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

NCT05508646 | Completed

• 1 other identifier: 2021-0409
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral and Psychiatric Symptoms of Dementia; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention arm

EXPERIMENTAL

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.

Behavioral: Music therapy intervention

Control arm

OTHER

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

Interventions

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.

Intervention arm

Personalized music CD BEHAVIORAL

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

Control arm

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Maya Lichtenstein

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

Behavior; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maya Lichtenstein, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 19, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 29, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)