'Caregivers' Experiences of a Singing Training Program to Support Person-Centered Dementia Care.

Music-based interventions are acknowledged to be accessible and beneficial to people living with dementia. As part of an over-arching research project exploring the contributions of person-centered caregiver singing (PCCS) intervention to caregiver's provision of care, this study aimed to explore caregiver's experiences of a PCCS training program. 8 caregivers across 2 care homes in South Africa participated in 4 iterative participatory cycles aimed at refining the training protocol. We completed a thematic analysis of semi-structured interviews of caregivers' experiences of the training. 3 themes emerged: workshop components contributed to positive learning experiences; caregivers' increased knowledge and insight into dementia, music, and personhood; and caregivers' enhanced self-efficacy which encompassed their emotional wellbeing, self-awareness, and confidence. Our study highlights caregivers' self-efficacy, self-hood, and personhood as valuable benefits in person-centered care training. Caregivers experienced training as both professionally and personally beneficial. While PCCS supported a shift toward a person-centered care approach, further research would help establish approaches to support sustainability of PCCS training and use in wider contexts.

Remini-Sing RCT: Therapeutic Choir Participation for Community-Dwelling People with Dementia and Their Primary Caregivers.

Dementia negatively affects the wellbeing of both caregivers and care recipients. Community-based therapeutic choir singing offers opportunities for music participation and social engagement that are accessible and mutually enjoyable for people with dementia and their family caregivers and promotes shared and meaningful musical interactions, which may support relationship quality. This study aimed to investigate the impact of the Remini-Sing therapeutic choir intervention on relationship quality, quality of life, depression, and social connectedness for dyads, as well as caregiver burden and care recipient anxiety. A randomized-controlled trial design was used with a target sample of 180 dyads. Due to recruitment difficulties, 34 participant dyads were recruited and randomly assigned to a 20-week group singing condition (n = 16) or a waitlisted control group (n = 18). Participant dyads consisted of people with dementia and their family caregivers who resided at home in the community. The Remini-Sing therapeutic choirs were held in community settings. Assessments were conducted by masked assessors at baseline, 11 weeks, and 21 weeks. Twenty-one dyads completed assessments at the primary timepoint (Week 11). Issues with recruitment and retention resulted in an unpowered study with no statistically significant findings. Mean decreases in anxiety and depression for choir participants with dementia were supported by medium to large effect sizes, indicating a potential intervention effect to be explored in future powered studies. Key learnings related to study design are discussed regarding recruitment, retention, participant burden, and sustainability, with recommendations made for future dementia research.

The experiences of people living with dementia and their care partners participating in an online therapeutic songwriting program.

BACKGROUND AND AIM: Despite the impact of dementia on close care relationships, accessible therapeutic services for people living with dementia and their care partners remain scarce. Further, there is an increasing demand for online services, highlighting the need for ongoing telehealth research. This study aimed to explore the experiences of people living with dementia and their informal and formal care partners following participation in a 10-week online therapeutic songwriting program. METHODS: The songwriting program included four duo and six group sessions facilitated by a music therapist. Post-program semi-structured interviews were analysed using thematic analysis. FINDINGS: Nine people with dementia and six care partners (nine duos) participated in the program. Five duos were in spousal relationships and four people with dementia participated with a formal care partner. Participants attended an average of four duo sessions and three group sessions. Six people with dementia and five care partners participated in post-program interviews. Four themes were developed: (1) No one else does this; (2) It's all about us as people; (3) After the sessions we'd come out buzzing; and (4) The journey was as important as the product. CONCLUSIONS: Participants highlighted songwriting as a unique opportunity to connect with music, experience welcomed challenges, and spend 'real time' together. The program drew on participants' lived experience and promoted connection with others, resulting in feelings of enjoyment, enhanced mood, and achievement. Participants valued both the songwriting process and song product, emphasising the importance of sensitive and skilful facilitation. Our findings suggest that these distinct benefits were not available through other support services. Further, online songwriting is a viable option for people living with dementia and their care partners where in-person sessions are not available or accessible.

Person-centred caregiver singing for people living with dementia in South Africa: A mixed methods evaluation of acceptability, feasibility, and professional caregivers' experiences.

BACKGROUND: Dementia care in South Africa faces challenges including a paucity of published research, a prevalent medical model in healthcare, and inadequate caregiver training. Music is a meaningful psychosocial intervention in dementia care, yet its application is not always safe and effective. A training protocol was codesigned to enhance caregivers' delivery of person-centred care through attuned, live singing. OBJECTIVES: This study explored the acceptability and caregivers' experiences of a person-centred caregiver singing (PCCS) protocol in South Africa. METHODS: A PCCS workshop was applied at seven aged care homes in Cape Town, South Africa. Forty-one formal caregivers adhered to inclusion criteria and consented to attend one workshop on PCCS. Mixed methods data collection was obtained from questionnaires containing a Likert scale and written reflections. Quantitative data were analysed through nonparametric tests and narrative descriptions, and qualitative data through thematic content analysis. Findings were integrated deductively using seven components of acceptability. RESULTS: Findings converged to show caregivers' positive experiences, highlighting observed improvements in residents' wellbeing, caregivers' capabilities, empathic connection, and person-centred care beyond the one-on-one. Caregivers' limited song repertoire and residents' unpredictability hindered implementation, however, the skills acquired appeared useful and applicable. CONCLUSIONS: Integration of findings suggests the acceptability of PCCS as caregivers experienced PCCS as a helpful, easy-to-implement intervention that contributes to their delivery of person-centred care. Further research focused on caregiver self-efficacy, empathy, and caregivers' own personhood is needed as well as determining the most effective strategies to ensure maximum uptake and sustainability in the sector. PATIENT OR PUBLIC CONTRIBUTION: Formal caregivers participated in this study, both attending the training and implementing the singing protocol with residents in their care at their respective care homes. The people living with dementia residing at the care home were recipients of the singing protocol but not included as participants in the research.

Development of a person-centered caregiver singing model for formal caregivers of people living with dementia in South Africa.

This action research study explored the co-design of a person-centered caregiver singing (PCCS) protocol and caregivers' experiences of applying the PCCS intervention with people living with dementia. Eight caregivers across two care homes participated in four iterative cycles aimed at refining the training. Qualitative data collected from semi-structed group interviews, individual interactions and researcher reflections were analysed via thematic analysis which informed the refinements to the training protocol. A Person-Centered Caregiver Singing Model was developed from the thematic findings relating to caregivers' experiences of applying the PCCS intervention: enhanced caregiver capabilities, resident's wellbeing, improved relationship, the positive ecological shift, and ease of caregiving. PCCS fostered caregivers' empathy and self-efficacy, helping them better attune to and meet the needs of people with dementia. Findings suggest music therapists could share music therapy-informed skills with caregivers for use in daily care. Further research would be beneficial to understand the relationship between live music interventions and caregivers' self-efficacy and empathy, and to explore the training barriers in South Africa.

Learning to use music as a resource: the experiences of people with dementia and their family care partners participating in a home-based skill-sharing music intervention: a HOMESIDE sub-study.

An increasing number of people with dementia receive informal care from family members to help them remain living in the community. Music therapy is particularly beneficial for supporting the wellbeing of people living with dementia. However, little is known about how music therapy might support people with dementia and their family care partners as dyads. This study explored the experiences of six dyads participating in a 12-week home-based skill-sharing music intervention facilitated by a music therapist. We examined their experiences during the intervention period and in the 3-6 months following. This study was conducted within a larger randomised control trial, HOMESIDE. Data was collected through video-recorded music-based interviews, participant diaries, and a semi-structured interview. Data was analysed using an abductive and relational-centred research approach in consideration of the Contextual Connection Model of Health Musicking for People Living with Dementia and Their Family Care Partners. The study found fifteen themes that describe dyads' supported experiences of sharing music in their homes. These were organised into three global themes: (1) experiences were shaped by complex influences; (2) a connected musical ecosystem; and (3) music was a resource for wellbeing. This study highlighted the important role of personalised facilitation and the therapeutic relationship as dyads learned to use music as a resource through a process of trial and error. The implications for skill-sharing, indirect music therapy and direct music therapy practice are discussed.

Training formal caregivers in the use of live music interventions during personal care with persons living with dementia: a systematic mixed studies review.

OBJECTIVES: To examine research on the training of formal caregivers in live music interventions within care situations with persons with dementia. METHODS: This review was registered with PROSPERO (CRD42020196506). PubMed, PsycINFO (Ovid), MEDLINE, Discovery EBSCO, Embase, CINAHL (Complete), AMED and ProQuest Dissertations and Theses Global were searched in September 2020 and again in October 2022. English, peer-reviewed studies on formal caregivers trained in using live music when caring one-on-one with persons with dementia were included. The Mixed Methods Assessment Tool (MMAT) was employed to assess quality, and narrative synthesis with effect sizes (Hedges-g) and thematic analysis were used for quantitative and qualitative studies respectively. RESULTS: Nine studies (four qualitative, three quantitative, two mixed methods studies) were included. Quantitative studies demonstrated significant differences for music training on outcomes measuring agitation and emotional expression. Thematic analysis yielded five themes: emotional wellbeing; mutual relationship; shifts in caregivers' experiences; care environment; and insights into person-centered care. CONCLUSION: Training for staff in live music interventions may benefit the delivery of person-centered care by supporting communication, easing care, and capacitating caregivers to meet the needs of persons with dementia. Findings appeared context specific due to high heterogeneity and small sample sizes. Further research on quality of care and caregiver outcomes, and sustainability of training is recommended.

A qualitative systematic review of the experiences of sharing music for people living with dementia and their family care partners: the thread of connection.

BACKGROUND: There is a global need for interventions that support the wellbeing of people living with dementia and their family care partners. Studies show that shared musical activities may achieve this. Our systematic review aimed to synthesise existing research exploring dyads' experiences of shared musical activities across a range of contexts. METHOD: From 31 October 2020 we searched PubMed, PsycInfo, CINAHL Complete, EMBASE, RILM, Web of Science Core Collection, Google Scholar and ProQuest Dissertations & Theses for studies published up to 14 April 2021, and hand searched five music therapy journals plus citation lists. Thirteen qualitative studies reporting on dyads' experiences and perspectives of shared musical activities across a range of settings were included. Studies with mixed populations or mixed modality interventions were excluded. We analysed the final studies using thematic synthesis, engaging in reflective discussions and reflexivity throughout. The quality of included studies was assessed using the CASP qualitative checklist. This study is registered on PROSPERO: CRD42020169360. RESULTS: Six themes were identified from 13 studies: 1) shared musical activities support wellbeing for people living with dementia, 2) music groups become ecological systems, 3) shared musical activities are experienced differently over time, 4) shared musical activities are experienced by me and as we, 5) music is a supportive structure, and 6) the thread of connection (an overarching theme). A GRADE-CERQual assessment found moderate to high confidence in these findings. Findings informed the development of the Contextual Connection Model of Health Musicking. CONCLUSION: Shared musical activities foster experiences of connection for people living with dementia and their family care partners. Experiences of connection are supported through professional facilitation and the structural aspects of music, and are influenced by the setting and changes over time. These experiences of connection play a central role in supporting dyadic and individual wellbeing. These findings are largely relevant to a western cultural context; future research should seek to include more diverse cultural experiences.

Music listening interventions for physical activity: a systematic review and meta-analysis of randomised controlled trials.

PURPOSE: Music listening is widely used during exercise, but effects on physical activity are unknown. This review aimed to examine the effectiveness of music listening on physical activity of adults. MATERIALS AND METHODS: Searches were conducted until September 2022. Eligible randomised controlled trials examined intentional music listening to enhance physical activity in adults. Trials were assessed using the Revised Cochrane risk-of-bias tool. The GRADE approach assessed certainty of evidence. RESULTS: One high and two low risk-of-bias trials (113 participants, 63-68 years) from cardiac and pulmonary rehabilitation programs were included. Moderate certainty evidence favoured music listening for total amounts of physical activity (n = 112, δ = 0.32, 95% CI = -0.06-0.70) and weekly moderate intensity physical activity (n = 88, MD = 52 min, 95% CI = -8-113). Low certainty evidence favoured music listening for exercise capacity (6-min walk test) (n = 79, MD = 101 metres, 95% CI = 2.32-199.88). CONCLUSIONS: There is imprecise, moderate certainty evidence that music listening increases physical activity by a small amount in older adults. Future research including adults of all ages with and without health conditions might investigate music listening with focussed behaviour change interventions.IMPLICATIONS FOR REHABILITATIONThere is uncertainty in the current evidence but listening to music may lead to small increases physical activity in older adults with health conditions.Listening to music while walking may lead to improved exercise capacity.Rehabilitation professionals might consider using music listening as an adjunct with focussed behaviour change interventions aiming to increase physical activity.

The HOMESIDE Music Intervention: A Training Protocol for Family Carers of People Living with Dementia.

Background: The number of people living with dementia (PwD) worldwide is expected to double every 20 years. Many continue living at home, receiving support from family caregivers who may experience significant stress, simultaneously to that of the PwD. Meaningful and effective home-based interventions to support PwD and their caregivers are needed. The development of a theory- and practice-driven online home-based music intervention (MI) is delivered by credentialed music therapists, nested within the HOMESIDE RCT trial. Methods: Dyads including the PwD and their family carer are randomised to MI, reading (RI) or standard care (SC). MI aims to support health wellbeing and quality of life by training caregivers to intentionally use music (singing, instrument playing, movement/dancing, and music listening) with their family member (PwD) in daily routines. MI is underpinned by cognitive, relational, social, and psychological theories of mechanisms of change. Results: Preliminary sub-cohort results analyses show MI can be delivered and is accepted well by participants and music-therapist interventionists across five countries. Conclusions: The specialist skills of a music therapist through MI enable carers to access music when music therapists are not present, to meet carer and PwD needs. Music therapists embrace this changing professional role, observing therapeutic change for members of the dyads.

Positive Psychology in Therapeutic Songwriting for People Living with Late-Life Depression-An Intervention Protocol.

(1) Background: An increasing number of people are living with late-life depression, yet non-pharmacological treatments to help manage symptoms are limited. Two interventions, positive psychology and music therapeutic songwriting, have independently led to decreased depressive symptoms and an improved wellbeing in older people over 65 years old. (2) Methods: This article describes the development of a therapeutic songwriting program for people living with late-life depression. Knowledge from positive psychology and therapeutic songwriting was combined to maximize the potential benefits. (3) Results: The intervention program has ten weekly 45 min sessions that incorporate elements from positive psychology into therapeutic songwriting. Using a three-song approach encompassing ongoing musical practices, different positive psychology interventions were incorporated to support the experiences associated with a flourishing life. The intervention protocol for older people presented here is distinct from previous deficit-orientated approaches in that it shifts the focus to positive experiences, resources, and the individual's ability to decrease their own depressive symptoms and improve their wellbeing. (4) Discussion: This protocol presenting a therapeutic songwriting program meets the need to develop new non-pharmacological treatment options. However, further studies are needed to examine the feasibility and impact of the intervention program on late-life depression and wellbeing in older people.

How Singing can Help People With Dementia and Their Family Care-Partners: A Mixed Studies Systematic Review With Narrative Synthesis, Thematic Synthesis, and Meta-Integration.

Background: Recent research on the efficacy of music-based interventions for people with dementia have focused on specific outcomes and methods, and singing has been noted as a particularly beneficial activity. However, due to heterogeneity of research methods, there is a need to synthesise the findings of both quantitative and qualitative research in order to better understand both the impact and potential mechanisms of singing for people in this population. Method: This systematic review included quantitative, qualitative and mixed-methods studies, and analysed these using a systematic mixed-studies synthesis (with a results-based convergent approach). Quantitative and qualitative data were initially synthesised using a narrative synthesis and thematic synthesis method, respectively, before a final meta-integration method was used to synthesise common themes across the two data forms. Results: Electronic and hand search strategies revealed 1,815 relevant studies, 40 of which met the full eligibility criteria. Narrative synthesis of quantitative data revealed six key outcome areas (quality of life; psychological well-being; cognition; engagement; activities of daily living; care-partner well-being), and thematic synthesis of qualitative data generated seven themes relating to the impact and mechanisms of singing (pragmatic elements; social benefits; mood; identity; memory; flow-on effects; and relationships). Meta-integration identified four key areas relating to the impact and mechanisms of singing for people with dementia and care-partners: psychological well-being, quality of life, cognition, and care-partner well-being. Conclusion: Results from the syntheses suggest that singing can positively impact the lives of people with dementia and their care-partners, although due to heterogeneity of study design and outcome measures, it is difficult to draw conclusions based on quantitative data alone. Qualitative data provides further context and insights from participant perspectives, and when integrated with quantitative data, contextual factors that may influence the benefits that participants experience from singing are revealed.

Strategies for Recruiting People With Dementia to Music Therapy Studies: Systematic Review.

Positive effects of music therapy for people with dementia and their family carers are reported in a growing number of studies. However, small sample sizes or low recruitment rates often limit the success of these research studies. More adequately powered evidence-based studies are needed to impact policy and funding in dementia care. This systematic review examined recruitment strategies in music therapy clinical trials involving people living with dementia and/or their family carers. Eligible studies described enrolment, consent, accrual, or recruitment methods as well as recruitment or consent rates. Thirty studies with a total of 1,192 participants were included. Recruitment and conversion rates in residential aged care facilities (RACFs) (14 studies) were substantially higher than in community-based studies (16 studies). Whereas studies in RACFs most commonly recruited participants through staff approaching residents face-to-face or conversing with residents' legal guardians, community-based studies utilized a vast array of strategies, including staff referral, demonstrations/information sessions by researchers, advertisements, and direct contact with residents. Recruitment rates are likely to be higher when recruiters have an existing relationship with potential participants and when an independent third-party dementia organization is involved. Randomized controlled trials led to equally or greater recruitment conversion rates than other designs. Findings suggest that recruitment in dementia trials is complex, challenging, and needs thorough planning and consideration to be time- and cost-effective. Future studies should include reporting of recruitment strategies, enrolment rates, and related aspects so that researchers can better design recruitment strategies and estimate resources needed to reach the target sample size.

"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.

HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial.

INTRODUCTION: Pharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs. METHODS AND ANALYSIS: A large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison). ETHICS AND DISSEMINATION: Ethical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community. TRIAL REGISTRATION NUMBERS: ACTRN12618001799246p; NCT03907748.

Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial.

INTRODUCTION: In older adults, dementia and depression are associated with individual distress and high societal costs. Music interventions such as group music therapy (GMT) and recreational choir singing (RCS) have shown promising effects, but their comparative effectiveness across clinical subgroups is unknown. This trial aims to determine effectiveness of GMT, RCS and their combination for care home residents and to examine heterogeneity of treatment effects across subgroups. METHODS AND ANALYSIS: This large, pragmatic, multinational cluster-randomised controlled trial with a 2×2 factorial design will compare the effects of GMT, RCS, both or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. We will randomise 100 care home units with ≥1000 residents in total across eight countries. Each intervention will be offered for 6 months (3 months 2 times/week followed by 3 months 1 time/week), with extension allowed if locally available. The primary outcome will be the change in the Montgomery-Åsberg Depression Rating Scale score at 6 months. Secondary outcomes will include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, psychotropic drug use, caregiver burden, quality of life, mortality and costs over at least 12 months. The study has 90% power to detect main effects and is also powered to determine interaction effects with gender, severity and socioeconomic status. ETHICS AND DISSEMINATION: Ethical approval has been obtained for one country and will be obtained for all countries. Results will be presented at national and international conferences and published in scientific journals. TRIAL REGISTRATION NUMBERS: NCT03496675; Pre-results, ACTRN12618000156280.

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.