Music Therapy for Persons With Dementia
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 10/7/2018 |
| Start Date: | May 25, 2018 |
| End Date: | September 30, 2018 |
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.
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.
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.
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.
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)
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