Characteristics, outcomes, facilitators and barriers for psychosocial interventions on inpatient mental health dementia wards: a systematic review.

BACKGROUND: The National Institute for Health and Care Excellence guidelines state that psychosocial interventions should be the first line of treatment for people with dementia who are experiencing distress behaviours, such as agitation and depression. However, little is known about the characteristics and outcomes of psychosocial interventions or the facilitators and barriers to implementation on inpatient mental health dementia wards which provide care for people with dementia who are often experiencing high levels of distress. METHODS: A systematic search was conducted on MEDLINE, CINAHL, PsycINFO, Psychology and Behavioural Sciences Collection, and Scopus in May 2023, following PRISMA guidelines. Reference and citation searches were conducted on included articles. Peer-reviewed literature of any study design, relating to psychosocial interventions in inpatient mental health dementia wards, was included. One author reviewed all articles, with a third of results reviewed independently by a second author. Data were extracted to a bespoke form and synthesised using a narrative review. The quality of included studies was appraised using the Mixed Methods Appraisal Tool. RESULTS: Sixteen studies were included in the synthesis, which together included a total of 538 people with dementia. Study methods and quality varied. Psychosocial interventions delivered on wards included music therapy (five studies), multisensory interventions (four studies), multicomponent interventions (two studies), technology-based interventions (two studies), massage interventions (two studies) and physical exercise (one study). Reduction in distress and improvement in wellbeing was demonstrated inconsistently across studies. Delivering interventions in a caring and individualised way responding to patient need facilitated implementation. Lack of staff time and understanding of interventions, as well as high levels of staff turnover, were barriers to implementation. CONCLUSION: This review highlights a striking lack of research and therefore evidence base for the use of psychosocial interventions to reduce distress in this vulnerable population, despite current healthcare guidelines. More research is needed to understand which psychosocial interventions can reduce distress and improve wellbeing on inpatient mental health dementia wards, and how interventions should be delivered, to establish clinical and cost effectiveness and minimise staff burden.

Pain and mild cognitive impairment among adults aged 50 years and above residing in low- and middle-income countries.

BACKGROUND: Previous studies on the association between pain and cognitive decline or impairment have yielded mixed results, while studies from low- and middle-income countries (LMICs) or specifically on mild cognitive impairment (MCI) are scarce. Thus, we investigated the association between pain and MCI in LMICs and quantified the extent to which perceived stress, sleep/energy problems, and mobility limitations explain the pain/MCI relationship. METHODS: Data analysis of cross-sectional data from six LMICs from the Study on Global Ageing and Adult Health (SAGE) were performed. MCI was based on the National Institute on Aging-Alzheimer's Association criteria. "Overall in the last 30 days, how much of bodily aches or pain did you have?" was the question utilized to assess pain. Associations were examined by multivariable logistic regression analysis and meta-analysis. RESULTS: Data on 32,715 individuals aged 50 years and over were analysed [mean (SD) age 62.1 (15.6) years; 51.7% females]. In the overall sample, compared to no pain, mild, moderate, and severe/extreme pain were dose-dependently associated with 1.36 (95% CI = 1.18-1.55), 2.15 (95% CI = 1.77-2.62), and 3.01 (95% CI = 2.36-3.85) times higher odds for MCI, respectively. Mediation analysis showed that perceived stress, sleep/energy problems, and mobility limitations explained 10.4%, 30.6%, and 51.5% of the association between severe/extreme pain and MCI. CONCLUSIONS: Among middle-aged to older adults from six LMICs, pain was associated with MCI dose-dependently, and sleep problems and mobility limitations were identified as potential mediators. These findings raise the possibility of pain as a modifiable risk factor for developing MCI.

Is loneliness associated with mild cognitive impairment in low- and middle-income countries?

BACKGROUND: Loneliness may be a risk factor for mild cognitive impairment but studies on this topic are scarce, particularly from low- and middle-income countries (LMICs). Therefore, the aim of the present study was to investigate the association between loneliness and mild cognitive impairment (MCI) in six LMICs (China, Ghana, India, Mexico, Russia and South Africa). METHODS: Cross-sectional, community-based, nationally representative data from the WHO Study on global AGEing and adult health (SAGE) were analyzed. The definition of MCI was based on the National Institute on Ageing-Alzheimer's Association criteria. Multivariable logistic regression analysis and meta-analysis were conducted to assess associations. RESULTS: The final analytical sample consisted of 19,092 and 13,623 individuals aged 50-64 years (middle-aged adults) and ≥65 years (older adults), respectively. Among the middle-aged, overall, loneliness was associated with a non-significant 1.43 (95% confidence interval [CI] = 0.93-2.21) times higher odds for MCI although significant associations were observed in China (OR = 1.51; 95%CI = 1.08-2.09) and South Africa (OR = 3.87; 95%CI = 1.72-8.71). As for older adults, overall, there was a significant association between loneliness and MCI (OR = 1.52; 95%CI = 1.12-2.07). CONCLUSION: In this large representative sample of middle-aged and older adults from multiple LMICs, findings suggest that loneliness is associated with MCI. It may be prudent to consider reducing loneliness in low-economic settings to aid in the prevention of MCI and ultimately dementia.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

OBJECTIVE: To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. DESIGN: A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. SETTING: Participants' homes across Cambridgeshire, UK. SUBJECTS: Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. INTERVENTIONS: Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. MAIN MEASURES: Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. RESULTS: A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. CONCLUSION: It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT 02310438.

Effects of Improvisational Music Therapy vs Enhanced Standard Care on Symptom Severity Among Children With Autism Spectrum Disorder: The TIME-A Randomized Clinical Trial.

Importance: Music therapy may facilitate skills in areas affected by autism spectrum disorder (ASD), such as social interaction and communication. Objective: To evaluate effects of improvisational music therapy on generalized social communication skills of children with ASD. Design, Setting, and Participants: Assessor-blinded, randomized clinical trial, conducted in 9 countries and enrolling children aged 4 to 7 years with ASD. Children were recruited from November 2011 to November 2015, with follow-up between January 2012 and November 2016. Interventions: Enhanced standard care (n = 182) vs enhanced standard care plus improvisational music therapy (n = 182), allocated in a 1:1 ratio. Enhanced standard care consisted of usual care as locally available plus parent counseling to discuss parents' concerns and provide information about ASD. In improvisational music therapy, trained music therapists sang or played music with each child, attuned and adapted to the child's focus of attention, to help children develop affect sharing and joint attention. Main Outcomes and Measures: The primary outcome was symptom severity over 5 months, based on the Autism Diagnostic Observation Schedule (ADOS), social affect domain (range, 0-27; higher scores indicate greater severity; minimal clinically important difference, 1). Prespecified secondary outcomes included parent-rated social responsiveness. All outcomes were also assessed at 2 and 12 months. Results: Among 364 participants randomized (mean age, 5.4 years; 83% boys), 314 (86%) completed the primary end point and 290 (80%) completed the last end point. Over 5 months, participants assigned to music therapy received a median of 19 music therapy, 3 parent counseling, and 36 other therapy sessions, compared with 3 parent counseling and 45 other therapy sessions for those assigned to enhanced standard care. From baseline to 5 months, mean ADOS social affect scores estimated by linear mixed-effects models decreased from 14.08 to 13.23 in the music therapy group and from 13.49 to 12.58 in the standard care group (mean difference, 0.06 [95% CI, -0.70 to 0.81]; P = .88), with no significant difference in improvement. Of 20 exploratory secondary outcomes, 17 showed no significant difference. Conclusions and Relevance: Among children with autism spectrum disorder, improvisational music therapy, compared with enhanced standard care, resulted in no significant difference in symptom severity based on the ADOS social affect domain over 5 months. These findings do not support the use of improvisational music therapy for symptom reduction in children with autism spectrum disorder. Trial Registration: isrctn.org Identifier: ISRCTN78923965.

Individual music therapy for managing neuropsychiatric symptoms for people with dementia and their carers: a cluster randomised controlled feasibility study.

BACKGROUND: Previous research highlights the importance of staff involvement in psychosocial interventions targeting neuropsychiatric symptoms of dementia. Music therapy has shown potential effects, but it is not clear how this intervention can be programmed to involve care staff within the delivery of patients' care. This study reports initial feasibility and outcomes from a five month music therapy programme including weekly individual active music therapy for people with dementia and weekly post-therapy video presentations for their carers in care homes. METHODS: 17 care home residents and 10 care staff were randomised to the music therapy intervention group or standard care control group. The cluster randomised, controlled trial included baseline, 3-month, 5-month and post-intervention 7-month measures of residents' symptoms and well-being. Carer-resident interactions were also assessed. Feasibility was based on carers' feedback through semi-structured interviews, programme evaluations and track records of the study. RESULTS: The music therapy programme appeared to be a practicable and acceptable intervention for care home residents and staff in managing dementia symptoms. Recruitment and retention data indicated feasibility but also challenges. Preliminary outcomes indicated differences in symptoms (13.42, 95 % CI: [4.78 to 22.07; p = 0.006]) and in levels of wellbeing (-0.74, 95 % CI: [-1.15 to -0.33; p = 0.003]) between the two groups, indicating that residents receiving music therapy improved. Staff in the intervention group reported enhanced caregiving techniques as a result of the programme. CONCLUSION: The data supports the value of developing a music therapy programme involving weekly active individual music therapy sessions and music therapist-carer communication. The intervention is feasible with modifications in a more rigorous evaluation of a larger sample size. TRIAL REGISTRATION: Clinicaltrials.gov, number NCT01744600.

The HOMESIDE Study-A Research Project to Support People Living With Dementia and Their Family Caregivers: Preliminary Report on Reading Intervention.

The behavioral and psychological symptoms of dementia (BPSD) can be challenging for family caregivers to cope with, leading to distress and fatigue. It is therefore important to offer effective strategies to reduce the impact of BPSD. The HOMESIDE randomized controlled trial (RCT) was testing purposefully developed interventions to improve the quality of life and wellbeing of dyads of people with dementia and family caregivers as a result of reduction of BPSD. HOMESIDE RCT was conducted in Australia, Germany, Norway, Poland and the United Kingdom between 2019 and 2022. The study design was a three-arm parallel-group single-blinded, pragmatic RCT with a sample size of 432 dyads. Dyads were randomly allocated to one of three treatment conditions: Music Intervention plus Standard Care; or Reading Intervention plus Standard Care; or Standard Care only. The Reading Intervention (RI) within the HOMESIDE RCT aimed to evoke shared discussion, reminiscence, meaningful shared experiences and consequently enrich everyday life, interaction and the emotional connection between the caregiver (CG) and carereceiver (CR); as well as to enhance activities of daily living and to promote relaxation or stimulation as appropriate. This paper describes the underlying conceptual framework, the content, and delivery of the Reading Intervention within the HOMESIDE RCT.

Experiences of participant and public involvement in an international randomized controlled trial for people living with dementia and their informal caregivers.

BACKGROUND: This study was initiated and co-designed by a Participant and Public Involvement (PPI) group attached to HOMESIDE, a randomized controlled trial that investigated music and reading interventions for people living with dementia and their family caregivers across five countries: Australia, Germany, Norway, Poland, and the UK. The aim was to capture experiences of PPI across the five countries, explore the benefits and challenges of PPI in dementia research, and identify contributions made to the study. METHODS: We surveyed PPI members and academic researchers who collaborated on the HOMESIDE study. The survey was co-designed through consultation with PPI members and academics, alongside a small scoping literature review. Survey questions covered four topics: (1) expectations for PPI, (2) perceived contributions of PPI to the research study, (3) benefits and challenges of PPI, and (4) recommendations for future PPI in dementia research. RESULTS: There were 23 responses, representing 50% of the PPI members (n = 16) and 29% of academics (n = 7). PPI was found to be beneficial to the research and individuals involved. Contributions to the research included supporting recruitment and publicity, advising on the design of participant-facing materials, guiding the design and delivery of the interventions, and identifying cultural differences affecting research delivery. PPI members benefited from building connections, sharing experiences and receiving support, learning about dementia and research, and gaining new unexpected experiences. Academics learned about the realities of living with dementia, which they felt informed and grounded their work. Several challenges were identified, including the need for clear expectations and objectives, inconsistency of PPI members across research stages, limitations of meeting online versus in-person, scheduling difficulties, and language barriers. CONCLUSIONS: This study identifies important considerations for implementing PPI within dementia studies and international healthcare research more broadly. Our findings guided the development of five recommendations: (1) involve PPI members as early as possible and throughout the research process; (2) create a space for constructive criticism and feedback; (3) have clear tasks, roles, and expectations for PPI members; (4) involve PPI members with a diverse range of experiences and backgrounds; and (5) embed infrastructure and planning to support PPI.

Participant and Public Involvement (PPI) brings the knowledge of those with lived experience into research to improve research relevance and delivery. Our international study, called HOMESIDE, explored the benefits of music and reading activities for people with dementia and their family caregivers across five countries: Australia, Germany, Norway, Poland, and the UK. The study's PPI members included people with dementia, family carers, and healthcare professionals, who met regularly with the research team throughout the 3-year study. The current article reports the findings of a co-designed survey about PPI within HOMESIDE. Initiated by the HOMESIDE PPI members, we carried out a survey of PPI members and academics who worked on the study to learn about the unique experiences, perspectives, and contributions of PPI across the international research team.Our findings show that PPI helped to publicize the study, improved recruitment of research participants, and informed delivery of the interventions. Another important outcome was learning from each other; PPI members learned about dementia research and academics learned about the realities of living with dementia. However, the survey also highlighted challenges, including managing expectations, scheduling difficulties, and language barriers.To support PPI in future dementia research, we highlight five recommendations: (1) involve PPI members as early as possible and throughout the research process; (2) create a space for constructive criticism and feedback; (3) have clear tasks, roles, and expectations for PPI members; (4) involve PPI members with a diverse range of experiences and backgrounds; and (5) embed infrastructure and planning to support PPI.

Investigating the impact of music therapy on two in-patient psychiatric wards for people living with dementia: retrospective observational study.

BACKGROUND: Music therapy can lift mood and reduce agitation for people living with dementia (PwD) in community and residential care settings, potentially reducing the prevalence of distress behaviours. However, less is known about the impact of music therapy on in-patient psychiatric wards for PwD. AIMS: To investigate the impact of music therapy on two in-patient psychiatric wards for PwD. METHOD: A mixed-methods design was used. Statistical analysis was conducted on incidents involving behaviours reported as 'disruptive and aggressive' in 2020, when music therapy delivery varied because of the COVID-19 pandemic. Semi-structured interviews conducted online with three music therapists and eight ward-based staff were analysed using reflexive thematic analysis. RESULTS: Quantitative findings showed a significant reduction in the frequency of behaviours reported as disruptive and aggressive on days with in-person music therapy (every 14 days) than on the same weekday with no or online music therapy (every 3.3 or 3.1 days, respectively). Qualitative findings support this, with music therapy reported by music therapists and staff members to be accessible and meaningful, lifting mood and reducing agitation, with benefits potentially lasting throughout the day and affecting the ward environment. CONCLUSIONS: We identified a significant reduction in the occurrence of distress behaviours on days with in-person music therapy when compared with no music therapy. Music therapy was reported to be a valuable intervention, supporting patient mood and reducing agitation. Interventional studies are needed to investigate the impact of music therapy and its optimum mode of delivery.

Influential factors of spousal relationship quality in couples living with dementia - A narrative synthesis systematic review.

AIM: The aim of this systematic review is to identify factors that influence relationship quality in couples living with dementia. Previous research has shown how maintaining a positive spousal relationship quality is important for quality of life and coping for both the caregiver and the person with dementia. Knowledge of influential factors could contribute to a deeper understanding of the value of a couple-centred clinical practice and research, within the field of dementia. RESEARCH DESIGN AND METHODS: Systematic procedures to database search, screening, data extraction and synthesis were followed. Qualitative, quantitative and mixed methods studies were included. A narrative synthesis was conducted through narrative summaries of included studies, thematic analysis and narrative descriptions of factors influencing relationship quality. RESULTS: 39 studies were included in the study: 28 qualitative, 8 quantitative and 3 mixed methods. Through the narrative synthesis, 20 factors were identified. The factors were grouped into two overarching themes: The world of us and The world outside of us, and further to six influencing factor categories: (1) Attitudes and strategies, (2) Behaviour and activities, (3) Emotional connectedness, (4) Activities and experiences outside of the home, (5) Social behaviour and roles, and (6) Belonging and safety. DISCUSSION AND CONCLUSION: The identified factors influence relationship quality in couples living with dementia on various levels. The findings of this review study should inform clinical, couple-centred dementia care practise and intervention studies, and further research should seek to gain deeper understandings of the individual factors and broader understandings of the correlations between factors.

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.

Music therapy, neural processing, and craving reduction: an RCT protocol for a mixed methods feasibility study in a Community Substance Misuse Treatment Service.

BACKGROUND: Music therapy has been shown to be effective for multiple clinical endpoints associated with substance use disorder such as craving reduction, emotion regulation, depression, and anxiety, but there are a lack of studies investigating those effects in UK Community Substance Misuse Treatment Services (CSMTSs). Furthermore, there is a demand for identifying music therapy mechanisms of change and related brain processes for substance use disorder treatment. The present study aims to evaluate the feasibility and acceptability of music therapy and a pre-test, post-test, and in-session measurement battery in a CSMTS. METHODS: Fifteen participants, from a community service based in London, will take part in a mixed-methods non-blind randomized-controlled trial. Ten participants will receive six-weekly sessions of music therapy in addition to the standard treatment offered by the CSMTS-five of them will receive individual music therapy and five of them will receive group music therapy-while a further five participants will act as a control group receiving standard treatment only. Satisfaction and acceptability will be evaluated in focus groups with service users and staff members following the final treatment session. Moreover, attendance and completion rates will be monitored throughout the intervention. Subjective and behavioral indexes will be assessed before and after the interventions to explore the effects of music therapy on craving, substance use, symptoms of depression and anxiety, inhibitory control, and will be correlated with associated neurophysiological signatures. In-session analysis of two individual music therapy sessions will serve to explore how music and emotion are processed in the brain within the therapy. The data collected at each step will be included in an intention-to-treat analysis basis. DISCUSSION: This study will provide a first report on the feasibility of music therapy as an intervention for participants with substance use disorder engaged within a community service. It will also provide valuable information regarding the implementation of a multifaceted methodology that includes neurophysiological, questionnaire-based, and behavioral assessments in this cohort. Notwithstanding the limitation of a small sample size, the present study will provide novel preliminary data regarding neurophysiological outcomes in participants with substance use disorder that received music therapy. TRIAL REGISTRATION: ClinicalTrails.gov, NCT0518061, Registered 6 January 2022, https://clinicaltrials.gov/ct2/show/NCT05180617.

Intra- and inter-brain coupling and activity dynamics during improvisational music therapy with a person with dementia: an explorative EEG-hyperscanning single case study.

Objective: Real-life research into the underlying neural dynamics of improvisational music therapy, used with various clinical populations, is largely lacking. This single case study explored within-session differences in musical features and in within- and between-brain coupling between a Person with Dementia (PwD) and a music therapist during a music therapy session. Methods: Dual-EEG from a music therapist and a PwD (male, 31 years) was recorded. Note density, pulse clarity and synchronicity were extracted from audio-visual data. Three music therapists identified moments of interest and no interest (MOI/MONI) in two drum improvisations. The Integrative Coupling Index, reflecting time-lagged neural synchronization, and musical features were compared between the MOI and MONI. Results: Between-brain coupling of 2 Hz activity was increased during the MOI, showing anteriority of the therapist's neural activity. Within-brain coupling for the PwD was stronger from frontal and central areas during the MOI, but within-brain coupling for the therapist was stronger during MONI. Differences in musical features indicated that both acted musically more similar to one another during the MOI. Conclusion: Within-session differences in neural synchronization and musical features highlight the dynamic nature of music therapy. Significance: The findings contribute to a better understanding of social and affective processes in the brain and (interactive) musical behaviors during specific moments in a real-life music therapy session. This may provide insights into the role of such moments for relational-therapeutic processes.

The Influence of Home-Based Music Therapy Interventions on Relationship Quality in Couples Living with Dementia-An Adapted Convergent Mixed Methods Study.

Relationship quality is important for well-being and quality of life in couples living with dementia. Home-based music therapy interventions may be conducted with the aim of enhancing relationship quality. However, the effects or influences of such interventions are only briefly investigated in previous studies. This study's aim was to identify how a 12-week home-based music therapy intervention may influence relationship quality in couples living with dementia, through an adapted convergent mixed methods design. In this case, 68 participating couples from the HOMESIDE RCT study, and four individually recruited couples, received the music therapy intervention. Relationship quality for all participants was measured by the standardized Quality of Caregiver-Patient Relationship scale, and qualitative interviews were conducted with the four individually recruited participants at baseline and post intervention. Quantitative analysis indicated no statistically significant intervention effect. However, relationship quality remained stable over the intervention period. The qualitative analysis identified that the music therapy interventions primarily led to positive emotions, closeness, intimacy, and communication between the persons with dementia and their care partners. Intervention influences could also be ambiguous, as sharing music experiences might involve a risk of evoking vulnerabilities or negative emotional responses.

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

BACKGROUND: Most people with dementia live in the community, not in residential care. Therefore, quality informal care for them is critical for managing behavioural and psychological symptoms of dementia (BPSD). Music therapy has been shown to reduce BPSD. However, no randomised controlled trial has examined the effects of music interventions delivered by caregivers in home settings. The HOME-based caregiver-delivered music intervention for people living with dementia (HOMESIDE) trial aims to evaluate the effectiveness of a 12-week music intervention in addition to standard care for BPSD. This article describes the statistical analysis plan. METHODS AND ANALYSIS: HOMESIDE is a large, pragmatic international three-arm parallel-group randomised controlled trial. Dyads (persons with dementia and caregiver) in Australia, Germany, the UK, Poland and Norway were randomised to receive music and standard care, reading and standard care or standard care alone. The primary outcome is BPSD (proxy) of the person living with dementia, measured using the Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 90 and 180 days post-randomisation. Longitudinal analysis will compare NPI-Q severity between music and standard care versus standard care alone. Secondary outcomes include quality of life and depression (both person with dementia and caregiver), cognition (person with dementia only), distress, resilience, competence and caregiver-patient relationship (caregiver only). Treatment effects will be obtained at 90 and 180 days post-randomisation, where applicable. Safety outcomes (adverse events, hospitalisations, deaths) will be summarised. DISCUSSION: This statistical analysis plan provides a detailed methodology for the analysis of HOMESIDE and will improve the validity of the study and reduce the potential for bias. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001799246. Registered on November 05, 2018. CLINICALTRIALS: gov NCT03907748. Registered on April 09, 2019.

Recruitment approaches and profiles of consenting family caregivers and people living with dementia: A recruitment study within a trial.

Background: While studies have identified strategies that are useful for recruiting people living with dementia, none have focused on psychosocial interventions involving arts therapies, or have examined the profiles of older people living in the community who consent or decline participation, particularly during a global pandemic. We aimed to identify the most effective recruitment strategies according to participant characteristics and transnational differences and develop a profile of consenting and non-consenting participants. Methods: Recruitment teams in Australia, Norway, Germany, Poland, and the United Kingdom, recorded participants' source of study awareness and characteristics of consenting and non-consenting participants. Distributions of participants 'consenting to participate' were compared and logistic regressions were used to estimate the odds ratios. Results: Consenting female caregivers were disproportionally represented. Study awareness differed between countries but overall, most expressions of interest to participate were derived from referrals from professionals or organisations, or from databases of people wanting to participate in research. Troughs in recruitment rates occurred during Northern Hemisphere summer vacation periods, and during Christmas periods. Conclusions: This study found that recruiting for a trial with community-dwelling family caregivers and people living with dementia is challenging, especially during a global pandemic. While spousal caregivers comprised the highest proportion of dyads recruited, overall spousal caregivers were more reluctant to consent to participate than adult child caregivers. More targeted recruitment strategies designed for minority groups are also needed to ensure broader representation in dementia treatment studies.

Home-based family caregiver-delivered music and reading interventions for people living with dementia (HOMESIDE trial): an international randomised controlled trial.

Background: Music interventions provided by qualified therapists within residential aged care are effective at attenuating behavioural and psychological symptoms (BPSD) of people with dementia (PwD). The impact of music interventions on dementia symptom management when provided by family caregivers is unclear. Methods: We implemented a community-based, large, pragmatic, international, superiority, single-masked randomised controlled trial to evaluate if caregiver-delivered music was superior to usual care alone (UC) on reducing BPSD of PwD measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q). The study included an active control (reading). People with dementia (NPI-Q score ≥6) and their caregiver (dyads) from one of five countries were randomly allocated to caregiver-delivered music, reading, or UC with a 1:1:1 allocation stratified by site. Caregivers received three online protocolised music or reading training sessions delivered by therapists and were recommended to provide five 30-min reading or music activities per week (minimum twice weekly) over 90-days. The NPI-Q severity assessment of PwD was completed online by masked assessors at baseline, 90- (primary) and 180-days post-randomisation and analysed on an intention-to-treat basis using a likelihood-based longitudinal data analysis model. ACTRN12618001799246; ClinicalTrials.govNCT03907748. Findings: Between 27th November 2019 and 7th July 2022, we randomised 432 eligible of 805 screened dyads (music n = 143, reading n = 144, UC n = 145). There was no statistical or clinically important difference in the change from baseline BPSD between caregiver-delivered music (-0.15, 95% CI -1.41 to 1.10, p = 0.81) or reading (-1.12, 95% CI -2.38 to 0.14, p = 0.082) and UC alone at 90-days. No related adverse events occurred. Interpretation: Our findings suggested that music interventions and reading interventions delivered by trained caregivers in community contexts do not decrease enduring BPSD symptoms. Funding: Our funding was provided by National Health and Medical Research Council, Australia; The Research Council of Norway; Federal Ministry of Education and Research, Germany; National Centre for Research and Development, Poland; Alzheimer's Society, UK, as part of the Joint Programme for Neurodegenerative Diseases consortia scheme.

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.

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.

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.