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.

Adaptive Elements in Internet-Delivered Psychological Treatment Systems: Systematic Review.

BACKGROUND: Internet-delivered psychological treatments (IDPTs) are built on evidence-based psychological treatment models, such as cognitive behavioral therapy, and are adjusted for internet use. The use of internet technologies has the potential to increase access to evidence-based mental health services for a larger proportion of the population with the use of fewer resources. However, despite extensive evidence that internet interventions can be effective in the treatment of mental health disorders, user adherence to such internet intervention is suboptimal. OBJECTIVE: This review aimed to (1) inspect and identify the adaptive elements of IDPT for mental health disorders, (2) examine how system adaptation influences the efficacy of IDPT on mental health treatments, (3) identify the information architecture, adaptive dimensions, and strategies for implementing these interventions for mental illness, and (4) use the findings to create a conceptual framework that provides better user adherence and adaptiveness in IDPT for mental health issues. METHODS: The review followed the guidelines from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The research databases Medline (PubMed), ACM Digital Library, PsycINFO, CINAHL, and Cochrane were searched for studies dating from January 2000 to January 2020. Based on predetermined selection criteria, data from eligible studies were analyzed. RESULTS: A total of 3341 studies were initially identified based on the inclusion criteria. Following a review of the title, abstract, and full text, 31 studies that fulfilled the inclusion criteria were selected, most of which described attempts to tailor interventions for mental health disorders. The most common adaptive elements were feedback messages to patients from therapists and intervention content. However, how these elements contribute to the efficacy of IDPT in mental health were not reported. The most common information architecture used by studies was tunnel-based, although a number of studies did not report the choice of information architecture used. Rule-based strategies were the most common adaptive strategies used by these studies. All of the studies were broadly grouped into two adaptive dimensions based on user preferences or using performance measures, such as psychometric tests. CONCLUSIONS: Several studies suggest that adaptive IDPT has the potential to enhance intervention outcomes and increase user adherence. There is a lack of studies reporting design elements, adaptive elements, and adaptive strategies in IDPT systems. Hence, focused research on adaptive IDPT systems and clinical trials to assess their effectiveness are needed.

Usability Evaluations of Mobile Mental Health Technologies: Systematic Review.

BACKGROUND: Many mobile health (mHealth) apps for mental health have been made available in recent years. Although there is reason to be optimistic about their effect on improving health and increasing access to care, there is a call for more knowledge concerning how mHealth apps are used in practice. OBJECTIVE: This study aimed to review the literature on how usability is being addressed and measured in mHealth interventions for mental health problems. METHODS: We conducted a systematic literature review through a search for peer-reviewed studies published between 2001 and 2018 in the following electronic databases: EMBASE, CINAHL, PsycINFO, PubMed, and Web of Science. Two reviewers independently assessed all abstracts against the inclusion and exclusion criteria, following the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. RESULTS: A total of 299 studies were initially identified based on the inclusion keywords. Following a review of the title, abstract, and full text, 42 studies were found that fulfilled the criteria, most of which evaluated usability with patients (n=29) and health care providers (n=11) as opposed to healthy users (n=8) and were directed at a wide variety of mental health problems (n=24). Half of the studies set out to evaluate usability (n=21), and the remainder focused on feasibility (n=10) or acceptability (n=10). Regarding the maturity of the evaluated systems, most were either prototypes or previously tested versions of the technology, and the studies included few accounts of sketching and participatory design processes. The most common reason referred to for developing mobile mental health apps was the availability of mobile devices to users, their popularity, and how people in general became accustomed to using them for various purposes. CONCLUSIONS: This study provides a detailed account of how evidence of usability of mHealth apps is gathered in the form of usability evaluations from the perspective of computer science and human-computer interaction, including how users feature in the evaluation, how the study objectives and outcomes are stated, which research methods and techniques are used, and what the notion of mobility features is for mHealth apps. Most studies described their methods as trials, gathered data from a small sample size, and carried out a summative evaluation using a single questionnaire, which indicates that usability evaluation was not the main focus. As many studies described using an adapted version of a standard usability questionnaire, there may be a need for developing a standardized mHealth usability questionnaire.

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.