Behavioral and Psychiatric Symptoms of DementiaNCT05508646
Group-Based Telehealth Music Therapy Intervention for Patients With Dementia: A Pilot Study
A study testing Music therapy intervention and Personalized music CD in people with Behavioral and Psychiatric Symptoms of Dementia and Alzheimer Disease, run by Geisinger Clinic at 1 site in United States.
Trial summary
Twelve participants and their care partners will be randomized for the intervention. The music therapy intervention takes place once a week for 6 weeks via telemedicine, with the first session reserved for music therapy intake/assessment. There are 5 additional visits, once per week. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Behavioral and Psychiatric Symptoms of Dementia, Alzheimer Disease, Lewy Body Disease
- What is being tested?
- Music therapy intervention and Personalized music CD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 29 Jan 2024
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate dementia (MMSE 13-26 at their last clinic visit, if within 6 months)
- English-speaking
- Auditory acuity adequate for participating with music therapy
- Access to high-speed internet, webcam, and a microphone
- A caregiver willing to participate
- Must be an adult relative, friend, or caretaker (non-professional)
- English speaking
- Visual and auditory acuity adequate for communicating with examiner and completing questionnaires
Who cannot join
- Must not be presently participating in another interventional study
- Must not demonstrate increased anxiety/distress when utilizing a telehealth platform
- Must not have received a clinical prognosis of rapidly progressing dementia
Trial locations and contacts
1 site in 1 country.
About this study
Twelve participants and their care partners will be randomized for the intervention. The music therapy intervention takes place once a week for 6 weeks via telemedicine, with the first session reserved for music therapy intake/assessment. There are 5 additional visits, once per week. The format of the sessions may include: a greeting song to orient the participant to the start of the session; singing of 1-3 preferred/chosen songs to address cognition and communication; two movement songs with instrument playing interventions to stimulate cognition and movement; songwriting for self-expression, cognitive, and emotional support; relaxation/mindfulness; a closing song to help the participant transition at the completion of the session, The music therapist also provides training to caregivers in techniques to utilize music for behavioral support.
Twelve participants and their care partners will be randomized to receive a personalized music CD that they keep and can listen to as they wish.
Read the detailed description
This is a single-blinded prospective randomized control pilot study. We are aiming to recruit 24 participants, with their caregiver, who have mild to moderate dementia from Geisinger Memory and Cognition Program. 12 participants will be randomized for the music intervention arm, and 12 for the control arm. The music therapy intervention takes place once a week for 6 weeks via telemedicine. 12 participants will be randomized to receive a music CD with a personalized playlist. At baseline and end of study several measures will be completed: Mini-mental State Examination and the Geriatric Depression Scale by the participant; and the caregiver will complete the Neuropsychiatric Inventory-Severity/Distress scales, Modified Caregiver Stain Index and Patient Health Questionnaire-9 at those times as well as at 6 weeks. The music therapist will fill out an engagement form for each session she has with the participant. The primary outcome is to compare pre- and post-scores on measures of cognition, BPSD, caregiver strain, and depression for participant and caregiver for those undergoing the telehealth music therapy intervention vs. those who receive a personalized music selection on CD. We also aim to explore whether degree of engagement during music therapy affects outcomes in Aim 1.
With significant economic and emotional impacts, caregiving for patients with dementia is stressful. BPSD associated with dementia leads to increased stress for people with dementia and their loved ones and may lead to earlier nursing home placement. If behavioral symptoms of persons with dementia could be alleviated, caregivers may feel more empowered, and patients with dementia may be able to stay at home longer. Music therapy has been shown to help with behaviors, agitation, and depression, and may help decrease caregiver stress. We are hoping through this study to show that using a telehealth platform, music therapy is feasible for patients who would not otherwise have access to it.
- Conditions
- Behavioral and Psychiatric Symptoms of Dementia, Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia
- Being tested
- Music therapy intervention, Personalized music CD
- Medical subject headings
- Behavior, Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy interventionBehavioural
The format of the sessions may include: a greeting song to orient the participant to the start of the session; singing of 1-3 preferred/chosen songs to address cognition and communication; two movement songs with instrument playing interventions to stimulate cognition and movement; songwriting for self-expression, cognitive, and emotional support; relaxation/mindfulness; a closing song to help the participant transition at the completion of the session, The music therapist also provides training to caregivers in techniques to utilize music for behavioral support.
Personalized music CDBehavioural
Participants will receive a personalized music CD that they keep and can listen to as they wish.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Twelve participants will be randomized for the intervention. The music therapy intervention takes place once a week for 6 weeks via telemedicine, with the first session reserved for music therapy intake/assessment. There are 5 additional visits, once per week. The format of the sessions may include: a greeting song to orient the participant to the start of the session; singing of 1-3 preferred/chosen songs to address cognition and communication; two movement songs with instrument playing interventions to stimulate cognition and movement; songwriting for self-expression, cognitive, and emotional support; relaxation/mindfulness; a closing song to help the participant transition at the completion of the session, The music therapist also provides training to caregivers in techniques to utilize music for behavioral support. Receives: Behavioral: Music therapy intervention |
| Control arm | Other | Twelve participants will be randomized to receive a personalized music CD that they keep and can listen to as they wish. Receives: Behavioral: Personalized music CD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination
The Mini Mental State Examination is a 30-point questionnaire used to measure cognitive impairment. Any score of 24 or more indicates a normal cognition. Scores of ≤9 points can indicate severe, 10-18 points moderate or 19-23 points mild cognitive impairment.
Measured: 1 year
Geriatric Depression Scale
The Geriatric Depression Scale is a 30-item questionnaire used to measure depression in older populations. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Measured: 1 year
Neuropsychiatric Inventory-Severity/Distress scales
The Neuropsychiatric Inventory-Severity/Distress scales are used to determine the severity of the participants' neuropsychiatric symptoms and the distress these cause the caregiver. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress).
Measured: 1 year
Modified Caregiver Strain Index
The Modified Caregiver Strain Index uses 13 questions to measure strain related to caregiving. Scoring ranges from 26 to 0. Each 'yes' equals 2 points, each 'sometimes' equals 1 point, and each 'no' equals 0 points. A higher score indicates a higher level of caregiver strain.
Measured: 1 year
Patient Health Questionnaire-9
Patient Health Questionnaire-9 uses 9 questions to measure the caregivers' symptoms of depression. Scoring ranges from 27 to 0. Scores ranging from 0 to 4 points are considered normal/minimal. Scores ranging from 5 to 9 points are considered mild depression severity. Scores ranging from 10 to 14 points are considered moderate depression severity. Scores ranging from 15 to 19 points are considered moderately severe depression severity. Scores ranging from 20 to 27 points are considered severe depression severity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral and Psychiatric Symptoms of DementiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maya Lichtenstein, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508646
- Sponsor's protocol ID
- 2021-0409
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2022
- Last updated
- 30 Jan 2024
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-Based Telehealth Music Therapy Intervention for Patients With Dementia: A Pilot Study
- ClinicalTrials.gov ID
- NCT05508646
- Acronym / sponsor ID
- 2021-0409
- Conditions
- Behavioral and Psychiatric Symptoms of Dementia, Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 19 Aug 2022 (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.
Twelve participants and their care partners will be randomized for the intervention. The music therapy intervention takes place once a week for 6 weeks via telemedicine, with the first session reserved for music therapy intake/assessment. There are 5 additional visits, once per week. The format of the sessions may include: a greeting song to orient the participant to the start of the session; singing of 1-3 preferred/chosen songs to address cognition and communication; two movement songs with instrument playing interventions to stimulate cognition and movement; songwriting for self-expression, cognitive, and emotional support; relaxation/mindfulness; a closing song to help the participant transition at the completion of the session, The music therapist also provides training to caregivers in techniques to utilize music for behavioral support.
Twelve participants and their care partners will be randomized to receive a personalized music CD that they keep and can listen to as they wish.
Detailed description
This is a single-blinded prospective randomized control pilot study. We are aiming to recruit 24 participants, with their caregiver, who have mild to moderate dementia from Geisinger Memory and Cognition Program. 12 participants will be randomized for the music intervention arm, and 12 for the control arm. The music therapy intervention takes place once a week for 6 weeks via telemedicine. 12 participants will be randomized to receive a music CD with a personalized playlist. At baseline and end of study several measures will be completed: Mini-mental State Examination and the Geriatric Depression Scale by the participant; and the caregiver will complete the Neuropsychiatric Inventory-Severity/Distress scales, Modified Caregiver Stain Index and Patient Health Questionnaire-9 at those times as well as at 6 weeks. The music therapist will fill out an engagement form for each session she has with the participant. The primary outcome is to compare pre- and post-scores on measures of cognition, BPSD, caregiver strain, and depression for participant and caregiver for those undergoing the telehealth music therapy intervention vs. those who receive a personalized music selection on CD. We also aim to explore whether degree of engagement during music therapy affects outcomes in Aim 1.
With significant economic and emotional impacts, caregiving for patients with dementia is stressful. BPSD associated with dementia leads to increased stress for people with dementia and their loved ones and may lead to earlier nursing home placement. If behavioral symptoms of persons with dementia could be alleviated, caregivers may feel more empowered, and patients with dementia may be able to stay at home longer. Music therapy has been shown to help with behaviors, agitation, and depression, and may help decrease caregiver stress. We are hoping through this study to show that using a telehealth platform, music therapy is feasible for patients who would not otherwise have access to it.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Music therapy interventionTwelve participants will be randomized for the intervention. The music therapy intervention takes place once a week for 6 weeks via telemedicine, with the first session reserved for music therapy intake/assessment. There are 5 additional visits, once per week. The format of the sessions may include: a greeting song to orient the participant to the start of the session; singing of 1-3 preferred/chosen songs to address cognition and communication; two movement songs with instrument playing interventions to stimulate cognition and movement; songwriting for self-expression, cognitive, and emotional support; relaxation/mindfulness; a closing song to help the participant transition at the completion of the session, The music therapist also provides training to caregivers in techniques to utilize music for behavioral support. |
| Control arm | Other | Behavioral: Personalized music CDTwelve participants will be randomized to receive a personalized music CD that they keep and can listen to as they wish. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mild to moderate dementia (MMSE 13-26 at their last clinic visit, if within 6 months)
- English-speaking
- Auditory acuity adequate for participating with music therapy
- Access to high-speed internet, webcam, and a microphone
- A caregiver willing to participate
Key exclusion criteria (3 listed)
- Must not be presently participating in another interventional study
- Must not demonstrate increased anxiety/distress when utilizing a telehealth platform
- Must not have received a clinical prognosis of rapidly progressing dementia
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 interventionThe format of the sessions may include: a greeting song to orient the participant to the start of the session; singing of 1-3 preferred/chosen songs to address cognition and communication; two movement songs with instrument playing interventions to stimulate cognition and movement; songwriting for self-expression, cognitive, and emotional support; relaxation/mindfulness; a closing song to help the participant transition at the completion of the session, The music therapist also provides training to caregivers in techniques to utilize music for behavioral support. | Behavioural | Intervention arm |
| Personalized music CDParticipants will receive a personalized music CD that they keep and can listen to as they wish. | Behavioural | Control arm |
Primary outcome
Mini Mental State Examination
Time frame: 1 year
The Mini Mental State Examination is a 30-point questionnaire used to measure cognitive impairment. Any score of 24 or more indicates a normal cognition. Scores of ≤9 points can indicate severe, 10-18 points moderate or 19-23 points mild cognitive impairment.
Geriatric Depression Scale
Time frame: 1 year
The Geriatric Depression Scale is a 30-item questionnaire used to measure depression in older populations. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Neuropsychiatric Inventory-Severity/Distress scales
Time frame: 1 year
The Neuropsychiatric Inventory-Severity/Distress scales are used to determine the severity of the participants' neuropsychiatric symptoms and the distress these cause the caregiver. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 1=minimal distress; 2=mild distress; 3=moderate distress; 4=severe distress; and 5=extreme distress).
Modified Caregiver Strain Index
Time frame: 1 year
The Modified Caregiver Strain Index uses 13 questions to measure strain related to caregiving. Scoring ranges from 26 to 0. Each 'yes' equals 2 points, each 'sometimes' equals 1 point, and each 'no' equals 0 points. A higher score indicates a higher level of caregiver strain.
Patient Health Questionnaire-9
Time frame: 1 year
Patient Health Questionnaire-9 uses 9 questions to measure the caregivers' symptoms of depression. Scoring ranges from 27 to 0. Scores ranging from 0 to 4 points are considered normal/minimal. Scores ranging from 5 to 9 points are considered mild depression severity. Scores ranging from 10 to 14 points are considered moderate depression severity. Scores ranging from 15 to 19 points are considered moderately severe depression severity. Scores ranging from 20 to 27 points are considered severe depression severity.
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 30 Jan 2024.
- 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. This study is not recruiting at the moment.
Maya Lichtenstein, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy intervention and Personalized music CD in people with Behavioral and Psychiatric Symptoms of Dementia and Alzheimer Disease, run by Geisinger Clinic 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 8 inclusion and 3 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 30 Jan 2024. 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. 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?
Mini Mental State Examination (time frame: 1 year). The study lists 5 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 30 Jan 2024.