Music Therapy for Persons With Dementia

February 13, 2023 updated by: University of Iowa

Music Therapy for Persons With Dementia: A Randomized Clinical Crossover Trial

The purpose of this study is to examine the effectiveness of a specific, protocol-based group music therapy intervention, relative to a verbal discussion activity. The study will examine the impact of the specified music therapy intervention on: (1) affective outcomes, (2) social engagement behaviors, and (3) observed quality of life of persons with ADRD. This study will use a within-subjects randomized crossover design involving N=30 persons with ADRD from nursing homes to examine two levels of independent variable: singing-based music therapy and verbal discussion. Both conditions will be held in small groups of 3-6 participants. Nursing homes will be randomly assigned to an intervention sequence in a counterbalanced order (either music therapy first or verbal discussion first), and participants serve as their own controls. Each condition will occur three times per week for two consecutive weeks (6 sessions per treatment). Each session lasts for 25 minutes in the afternoon. A 2-week "wash-out" period (i.e., usual treatment) will occur between conditions. Participants will remain with their assigned small group for all study activities (i.e., music therapy, verbal discussion). Board-certified music therapists (i.e., MT-BC) will lead both conditions and will complete systematic training to ensure these conditions are implemented as intended, following a manualized protocol. An independent auditor will conduct random checks to ensure the music therapists are implementing the conditions as stipulated in the protocol. Data takers will complete systematic, manualized training to ensure reliable data collection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Following the consent process, the PI will collect demographics, music background, and preference information from participants' family and/or facility care staff. Where possible, the PI will ask participants directly about their music preferences.
  2. The main study period will last 9 weeks and will consist of the following: (a) a "pre-study" week involving a practice session that includes aspects of both study conditions. All study personnel, and facility staff, will gain practice running through study procedures; (1) one week of usual treatment (UT) to collect baseline mood and quality of life data; (2-3) random assignment to two weeks of either music therapy or the verbal discussion; (4-5) a two-week washout period for collecting mood and quality of life data during return to UT; (6-7) crossover to the other condition; and (8) one final week return to UT with mood and quality of life data collection.

  3. The PI will collect descriptive information during the pre-study week and first week of UT using the following measures (previously validated with this population):

    • Clinical Dementia Rating (CDR; Morris, 1993), consists of semi-structured interviews with the patient and an informant by a trained rater (in this case, the PI) regarding memory, orientation, judgment and problem solving, community affairs, hobbies, and personal care. Provides information depth. Scores range from 0 ("normal") to 3 (severe dementia).
    • Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005), a brief screening of cognitive function. Scores range from 0 (greatly impaired) to 30 (unimpaired). Provides a quick assessment of cognitive functioning.
    • Charlson Age-Comorbidity Index (CACI; Charlson et al., 1987), compares the severity of International Classification of Diseases diagnosis codes and provides a systematic way to quantify general health in clinical research, via chart review. Scores range from 0 (excellent health) to 37 (poor health).
    • Katz Index of Independence in Activities of Daily Living (Katz Index; Katz et al., 1970), a brief measure of basic daily functional activities. Scores range from 0 (total dependence) to 6 (independent).

  4. Weekly measures (administered to facility care staff by data takers, or via REDCap, at the end of each of the 9 weeks of the study):

    • REDCap is a data management tool that provides a secure, reliable web-based interface for collecting, managing, and storing study information.
    • AD-RD Mood Scale: a proxy measure of mood (Tappen & Williams, 2008) that yields a positive mood total score with two subscores (spirited, contented) and a negative mood total score with three subscores (hostile, apathetic, sad).
    • QUALIDEM: a multidimensional proxy measure of quality of life that examines person-environment quality of life indicators that are specific to persons with ADRD (Ettema, 2007; Ettema at al., 2005).
  5. Activity Involvement Checklist: A data taker will ask the activity directors at participating facilities to complete the Activity Checklist regarding the types of activities offered to participants in a typical week, and whether or not participants tend to join in these activities. Note that this tool will only be used once. The facility may also opt to complete this questionnaire electronically via REDCap.

  6. Session measures, all administered by trained data takers during participation in either music therapy or verbal discussion:

    • Dementia Mood Picture Test (DMPT; Tappen & Barry, 1995), a 6-item self-report measure of participants' feelings using simple face drawings and verbal descriptors. Yields a single score that ranges from 0 (most negative mood) to 12 (most positive mood). Administered before and after each session.
    • Menorah Park Engagement Scale (MPES; Camp et al., 2015), an observational measure of social engagement and activity. Yields a profile of six engagement scores, averaged across 5-minute observation intervals. The MPES incorporate items from the Observed Emotion Rating Scale (OERS; Lawton et al., 1996; 1999), an observational measure of facial expressions that indicate basic emotions.
  7. Session protocol (music therapy, verbal discussion): grounded in a conceptual framework based in extant literature regarding how the intervention is expected to influence affective, social, and quality of life outcomes. This framework consists of intervention strategies organized within 6 themes: cognition, attention, familiarity, audibility, structure, and autonomy. The music therapy condition consists of live singing with guitar accompaniment by a board-certified music therapist (i.e., MT-BC) using participant-preferred selections. The conceptual framework and accompanying strategies inform how the music is manipulated in real time by the music therapist to meet participants' momentary needs and demonstration of strengths. The verbal condition is designed as a non-music comparison using all of the same strategies and adaptations, but in a non-music context. It consists of live conversation led by an MT-BC using conversation starters centered around age-appropriate, familiar topics. For both condition, sessions will be centered around a main topic (Travel/Places, Nature/Hobbies, & Love/Friendship), each of which will be used in two consecutive sessions in the same order across all participants. Sessions will occur three times per week for two consecutive weeks (6 sessions per treatment). Each session lasts for 25 minutes in the afternoon.
  8. "Pre-Study" Week: Practice session (one 30-minute session), the music therapist will practice aspects of both the music therapy protocol and the verbal discussion protocol. Data takers will practice all data collection procedures. Facility staff will gain practice transitioning participants to and from the sessions.
  9. Week 1, UT (baseline; AD-RD Mood Scale, QUALIDEM).
  10. Weeks 2-3, first randomly assigned condition - either music therapy first or verbal discussion first (DMPT pre/post session, MPES+OERS during session; AD-RD Mood Scale and QUALIDEM end-of-week)
  11. Weeks 4-5, UT (washout/return to baseline; AD-RD Mood Scale, QUALIDEM).
  12. Weeks 6-7, crossover to condition not yet received - either music therapy or verbal discussion (DMPT pre/post session, MPES+OERS during session; AD-RD Mood Scale and QUALIDEM end-of-week)
  13. Week 8, UT (return to baseline; AD-RD Mood Scale, QUALIDEM).
  14. Post-study: as a general measure of decline over the course of the study, the PI will re-administer the MoCA. To minimize burden on participants and nursing home staff, the PI will not re-administer any of the other pre-study assessments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Residents of nursing homes in Eastern Iowa
  • Physician's diagnosis (e.g., primary care doctor, neurologist) of Alzheimer's disease (AD) or a related dementia (e.g., vascular)
  • At least 65 years old
  • English is first and primary language
  • Have lived at facility for at least 3 months

Exclusion Criteria:

  • Individuals who currently receive music therapy services from a board-certified music therapist
  • Severe hearing loss that prohibits enjoyment of music
  • Severe vision impairment that precludes seeing enlarged visual aids and font
  • Those identified with "age-related cognitive decline" without a formal diagnosis of AD or a related dementia
  • Individuals receiving hospice services or are bedridden
  • Individuals with young onset AD
  • Individuals with co-occurring Parkinson's disease, Huntington's disease, Down's syndrome, or severe mental illness (e.g., schizophrenia, bipolar disorder, major depressive or major anxiety disorder identified prior to dementia diagnosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Music Therapy
"Music therapy" consists of live singing of participant-preferred music, with guitar accompaniment, by a board-certified music therapist (i.e., MT-BC), following a protocol regarding how to manipulate the music in real time per participant responses. Order is randomly assigned, and all participants engage in both study arms.
Behavioral: Music therapy
"Music therapy" consists of live singing of participant-preferred music, with guitar accompaniment, by a board-certified music therapist (i.e., MT-BC), following a protocol regarding how to manipulate the music in real time per participant responses. Dosage: participants engage in a small-group (3-6 participants) session at their nursing home, 3 times per week, across 2 consecutive weeks. Each session lasts 25 minutes and occurs in the afternoon.
Behavioral: Non-Music Verbal Interaction (Placebo)
"Non-music verbal interaction" consists of conversation of participants' interests, without music, by a board-certified music therapist, following a protocol regarding how to respond verbally in real time per participant responses. Dosage is the same as for music therapy: participants engage in a small-group (3-6 participants) session at their nursing home, 3 times per week, across 2 consecutive weeks. Each session lasts 25 minutes and occurs in the afternoon.
Placebo Comparator: Non-Music Verbal Interaction
"Non-music verbal interaction" consists of conversation of participants' interests, without music, by a board-certified music therapist, following a protocol regarding how to respond verbally in real time per participant responses. Order is randomly assigned, and all participants engage in both study arms.
Behavioral: Music therapy
"Music therapy" consists of live singing of participant-preferred music, with guitar accompaniment, by a board-certified music therapist (i.e., MT-BC), following a protocol regarding how to manipulate the music in real time per participant responses. Dosage: participants engage in a small-group (3-6 participants) session at their nursing home, 3 times per week, across 2 consecutive weeks. Each session lasts 25 minutes and occurs in the afternoon.
Behavioral: Non-Music Verbal Interaction (Placebo)
"Non-music verbal interaction" consists of conversation of participants' interests, without music, by a board-certified music therapist, following a protocol regarding how to respond verbally in real time per participant responses. Dosage is the same as for music therapy: participants engage in a small-group (3-6 participants) session at their nursing home, 3 times per week, across 2 consecutive weeks. Each session lasts 25 minutes and occurs in the afternoon.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Social Engagement Behavior Score
Time Frame: Week 8
Refers to participants' involvement within the social environment, measured measured by trained data takers using the Menorah Park Engagement Scale (MPES; Camp et al., 2015). The MPES was designed for use with dementia patients. According to this scale, there are 5 categories of engagement: constructive, passive, other engagement, non-engagement, and disengagement. These categories are measured via behavioral observation in 5-minute observation intervals. Behaviors are rated: not at all (0), up to half of the observation interval (1 point), or more than half of the observation interval (2 points). The MPES incorporates the Observed Emotion Rating Scale, described in another section.
Week 8
Emotion Behavior Score
Time Frame: Week 8
Refers to participants' displayed facial expressions as an indicator of basic emotions, measured by trained data takers using the Observed Emotion Rating Scale (OERS; Lawton et al., 1996; 1999). The OERS was designed for use with dementia patients. Four of the 5 items on this scale will be used (pleasure, anger, anxiety/fear, depression/sadness; not interest) in 5-minute observation intervals during each session, in conjunction with the Menorah Park Engagement Scale (described in an earlier section).
Week 8
Mood Behavior Score
Time Frame: Week 8
Refers to behavioral indicators of emotion over a longer period of time (i.e., mood), measured using the AD-RD Mood Scale (Tappen & Williams, 2008; designed for use with dementia patients). This proxy measure will be completed weekly by facility care staff who have interacted frequently with participants over the past week. The scale yields a positive mood total score with two subscores (spirited, contented) and a negative mood total score with three subscores (hostile, apathetic, sad).
Week 8
Self-Reported Feelings Score
Time Frame: Week 8
Refers to momentary, self-reported feelings of participants before and after music therapy and verbal discussion sessions. Measured using the Dementia Mood Picture Test (DMPT; Tappen & Barry, 1995), which is a 6-item self-report measure that was designed to use with patients with more severe dementia. It uses simple face drawings and verbal descriptors to facilitate a response. Yields a single score that ranges from 0 (most negative mood) to 12 (most positive mood). Administered before and after each session.
Week 8
Quality of Life Behavior Score
Time Frame: Week 8
Refers to behavioral indicators of quality of life over a week, measured using the QUALIDEM (Ettema, 2007; Ettema at al., 2005; designed for use with dementia patients). This proxy measure will be completed weekly by facility care staff who have interacted frequently with participants over the past week. This measure considers multiple person-environment dimensions of how the individual with dementia interacts with his or her environment, and includes objective environmental and behavioral components, the patient's subjective experience, and how the person functions within the social environment.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201709731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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