Clinical effectiveness of music interventions for dementia and depression in elderly care (MIDDEL): Australian cohort of an international pragmatic cluster-randomised controlled trial.

BACKGROUND: Dementia and depression are highly prevalent and comorbid conditions among older adults living in care homes and are associated with individual distress and rising societal costs. Effective, scalable, and feasible interventions are needed. Music interventions have shown promising effects, but the current evidence base is inconclusive. The present study aimed to determine the effectiveness of two different music interventions on the depressive symptoms of people with dementia living in residential aged care. METHODS: We implemented a 2 × 2 factorial cluster-randomised controlled trial to determine whether group music therapy (GMT) is more effective than no GMT with standard care, or recreational choir singing (RCS) is more effective than no RCS with standard care, for reducing depressive symptoms and other secondary outcomes in people with dementia with mild to severe depressive symptoms living in residential aged care. Care home units with at least ten residents were allocated to GMT, RCS, GMT plus RCS, or standard care, using a computer-generated list with block randomisation (block size four). The protocolised interventions were delivered by music therapists (GMT) and community musicians (RCS). The primary outcome was Montgomery-Åsberg Depression Rating Scale score at 6 months, assessed by a masked assessor and analysed on an intention-to-treat basis using linear mixed-effects models, which examined the effects of GMT versus no-GMT and RCS versus no-RCS, as well as interaction effects of GMT and RCS. We report on the Australian cohort of an international trial. This trial is registered with ClinicalTrials.gov, NCT03496675, and anzctr.org.au, ACTRN12618000156280. FINDINGS: Between June 15, 2018, and Feb 18, 2020, we approached 12 RAC facilities with 26 eligible care home units and, excluding six units who could not be enrolled due to COVID-19 lockdowns, we screened 818 residents. Between July 18, 2018, and Nov 26, 2019, 20 care home units were randomised (318 residents). Recruitment ceased on March 17, 2020, due to COVID-19. The primary endpoint, available from 20 care home units (214 residents), suggested beneficial effects of RCS (mean difference -4·25, 95% CI -7·89 to -0·62; p=0·0221) but not GMT (mean difference -0·44, -4·32 to 3·43; p=0·8224). No related serious adverse events occurred. INTERPRETATION: Our study supports implementing recreational choir singing as a clinically relevant therapeutic intervention in reducing depressive symptoms for people with dementia in the Australian care home context. FUNDING: National Health and Medical Research Council, Australia.

Demographic and clinical profile of residents living with dementia and depressive symptoms in Australian private residential aged care: Data from the Music Interventions for Dementia and Depression in ELderly care (MIDDEL) cluster-randomised controlled trial.

OBJECTIVES: 1) To describe the demographic and clinical characteristics of residents with dementia and depressive symptoms in the Australian private residential aged care (RAC) context; and 2) to investigate the association between neuropsychiatric symptoms, depression and quality of life and their interactions with dementia severity. METHODS: This study examined the baseline demographic and clinical data from the Australian arm of the Music Interventions for Dementia and Depression in ELderly care (MIDDEL) study, a multinational, cluster-randomised controlled trial. Demographic characteristics, neuropsychiatric symptoms, depression, quality of life and dementia severity were collected in 330 residents of 12 private RAC facilities across Melbourne, Australia. Descriptive statistics, the Kruskal-Wallis test and the Pearson Χ2 test were used to describe and compare the demographic and clinical characteristics according to dementia severity. The association between clinical characteristics and dementia severity was examined using linear regression analyses. RESULTS: Residents' mean age was 86.5 years, 69% were female, and 44.2% had severe dementia. There were no significant differences between the dementia severity groups on age, sex and education. Residents with severe dementia were more likely to have a diagnosis of Alzheimer's disease (40.3%) and be born overseas (46.8%). Higher levels of neuropsychiatric symptoms, distress and depressive symptoms, and lower quality of life were associated with more severe dementia. CONCLUSIONS: The findings from our study highlight the diverse and complex care needs of people living with dementia in the Australian private RAC setting, which can be used to inform targeted, person-centred dementia care planning, staff training and allocation of resources.

Therapeutic music interventions with people with dementia living in residential aged care: Perspectives of residents, family members and care home staff from a cluster randomised controlled trial.

BACKGROUND: Despite growing support for the benefits of music interventions in dementia care, the perspectives of people with dementia, their families and carers are often missing from the research. This study explored multiple perspectives and first-person experiences of group music interventions delivered within a large cluster randomised controlled trial examining the effectiveness of group music therapy (GMT) and recreational choir singing (RCS) with people with dementia living in residential-aged care (RAC) settings. METHODS: Focus group and individual interviews with residents with dementia (n = 4), family members (n = 5) and care home staff (n = 15) were conducted following completion of the 6-month GMT and/or RCS intervention and analysed using inductive thematic analysis. FINDINGS: Three main themes were identified as follows: (1) direct and indirect intrapersonal benefits, (2) direct and indirect interpersonal benefits and (3) therapeutic music interventions versus entertainment. GMT and RCS supported residents' mood, enjoyment, engagement and connectedness to self and others within and post-sessions, with flow-on effects to family members, care staff and the care home environment. Participants differentiated GMT and RCS from other forms of music engagement in the RAC facilities and described feelings of post-programme loss, highlighting ongoing meaning in active therapeutic music interventions. CONCLUSION: This research highlights the need for increased access to sustainable and meaningful activities, such as purposefully designed therapeutic music interventions in RAC. Improving knowledge about the distinct benefits of therapeutic music interventions compared with other forms of music engagement in RAC may assist nursing staff to make appropriate treatment planning decisions regarding therapeutic music programmes to meet the complex needs of residents with dementia.

"Doing Things Together Is What It's About": An Interpretative Phenomenological Analysis of the Experience of Group Therapeutic Songwriting From the Perspectives of People With Dementia and Their Family Caregivers.

BACKGROUND: The wellbeing of people living with dementia and their family caregivers may be impacted by stigma, changing roles, and limited access to meaningful opportunities as a dyad. Group therapeutic songwriting (TSW) and qualitative interviews have been utilized in music therapy research to promote the voices of people with dementia and family caregivers participating in separate songwriting groups but not together as dyads. PROCEDURES: This study aimed to explore how ten people with dementia/family caregiver dyads experienced a 6-week group TSW program. Dyads participated in homogenous TSW groups involving 2-4 dyads who were either living together in the community (2 spousal groups) or living separately because the person with dementia resided in a care home (1 family group, 1 spousal group). The TSW program, informed by personhood, couplehood, family centered and group process frameworks, involved creating original lyrics through song parody and song collage. Qualified Music Therapists facilitated sessions and interviewed each dyad separately. Interviews were analyzed using interpretative phenomenological analysis. FINDINGS: Five recurrent group themes were developed, indicating group TSW: (1) was a positive shared experience, benefiting both members of the dyad and motivating further engagement with music; (2) stimulated mental processes and reignited participants' interests and skills; (3) provided meaningful opportunities for reflection and connection with memories and life experiences; and (4) prompted interaction and collaboration, leading to social connections, empathic relationships and experiences of inclusion. Participants also highlighted how: (5) the facilitated process supported engagement, highlighting abilities and challenging doubts. CONCLUSION: Dyads identified group TSW as an opportunity to recognize strengths, voice ideas and opinions, share meaningful experiences, and do "more with music." Participants valued TSW as a new, creative and stimulating experience that enabled connection with self and others and led to feelings of pride and achievement. Our findings further recognize how therapeutic intention and approach were reflected in participants' engagement and responses regardless of dementia stage and type, dyad relationship, or musical background. This research may broaden perspectives and expand understanding about how people with dementia and their family caregivers access and engage in music therapy.

Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team.

BACKGROUND: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. This paper describes process and resource assessment during recruitment, collection of outcome measures and intervention delivery, and presents learnings and considerations for conducting trials in RACFs with people living with dementia. METHODS: Data were collected across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as reasons for participant non-attendance at the interventions. RESULTS: Time between contacting next of kin and receiving formal consent often exceeded 45 days. The ratio of time between direct and indirect research activity was approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. CONCLUSIONS: Research planning should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. TRIAL REGISTRATION AUSTRALIAN AND NEW ZEALAND CLINICAL TRIAL REGISTRY ANZCTR12618000156280 1/02/2018 HTTP//ANZCTRORGAU/TRIAL/REGISTRATION/TRIALREVIEWASPX?ACTRN=12618000156280: A.

"It's Feasible to Write a Song": A Feasibility Study Examining Group Therapeutic Songwriting for People Living With Dementia and Their Family Caregivers.

BACKGROUND: Psychosocial interventions for people with dementia and their family caregivers together may sustain relationship quality and social connection. No previous music therapy research has examined the effects of group therapeutic songwriting (TSW) attended by people with dementia/family caregiver dyads. METHODS: This pre-post feasibility study aimed to examine the acceptability of a group TSW intervention for people with dementia/family caregiver dyads and test the sensitivity of the following outcomes: Quality of the Caregiver-Patient Relationship (QCPR, primary); Cornell Scale for Depression in Dementia (CSDD) and Quality of Life-Alzheimer's Dementia for people with dementia, Patient Health Questionnaire-9, Assessment of Quality of Life-8 Dimensions (AQoL-8D); and Zarit Burden Interview for family caregivers. Six weekly 1 h sessions guided participants to identify preferred music, brainstorm ideas, create lyrics, and record songs. Qualitative interviews were conducted with dyads who completed the intervention. RESULTS: Fourteen dyads were recruited and completed baseline assessments. Participants with dementia were aged 62-92 years (M = 77, SD = 11). Caregiver participants (11 spouses, two daughters, one son) were aged 54-92 years (M = 67, SD = 10.1). Four dyads withdrew owing to declining health or inconvenience before the program commenced (n = 2) and after attending 1-2 sessions (n = 2). Ten dyads formed four homogeneous TSW groups (71% completion). No statistically significant changes were detected for any measure. High QCPR ratings at baseline (M = 57.1) and follow-up (M = 57.4) demonstrated sustained relationship quality. For participants with dementia, large effect sizes for the CSDD suggested trends toward decreased depression (d = -0.83) and improved mood (d = -0.88). For family caregivers, a large effect size suggested a trend toward improvement for the AQoL-8D sub-domain examining independent living (d = -0.93). Qualitative data indicated that session design and delivery were acceptable, and TSW was a positive shared experience with personal benefits, which supported rather than changed relationship quality. CONCLUSION: High retention and qualitative data indicate that TSW was well received by participants. Effect sizes suggest that group TSW for dyads may have beneficial impacts on depression for people with dementia and quality of life for family caregivers. Future research with a fully powered sample is recommended to further examine the psychosocial impacts of group TSW for people living with dementia/family caregiver dyads.

Exploring self-concept, wellbeing and distress in therapeutic songwriting participants following acquired brain injury: A case series analysis.

Acquired brain injury (ABI) presents a significant threat to sense of self and necessitates a complex process of psychosocial adjustment. Self-concept changes remain understudied in the early stages of inpatient rehabilitation. The aim of the current study was to examine changes in self-concept, distress, wellbeing and functional skills for five inpatients undertaking a music therapy intervention within a subacute rehabilitation centre in Victoria, Australia. Participants completed a six-week, 12-session therapeutic songwriting programme to produce past-, current- and future-self-focused songs. A range of self-concept, subjective wellbeing and distress measures were completed pre-, mid- and post-intervention. A descriptive case series approach was applied to determine trends in pre-post scores for five individual cases. Participants showing the greatest gains across self-concept and subjective wellbeing indices also showed the greatest functional gains on the Functional Independence Measure (FIM) from admission to discharge. The current study highlights the importance of examining early changes in self-concept, wellbeing and distress in subacute rehabilitation, and suggests that individualised songwriting programmes warrant further research attention in neurological populations.

Treatment Fidelity in a Music Therapy Multi-site Cluster Randomized Controlled Trial for People Living With Dementia: The MIDDEL Project Intervention Fidelity Protocol.

High-quality clinical trials testing music therapy interventions have become more prevalent over the past decade. However, recent reviews of published music therapy trials reveal that reporting of strategies used to ensure treatment fidelity is lacking. Treatment fidelity refers to methodological strategies, put in place prior to clinical trial implementation, to strengthen the reliability and validity of intervention delivery and, therefore, safeguard research quality. This paper outlines strategies developed and implemented during the pilot phase of a randomized controlled trial involving the testing of music interventions for people living with dementia and presenting with symptoms of depression. We discuss the five recognized components of fidelity (study design, training intervention providers, treatment integrity, treatment differentiation, and treatment receipt) and describe our methods for training music intervention providers and testing interventionist competence prior to trial commencement, approaches to intervention delivery supervision, and methods for assessing intervention protocol adherence.

A therapeutic songwriting intervention to promote reconstruction of self-concept and enhance well-being following brain or spinal cord injury: pilot randomized controlled trial.

OBJECTIVE: To determine the size of the effects and feasibility (recruitment and retention rates) of a therapeutic songwriting protocol for in-patients and community-dwelling people with acquired brain injury or spinal cord injury. DESIGN: Randomized controlled trial with songwriting intervention and care-as-usual control groups, in a mixed measures design assessed at three time points. PARTICIPANTS: A total of 47 participants (3 in-patients with acquired brain injury, 20 community participants with acquired brain injury, 12 in-patients with spinal cord injury, and 12 community participants with spinal cord injury: 23 1208 days post injury). INTERVENTIONS: The intervention group received a 12-session identity-targeted songwriting programme, where participants created three songs reflecting on perceptions of past, present, and future self. Control participants received care as usual. MEASURES: Baseline, postintervention, and follow-up measures comprised the Head Injury Semantic Differential Scale (primary outcome measure), Patient Health Questionnaire-9, Emotion Regulation Questionnaire, and Satisfaction with Life Scale. RESULTS: No significant between group pre-post intervention differences were found on the primary self-concept measure, the Head Injury Semantic Differential Scale ( p = 0.38, d = 0.44). Significant and large effect sizes from baseline to post between groups in favour of the songwriting group for Satisfaction with Life ( p = 0.04, n2 p = 0.14). There were no significant between group pre-post interaction effects for the Emotion Regulation Suppression subscale ( p = 0.12, n2 p = -0.08) although scores decreased in the songwriting group over time while increasing for the standard care group. There were no significant differences in baseline to follow-up between groups in any other outcome measures. Recruitment was challenging due to the small number of people eligible to participate combined with poor uptake by eligible participants, particularly the in-patient group. Retention rates were higher for the community-dwelling cohorts. CONCLUSION: This study demonstrates the challenges in recruitment and retention of participants invited to participate in a music therapy study. Findings suggest this identity-focused therapeutic songwriting protocols may be more beneficial for people who have transitioned from in-patient to community-contexts given the greater proportion of participants who consent and complete the intervention. Preliminary effects in favour of the intervention group were detected in a range of well-being measures suggesting that a larger study is warranted.

Remini-Sing: A Feasibility Study of Therapeutic Group Singing to Support Relationship Quality and Wellbeing for Community-Dwelling People Living With Dementia and Their Family Caregivers.

Background: Living at home following a diagnosis of dementia can be difficult for both the person living with dementia (PwD) and their family caregivers (FCG). Active group music participation may provide an avenue for emotional release, offer psychosocial support to caregivers and stimulate meaningful interaction between caregivers and loved ones with dementia. Therapeutic music interventions also have the capacity to facilitate reminiscence and social engagement and can help to manage challenging symptoms associated with dementia, such as anxiety, apathy, and agitation. Method: This feasibility study examined the acceptability of a 20-week therapeutic group singing intervention (Remini-Sing) and quantitative research assessments for PwD/FCG dyads living in the community. Quantitative measures for the following outcomes were tested for sensitivity and acceptability: relationship quality (PwD and FCG); life satisfaction, caregiver satisfaction, flourishing, and depression for FCGs; and anxiety, apathy, agitation, and quality of life for PwD. Quantitative assessments were conducted before, during (midway) and after 20 weeks of participation in a therapeutic singing group attended by the PwD and FCG together. The Remini-Sing intervention incorporated vocal warm ups, singing familiar songs, learning new songs, and opportunities for social interaction. Qualitative interviews were conducted with all dyads that completed the intervention. Results: Twelve PWD/FCG dyads were recruited and enrolled in the study. High participation and retention rates indicated that the intervention was received favorably by participants. There were no statistically significant changes on measures from pre to post intervention. However, favorable baseline scores on relationship quality and wellbeing measures were sustained over the 20-week intervention. The testing of these measures for feasibility also revealed that some were too difficult for PwD and thus yielded questionable results, some were potentially less relevant, and there were likely floor and ceiling effects on several of the measures utilized. Conclusions: This study demonstrated good feasibility for a research protocol and therapeutic group singing intervention for community-dwelling PwD and their FCGs. Participant reflections and researcher observations yielded useful information guiding the selection of quantitative outcome measures for future research in this area.

Meaning Making Process and Recovery Journeys Explored Through Songwriting in Early Neurorehabilitation: Exploring the Perspectives of Participants of Their Self-Composed Songs Through the Interpretative Phenomenological Analysis.

Objectives: This pilot study examined how 15 participants in early rehabilitation described their self-composed Songs 6- to 12-months following participation in a 6-week identity-focused songwriting program. Specific focus was given to the process of meaning making and identity reconstruction in the participants' self-composed songs. Methods: Data were collected through individual semi-structured interviews (n = 15) and analyzed using interpretative phenomenological analysis. Findings were developed idiographically as super-ordinate themes unique to each participant, then analyzed across cases to identify recurrent themes and subthemes. Results: Participants described the songwriting process as taking them through one of four distinct recovery journeys described by individuals following acquired neurodisability who underwent a focused therapeutic songwriting program. These included (1) re-conceptualizing values and shifting perspectives about self (my body is broken but my mind has been set free); (2) recognizing acquired inner resources to negotiate discrepancies in self (hope is there); (3) confirming existing values and identifying resources and coping strategies (I have what I need to move forward); (4) confirming previously held values and ongoing process of negotiating discrepancies in self (I don't yet have the answers). Conclusion: The current study provides insight into the nature and process of meaning making and recovery journeys perceived by individuals with neurodisability. Our findings suggest that songwriting could be a therapeutic tool to facilitate identity reconstruction in neurorehabilitation.

A Group Therapeutic Songwriting Intervention for Family Caregivers of People Living With Dementia: A Feasibility Study With Thematic Analysis.

This study aimed to test the feasibility of implementing a group songwriting program with family caregivers (FCGs) of people living with dementia. Fourteen FCGs consented to participate in either the songwriting group (n = 8) or control condition (n = 6). Participants completed baseline and 7-week measures of depression (PHQ-9), perceptions of their caregiving experience (PACQ), and perceptions of their relationship with the care recipient (QCPR). A six-session group songwriting program was implemented across two sites, focusing on participants co-creating a song about their caregiving experiences. Participation and retention rates were high suggesting the intervention was acceptable. An observed pre-post effect size for the PHQ-9 in the experimental group (d = 0.64) and control group (d = -0.33) suggests the measure is sensitive to change over a short period of time in this population and has the potential to detect significant change in a larger controlled trial. Qualitative analysis of focus group interviews suggested the songwriting process allowed participants to share their entire caregiver journey with others, differentiating the intervention from standard carer support groups. Participants described group songwriting as enabling them to find connections with other caregivers, create a group identity, and gain insight into their carer journey, subsequently leading to the development of inner strength and personal growth. Qualitative findings suggest coping may be a more relevant construct to measure than caregiver-patient relationship quality or caregivers' perception of caregiving.

Prospective Characterization of Cognitive Function in Typical and 'Brainstem Predominant'Progressive Supranuclear Palsy Phenotypes.

OBJECTIVE: Clinicopathological studies over the last decade have broadened the clinical spectrum of progressive supranuclear palsy (PSP) to include several distinct clinical syndromes. We examined the cognitive profiles of patients with PSP-Richardson's syndrome (PSP-RS) and two atypical 'brainstem predominant' PSP phenotypes (PSP-parkinsonism, PSP-P; and PSP-pure akinesia with gait freezing, PSP-PAGF) using a comprehensive neuropsychological battery. METHODS: Fourteen patients diagnosed as PSP-RS, three patients with PSP-P and four patients with PSP-PAGF were assessed using a comprehensive battery of neuropsychological tests. RESULTS: The typical PSP-RS subgroup demonstrated greater impairments in processing speed [t(19) = -4.10, p = 0.001 (d =1.66)] and executive function [t(19) = -2.63, p = 0.02 (d = 1.20)] compared to the 'brainstem predominant' PSP phenotype. CONCLUSION: This is the first prospective study to demonstrate that PSP-RS and 'brainstem predominant' PSP phenotypes can be differentiated on cognitive grounds. These differences correspond with variations in pathological profiles reported in the literature.

Frontal deficits differentiate progressive supranuclear palsy from Parkinson's disease.

The clinical differentiation of progressive supranuclear palsy from Parkinson's disease can be challenging, due to overlapping clinical features and a lack of diagnostic markers. Abnormalities in cognitive function form part of the clinical spectrums of these diseases and distinctive cognitive profiles may be helpful in differentiating these diseases in the diagnostic period. A comprehensive neuropsychological test battery was administered to 12 patients with clinically diagnosed progressive supranuclear palsy and 12 patients with Parkinson's disease matched for age and disease duration. Effect size (Cohen's d) was calculated for cognitive tests that were significantly different between groups. Patients with progressive supranuclear palsy performed significantly worse than those with Parkinson's disease on measures of processing speed, verbal fluency, planning, verbal abstract reasoning, verbal memory, and made more perseverative responses on a set shifting task. Measures of executive function, manual dexterity and processing speed were most diagnostically useful (Cohen's d > 2.0) in differentiating between progressive supranuclear palsy and Parkinson's disease. These findings suggest that more severe and prominent 'frontal' cognitive deficits in patients with progressive parkinsonism would be helpful in predicting progressive supranuclear palsy rather than Parkinson's disease and these findings may contribute to the development of diagnostic criteria.