Clinical trial NCT05508646: Group-Based Telehealth Music Therapy Intervention for Patients With Dementia: A Pilot Study
Official title: Group-Based Telehealth Music Therapy Intervention for Patients With Dementia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral and Psychiatric Symptoms of Dementia
Alzheimer Disease
Lewy Body Disease
Frontotemporal Dementia
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini Mental State Examination
timeFrame: 1 year
measure: Geriatric Depression Scale
timeFrame: 1 year
measure: Neuropsychiatric Inventory-Severity/Distress scales
timeFrame: 1 year
measure: Modified Caregiver Strain Index
timeFrame: 1 year
measure: Patient Health Questionnaire-9
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Maya Lichtenstein
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Maya Lichtenstein, MD
role: PRINCIPAL_INVESTIGATOR
References: