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

Primary Purpose

Behavioral and Psychiatric Symptoms of Dementia, Alzheimer Disease, Lewy Body Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music therapy intervention
Personalized music CD
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Behavioral and Psychiatric Symptoms of Dementia

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maya LichtensteinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention arm

Control arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2022
Last Updated
February 6, 2023
Sponsor
Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05508646
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral and Psychiatric Symptoms of Dementia, Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Other
Arm Description
Twelve participants will be randomized to receive a personalized music CD that they keep and can listen to as they wish.
Intervention Type
Behavioral
Intervention Name(s)
Music therapy intervention
Intervention Description
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
Intervention Name(s)
Personalized music CD
Intervention Description
Participants will receive a personalized music CD that they keep and can listen to as they wish.
Primary Outcome Measure Information:
Title
Mini Mental State Examination
Description
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.
Time Frame
1 year
Title
Geriatric Depression Scale
Description
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.
Time Frame
1 year
Title
Neuropsychiatric Inventory-Severity/Distress scales
Description
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).
Time Frame
1 year
Title
Modified Caregiver Strain Index
Description
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.
Time Frame
1 year
Title
Patient Health Questionnaire-9
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chelsie M Derr
Phone
(570)214-2432
Email
cmderr1@geisinger.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Hooper
Phone
(570)214-3324
Email
nhooper1@geisinger.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Lichtenstein, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maya Lichtenstein
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Hooper
Phone
570-214-3324
Email
nhooper1@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Chelsie Derr
Phone
5702142432
Email
cmderr1@geisinger.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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