Music Therapy for Persons With Dementia

NCT03643003 | Completed

• 1 other identifier: 201709731
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Quality of Life; Social Interaction; Emotions; Mood; Feelings; Alzheimer Disease; Dementia

Keywords

music; music therapy

Outcome Measures

Primary Outcomes (5)

• 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.

  Week 8

• 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).

  Week 8

• 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).

  Week 8

• 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.

  Week 8

• 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.

  Week 8

Study Arms (2)

Music Therapy

EXPERIMENTAL

"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; Behavioral: Non-Music Verbal Interaction (Placebo)

Non-Music Verbal Interaction

PLACEBO 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.

Behavioral: Music therapy; Behavioral: Non-Music Verbal Interaction (Placebo)

Interventions

Music therapy BEHAVIORAL

"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.

Music Therapy; Non-Music Verbal Interaction

Non-Music Verbal Interaction (Placebo) BEHAVIORAL

"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.

Music Therapy; Non-Music Verbal Interaction

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (35)

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Related Links

• Alzheimer's Association
• American Music Therapy Association

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alaine Reschke-Hernandez, MA

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: May 25, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)