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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508646
• Other study ID #: 2021-0409
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: January 2024
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 29, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Behavioral and Psychiatric Symptoms of Dementia
• Dementia
• Frontotemporal Dementia
• Lewy Body Disease
• Pick Disease of the Brain

Intervention

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

Locations

Country	Name	City	State
United States	Maya Lichtenstein	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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).	1 year
Primary	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.	1 year
Primary	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.	1 year