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

NCT ID: NCT05508646

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-01-29

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention arm

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.

Group Type: EXPERIMENTAL

Music therapy intervention

Intervention Type: BEHAVIORAL

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

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

Group Type: OTHER

Personalized music CD

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Personalized music CD

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maya Lichtenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Maya Lichtenstein

Wilkes-Barre, Pennsylvania, United States

Countries

United States

Other Identifiers

2021-0409

Identifier Type: -

Identifier Source: org_study_id