibility study evaluated the acceptability, barriers, and facilitators of this framework for older adults with and without dementia. Both music-based interventions were grounded in the person-centered Clinical Practice Model for Persons with Dementia, which provides guidelines for adjusting the degree of support and challenge offered to an individual. The investigators developed a collaborative social work referral worksheet. The investigators conducted semi-structured qualitative interviews with participants and care partners, who offered input about all aspects of the study. The investigators also refined recruitment, data collection, protocol training, and intervention processes. This pilot study builds on this past feasibility work.
Older adults often experience changes in health, finances, and social support which impede community involvement. Social distancing surrounding COVID-19 exacerbated such hurdles and enhanced risk for loneliness, depression, and cognitive decline. Although many services including music therapy and social work transitioned from in-person to telehealth during the pandemic, the rapid shift suggests that innovation occurred reactively, without sufficient time to evaluate the quality or effectiveness of this service delivery model. Telehealth is likely to continue to be a component of the music therapy profession and more broadly in healthcare. With thoughtful and systematic development to bridge the digital divide, telehealth may offer some benefit to community-dwelling older adults. This goal may be accomplished through interprofessional collaboration. Music therapists can address psychosocial needs through a variety of flexible and age-appropriate music experiences, while social workers have expertise to reach isolated individuals and connect them to appropriate supports. This pilot study advances a line of research to test a novel telehealth framework that integrates social work and music therapy to promote older adult well-being.
In this quantitative pilot study, the investigators will test methods and procedures that will be used in a future larger clinical trial to enhance the rigor and reproducibility of this research. The objectives of this pilot study are to examine the effects of the collaborative telehealth framework on older adults' well-being (primary aim), cognition, loneliness, perception of service quality, and (in response to music therapy) emotions, and to gather preliminary data for effect size estimation. Participants and interventionists will be invited to engage in a semi-structured qualitative interview at the conclusion of the study to inform further optimization of the collaborative telehealth framework. Participants have the option to use their own or borrow equipment (iPads). To reach those with limited resources, there will be 2 iPads with cellular data available to ship to enable study participation. Participants will be community-dwelling older adults with and without dementia. All participants will receive music therapy via telehealth and social work wellness sessions via telehealth. Collaboration is the key difference in the levels of independent variable: participants will be randomly assigned to either a collaborative condition, or non-collaborative condition. In the collaborative condition, information collected during music therapy will inform social work wellness sessions following a protocol developed during the feasibility study. In the non-collaborative condition, social workers and music therapists will operate telehealth services independently.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- To ensure a balanced number of individuals in each study condition, a research team member will stratify participants as "with" or "without" dementia according to either their self-reported physician's diagnosis or score on the MoCA (score <18 = "with dementia"). Participants will then be randomly assigned to either the collaborative or non-collaborative condition using a random number table.
| Arm | Type | Receives |
|---|---|---|
| Collaborative | Experimental | Behavioral: Music Therapy Telehealth, Behavioral: Collaborative Social Work TelehealthSocial workers and music therapists work together, and information collected during music therapy informs social work wellness sessions following a protocol developed during the feasibility study. There are 3 blocks of activities, identical to the non-collaborative arm: * Weeks 1-2: enrollment, stratification, random assignment * Weeks 3-6: music therapy and social work interventions * Weeks 7-8: social work follow up. |
| Non-Collaborative | Sham comparator | Behavioral: Music Therapy Telehealth, Behavioral: Non-Collaborative Social Work TelehealthSocial workers and music therapists operate independently. There are 3 blocks of activities, identical to the collaborative arm: * Weeks 1-2: enrollment, stratification, random assignment * Weeks 3-6: music therapy and social work interventions * Weeks 7-8: social work follow up. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- age 65 or older
- English-speaking
- reside in Kentucky
- willing to receive support from the research team on how to access Zoom (as needed)
- EITHER a) have familiarity using digital technology and/or a video conferencing app such as Zoom, FaceTime, or Facebook Messenger, OR b) have a family member or friend who can facilitate Zoom access (i.e., "helper").
Key exclusion criteria (12 listed)
- substance use disorder, which could present a confounding variable relative to the aims;
- significant sensory impairment that interferes with Zoom use
- current music therapy and/or social work case manager recipient
- HELPERS: facilitate participation by older adults who are unfamiliar with using video conferencing technology and/or who lack consent capacity.
- at least 18 years old
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 |
|---|---|---|
| Music Therapy TelehealthAlso: Music-based intervention (MBI)Music Therapy: delivered via Zoom by a board-certified music therapist (MT-BC) 30-min 2x/week for 4 weeks (8 sessions total); follows the Clinical Practice Model, which guides customizations of various music experiences (e.g., singing, songwriting, movement, relaxation, lyric discussion, improvisation, instrument play, etc.) per participants' strengths, interests, preferences, culture, and momentary responses. Each participant works with the same MT-BC throughout the study. | Behavioural | Collaborative, Non-Collaborative |
| Non-Collaborative Social Work TelehealthAlso: Independent social work intervention, independent wellness supportSocial Work: delivered via Zoom by a licensed social worker (SW) or supervised SW graduate student 3x for 30-min: 1) after 2 weeks MT (assessment), 2) after 4 weeks MT (service referral), 3) 2-week follow-up. SWs operate independently from MT-BCs to identify possible participant service referral needs using the Aging and Memory Quality of Life Survey (AMQoL), baseline data, SW session interactions, and SW Referral Worksheet. Each participant works with the same SW throughout the study. | Behavioural | Non-Collaborative |
| Collaborative Social Work TelehealthAlso: Integrative social work intervention, integrative wellness supportSocial Work: delivered via Zoom by a licensed SW or supervised SW graduate student 3x for 30-min: 1) after 2 weeks MT (assessment), 2) after 4 weeks MT (service referral), 3) 2-week follow-up. In addition to the AMQoL, baseline data, SW session interactions, and the SW Referral Worksheet, SWs collaborate fully with MT-BCs, have full access MT session notes, and can discuss participants' needs with MT-BC to identify possible participant service referral needs. Each participant works with the same SW throughout the study. | Behavioural | Collaborative |
Primary outcome
Mean Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index at 6 Weeks
Time frame: Enrollment, end of Week 6.
A simple 5-item measure of subjective well-being (a combination of feeling good and functioning well). The participant rates each item on a 6-point scale from 0 (at no time) to 5 (all of the time); total raw score ranges from 0 (worst possible) to 25 (best possible well-being); percentage score (raw X 4) ranges from 0 (worst possible) to 100 (best possible well-being). Administered by outcome assessor by phone or Zoom at participant's preference.
Mean Change from Baseline in WHO-5 Well-Being Index at 8 Weeks
Time frame: Enrollment, end of Week 8.
A simple 5-item measure of subjective well-being (a combination of feeling good and functioning well). The participant rates each item on a 6-point scale from 0 (at no time) to 5 (all of the time); total raw score ranges from 0 (worst possible) to 25 (best possible well-being); percentage score (raw X 4) ranges from 0 (worst possible) to 100 (best possible well-being). Administered by outcome assessor by phone or Zoom at participant's preference.
9 secondary outcomes
Mean Change in Self-Reported Feelings for Participants with Dementia
Time frame: Immediately before and immediately after each music therapy session.
Mean Change in Self-Reported Feelings for Participants without Dementia
Time frame: Immediately before and immediately after each music therapy session.
Mean Change from Baseline in University of California, Los Angeles (UCLA) Loneliness Scale at 6 Weeks
Time frame: Enrollment, end of Week 6.
Mean Change from Baseline in UCLA Loneliness Scale at 8 Weeks
Time frame: Enrollment, end of Week 8.
Mean Change from Baseline in Montreal Cognitive Assessment (MoCA) at 6 Weeks
Time frame: Enrollment, end of Week 6.
Program Evaluation Total Score
Time frame: Within 1 week of final social work session.
Program Evaluation Quality Score
Time frame: Within 1 week of final social work session.
Program Evaluation Willingness Score
Time frame: Within 1 week of final social work session.
Program Evaluation Helpfulness Score
Time frame: Within 1 week of final social work session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 32744593Lam K, Lu AD, Shi Y, Covinsky KE. Assessing Telemedicine Unreadiness Among Older Adults in the United States During the COVID-19 Pandemic. JAMA Intern Med. 2020 Oct 1;180(10):1389-1391. doi: 10.1001/jamainternmed.2020.2671.
- Background: PubMed 26501530Kistin C, Silverstein M. Pilot Studies: A Critical but Potentially Misused Component of Interventional Research. JAMA. 2015 Oct 20;314(15):1561-2. doi: 10.1001/jama.2015.10962. No abstract available.
- Background: PubMed 32500841Gibson A, Bardach SH, Pope ND. COVID-19 and the Digital Divide: Will Social Workers Help Bridge the Gap? J Gerontol Soc Work. 2020 Aug-Oct;63(6-7):671-673. doi: 10.1080/01634372.2020.1772438. Epub 2020 Jun 5. No abstract available.
- Background: PubMed 34994028Ng BP, Park C, Silverman CL, Eckhoff DO, Guest JC, Diaz DA. Accessibility and utilisation of telehealth services among older adults during COVID-19 pandemic in the United States. Health Soc Care Community. 2022 Sep;30(5):e2657-e2669. doi: 10.1111/hsc.13709. Epub 2022 Jan 6.
- BackgroundReschke-Hernández, A. E. (2019). A clinical practice model of music therapy to address psychosocial functioning for persons with dementia: Model development and randomized clinical crossover trial (NCT03643003). Doctoral dissertation, University of Iowa. https://doi.org/10.17077/etd.59oh-y06y
- BackgroundReschke-Hernández, A. E. (2021). The Clinical Practice Model for Persons with Dementia: Application to music therapy. Music Therapy Perspectives, 39(2), 133-141. https://doi.org/10.1093/mtp/miab006
- BackgroundReschke-Hernández, A. E., Gibson, A., Buckner, L. E., Sullivan, A. C., Posey, C., & Uecker, S. (2023). Development of a collaborative music therapy and social work telehealth framework to address the well-being of community-dwelling older adults. Research poster presented at: Alzheimer's Association International Conference, Amsterdam, Netherlands, 16-20 July 2023.
- BackgroundWilhelm, L., & Wilhelm, K. (2022). Telehealth music therapy services in the United States with older adults: A descriptive study. Music Therapy Perspectives. Advance online publication. https://doi.org/10.1093/mtp/miab028
- BackgroundWorld Health Organization. (2017, December 7). Global action plan on the public health response to dementia 2017-2025. https://tinyurl.com/bdhm6wha
- BackgroundWorld Health Organization. (2010, September 1). Framework for action on interprofessional education and collaborative practice (WHO Reference Number WHO/HRH/HPN/10.3). https://tinyurl.com/28ykjrn3
- Individual participant dataSharing planned: Yes. This is a small pilot study. Pilot data for preliminary effect size estimating will not be publicly shared. Researchers may request de-identified data and study materials from the principal investigator.
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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. This study is not recruiting at the moment.
Alaine E Reschke-Hernandez, PhD principal investigator
University of Kentucky
Allison Gibson, PhD principal investigator
St. Louis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy Telehealth, Non-Collaborative Social Work Telehealth and Collaborative Social Work Telehealth in people with Aging Well and Dementia, run by Alaine E Hernandez, PhD at 2 sites 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index at 6 Weeks (time frame: Enrollment, end of Week 6.). 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?
On the ClinicalTrials.gov record for NCT06219148, which also lists 10 linked publications.
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 3 Sep 2025.