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Completed

NCT Number: NCT05508646

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

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Key information

Conditions

Behavioral and Psychiatric Symptoms of Dementia Alzheimer Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Dementia Frontotemporal Dementia Frontotemporal Lobar Degeneration Lewy Body Disease Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinsonian Disorders Proteostasis Deficiencies Synucleinopathies TDP-43 Proteinopathies Tauopathies

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maya Lichtenstein

Wilkes-Barre, Pennsylvania, 18702, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy Intervention

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.

Personalized music CD

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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