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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03643003
Other study ID # 201709731
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2018
Est. completion date September 30, 2018

Study information

Verified date February 2023
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States University of Iowa Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (35)

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Reschke-Hernandez AE, Okerstrom KL, Bowles Edwards A, Tranel D. Sex and stress: Men and women show different cortisol responses to psychological stress induced by the Trier social stress test and the Iowa singing social stress test. J Neurosci Res. 2017 Jan 2;95(1-2):106-114. doi: 10.1002/jnr.23851. — View Citation

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Sakamoto M, Ando H, Tsutou A. Comparing the effects of different individualized music interventions for elderly individuals with severe dementia. Int Psychogeriatr. 2013 May;25(5):775-84. doi: 10.1017/S1041610212002256. Epub 2013 Jan 8. — View Citation

Sarkamo T, Tervaniemi M, Laitinen S, Numminen A, Kurki M, Johnson JK, Rantanen P. Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study. Gerontologist. 2014 Aug;54(4):634-50. doi: 10.1093/geront/gnt100. Epub 2013 Sep 5. — View Citation

Schubert E. Emotion felt by the listener and expressed by the music: literature review and theoretical perspectives. Front Psychol. 2013 Dec 17;4:837. doi: 10.3389/fpsyg.2013.00837. — View Citation

Tappen RM, Barry C. Assessment of affect in advanced Alzheimer's disease: the Dementia Mood Picture Test. J Gerontol Nurs. 1995 Mar;21(3):44-6. doi: 10.3928/0098-9134-19950301-09. No abstract available. — View Citation

Tappen RM, Williams CL. Development and testing of the Alzheimer's Disease and Related Dementias Mood Scale. Nurs Res. 2008 Nov-Dec;57(6):426-35. doi: 10.1097/NNR.0b013e31818c3dcc. — View Citation

van der Ploeg ES, Eppingstall B, Camp CJ, Runci SJ, Taffe J, O'Connor DW. A randomized crossover trial to study the effect of personalized, one-to-one interaction using Montessori-based activities on agitation, affect, and engagement in nursing home residents with Dementia. Int Psychogeriatr. 2013 Apr;25(4):565-75. doi: 10.1017/S1041610212002128. Epub 2012 Dec 14. — View Citation

van der Steen JT, van Soest-Poortvliet MC, van der Wouden JC, Bruinsma MS, Scholten RJ, Vink AC. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2017 May 2;5(5):CD003477. doi: 10.1002/14651858.CD003477.pub3. — View Citation

Witek MA, Clarke EF, Wallentin M, Kringelbach ML, Vuust P. Syncopation, body-movement and pleasure in groove music. PLoS One. 2014 Apr 16;9(4):e94446. doi: 10.1371/journal.pone.0094446. eCollection 2014. Erratum In: PLoS One. 2015;10(9):e0139409. — View Citation

* Note: There are 35 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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