Group-Based Telehealth Music Therapy Intervention for Patients With Dementia: A Pilot Study

Sponsor

Geisinger Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05508646

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Twelve participants and their care partners will be randomized for the intervention. The music therapy intervention takes place once a week for 12 weeks via telemedicine, with the first session reserved for music therapy intake/assessment. There are 11 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.

Condition or Disease	Intervention/Treatment	Phase
Behavioral and Psychiatric Symptoms of Dementia Alzheimer Disease Lewy Body Disease Frontotemporal Dementia	Behavioral: Music therapy intervention Behavioral: Personalized music CD	N/A

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 12 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

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Group-Based Telehealth Music Therapy Intervention for Patients With Dementia: A Pilot Study

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm Twelve participants will be randomized for the intervention. The music therapy intervention takes place once a week for 12 weeks via telemedicine, with the first session reserved for music therapy intake/assessment. There are 11 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.	Behavioral: Music therapy intervention 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.
Other: Control arm Twelve participants will be randomized to receive a personalized music CD that they keep and can listen to as they wish.	Behavioral: Personalized music CD Participants will receive a personalized music CD that they keep and can listen to as they wish.

Arm

Intervention/Treatment

Experimental: Intervention arm

Twelve participants will be randomized for the intervention. The music therapy intervention takes place once a week for 12 weeks via telemedicine, with the first session reserved for music therapy intake/assessment. There are 11 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.

Behavioral: Music therapy intervention

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.

Other: Control arm

Twelve participants will be randomized to receive a personalized music CD that they keep and can listen to as they wish.

Behavioral: Personalized music CD

Participants will receive a personalized music CD that they keep and can listen to as they wish.

Outcome Measures

Primary Outcome Measures

Mini Mental State Examination [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inclusion criteria for participants:

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

Inclusion Criteria for Caregivers:

Must be an adult relative, friend, or caretaker (non-professional)
English speaking
Visual and auditory acuity adequate for communicating with examiner and completing questionnaires

Exclusion Criteria:

Exclusion Criteria for participants:

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