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Quality of LifeNCT03643003

Music Therapy for Persons With Dementia

A study testing Music therapy in people with Quality of Life and Social Interaction, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Quality of Life, Social Interaction, Emotions
What is being tested?
Music therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
25 May 2018to 30 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: 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.

Read the 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).
  1. 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).
  1. 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.
  2. 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.
  1. 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.
  2. "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.
  3. Week 1, UT (baseline; AD-RD Mood Scale, QUALIDEM).
  4. 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)
  5. Weeks 4-5, UT (washout/return to baseline; AD-RD Mood Scale, QUALIDEM).
  6. 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)
  7. Week 8, UT (return to baseline; AD-RD Mood Scale, QUALIDEM).
  8. 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.
Being tested
Music therapy, Non-Music Verbal Interaction (Placebo)
Keywords
music, music therapy
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music therapyBehavioural

    "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.

  • Non-Music Verbal Interaction (Placebo)Behavioural

    "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.

Study groups in NCT03643003
Study groupRoleWhat they receive
Music TherapyExperimental"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.
Receives: Behavioral: Music therapy; Behavioral: Non-Music Verbal Interaction (Placebo)
Non-Music Verbal InteractionPlacebo comparator"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.
Receives: Behavioral: Music therapy; Behavioral: Non-Music Verbal Interaction (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Engagement Behavior Score

    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.

    Measured: Week 8

  2. Emotion Behavior Score

    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).

    Measured: Week 8

  3. Mood Behavior Score

    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).

    Measured: Week 8

  4. Self-Reported Feelings Score

    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.

    Measured: Week 8

  5. Quality of Life Behavior Score

    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.

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start25 May 2018
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will engage in a music therapy condition of interest, and a non-music, verbal discussion comparison condition. The order is randomly assigned and counterbalanced across nursing homes, and all participants complete both conditions.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03643003
Sponsor's protocol ID
201709731
Status last verified
Feb 2023
First submitted
20 Aug 2018
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cohen-Mansfield J, Dakheel-Ali M, Marx MS. Engagement in persons with dementia: the concept and its measurement. Am J Geriatr Psychiatry. 2009 Apr;17(4):299-307. doi: 10.1097/JGP.0b013e31818f3a52.

    PubMed 19307858

  • Cohen-Mansfield J, Marx MS, Freedman LS, Murad H, Regier NG, Thein K, Dakheel-Ali M. The comprehensive process model of engagement. Am J Geriatr Psychiatry. 2011 Oct;19(10):859-70. doi: 10.1097/JGP.0b013e318202bf5b.

    PubMed 21946802

  • Feinstein JS, Duff MC, Tranel D. Sustained experience of emotion after loss of memory in patients with amnesia. Proc Natl Acad Sci U S A. 2010 Apr 27;107(17):7674-9. doi: 10.1073/pnas.0914054107. Epub 2010 Apr 12.

    PubMed 20385824

  • Ferguson SH, Quene H. Acoustic correlates of vowel intelligibility in clear and conversational speech for young normal-hearing and elderly hearing-impaired listeners. J Acoust Soc Am. 2014 Jun;135(6):3570-84. doi: 10.1121/1.4874596.

    PubMed 24907820

  • Hebert LE, Weuve J, Scherr PA, Evans DA. Alzheimer disease in the United States (2010-2050) estimated using the 2010 census. Neurology. 2013 May 7;80(19):1778-83. doi: 10.1212/WNL.0b013e31828726f5. Epub 2013 Feb 6.

    PubMed 23390181

  • Janata P. The neural architecture of music-evoked autobiographical memories. Cereb Cortex. 2009 Nov;19(11):2579-94. doi: 10.1093/cercor/bhp008. Epub 2009 Feb 24.

    PubMed 19240137

  • Keeler JR, Roth EA, Neuser BL, Spitsbergen JM, Waters DJ, Vianney JM. The neurochemistry and social flow of singing: bonding and oxytocin. Front Hum Neurosci. 2015 Sep 23;9:518. doi: 10.3389/fnhum.2015.00518. eCollection 2015.

    PubMed 26441614

  • Koelsch S. Toward a neural basis of music perception - a review and updated model. Front Psychol. 2011 Jun 9;2:110. doi: 10.3389/fpsyg.2011.00110. eCollection 2011.

    PubMed 21713060

  • Kolanowski A, Litaker M, Buettner L, Moeller J, Costa PT Jr. A randomized clinical trial of theory-based activities for the behavioral symptoms of dementia in nursing home residents. J Am Geriatr Soc. 2011 Jun;59(6):1032-41. doi: 10.1111/j.1532-5415.2011.03449.x. Epub 2011 Jun 7.

    PubMed 21649633

  • Kverno KS, Black BS, Nolan MT, Rabins PV. Research on treating neuropsychiatric symptoms of advanced dementia with non-pharmacological strategies, 1998-2008: a systematic literature review. Int Psychogeriatr. 2009 Oct;21(5):825-43. doi: 10.1017/S1041610209990196. Epub 2009 Jul 9.

    PubMed 19586562

  • Livingston G, Kelly L, Lewis-Holmes E, Baio G, Morris S, Patel N, Omar RZ, Katona C, Cooper C. A systematic review of the clinical effectiveness and cost-effectiveness of sensory, psychological and behavioural interventions for managing agitation in older adults with dementia. Health Technol Assess. 2014 Jun;18(39):1-226, v-vi. doi: 10.3310/hta18390.

    PubMed 24947468

  • McDermott O, Orrell M, Ridder HM. The importance of music for people with dementia: the perspectives of people with dementia, family carers, staff and music therapists. Aging Ment Health. 2014;18(6):706-16. doi: 10.1080/13607863.2013.875124. Epub 2014 Jan 13.

    PubMed 24410398

  • Millan-Calenti JC, Lorenzo-Lopez L, Alonso-Bua B, de Labra C, Gonzalez-Abraldes I, Maseda A. Optimal nonpharmacological management of agitation in Alzheimer's disease: challenges and solutions. Clin Interv Aging. 2016 Feb 22;11:175-84. doi: 10.2147/CIA.S69484. eCollection 2016.

    PubMed 26955265

  • Muller V, Lindenberger U. Cardiac and respiratory patterns synchronize between persons during choir singing. PLoS One. 2011;6(9):e24893. doi: 10.1371/journal.pone.0024893. Epub 2011 Sep 21.

    PubMed 21957466

  • Osman SE, Tischler V, Schneider J. 'Singing for the Brain': A qualitative study exploring the health and well-being benefits of singing for people with dementia and their carers. Dementia (London). 2016 Nov;15(6):1326-1339. doi: 10.1177/1471301214556291. Epub 2014 Nov 24.

    PubMed 25425445

Questions about this trial

What is this clinical trial studying?

A study testing Music therapy in people with Quality of Life and Social Interaction, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Engagement Behavior Score (time frame: Week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03643003, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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Music Therapy for Persons With Dementia (NCT03643003) | AzTrials