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.

Music-based therapeutic interventions for people with dementia.

BACKGROUND: Dementia is a clinical syndrome with a number of different causes which is characterised by deterioration in cognitive, behavioural, social and emotional functions. Pharmacological interventions are available but have limited effect to treat many of the syndrome's features. Less research has been directed towards non-pharmacological treatments. In this review, we examined the evidence for effects of music-based interventions. OBJECTIVES: To assess the effects of music-based therapeutic interventions for people with dementia on emotional well-being including quality of life, mood disturbance or negative affect, behavioural problems, social behaviour and cognition at the end of therapy and four or more weeks after the end of treatment. SEARCH METHODS: We searched ALOIS, the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG) on 19 June 2017 using the terms: music therapy, music, singing, sing, auditory stimulation. Additional searches were carried out on 19 June 2017 in the major healthcare databases MEDLINE, Embase, PsycINFO, CINAHL and LILACS; and in trial registers and grey literature sources. SELECTION CRITERIA: We included randomised controlled trials of music-based therapeutic interventions (at least five sessions) for people with dementia that measured any of our outcomes of interest. Control groups either received usual care or other activities with or without music. DATA COLLECTION AND ANALYSIS: Two review authors worked independently to screen the retrieved studies against the inclusion criteria and then to extract data and assess methodological quality of the included studies. If necessary, we contacted trial authors to ask for additional data, including relevant subscales, or for other missing information. We pooled data using random-effects models. MAIN RESULTS: We included 22 studies with 1097 randomised participants. Twenty-one studies with 890 participants contributed data to meta-analyses. Participants in the studies had dementia of varying degrees of severity, and all were resident in institutions. Seven studies delivered an individual music intervention; the other studies delivered the intervention to groups of participants. Most interventions involved both active and receptive musical elements. The methodological quality of the studies varied. All were at high risk of performance bias and some were at high risk of detection or other bias.At the end of treatment, we found low-quality evidence that the interventions may improve emotional well-being and quality of life (standardised mean difference (SMD) 0.32, 95% confidence interval (CI) 0.02 to 0.62; 9 studies, 348 participants) and reduce anxiety (SMD -0.43, 95% CI -0.72 to -0.14; 13 studies, 478 participants). We found low-quality evidence that music-based therapeutic interventions may have little or no effect on cognition (SMD 0.15, 95% CI -0.06 to 0.36; 7 studies, 350 participants). There was moderate-quality evidence that the interventions reduce depressive symptoms (SMD -0.27, 95% CI -0.45 to -0.09; 11 studies, 503 participants) and overall behaviour problems (SMD -0.23, 95% CI -0.46 to -0.01; 10 studies, 442 participants), but do not decrease agitation or aggression (SMD -0.07, 95% CI -0.24 to 0.10; 14 studies, 626 participants). The quality of the evidence on social behaviour was very low, so effects were very uncertain.The evidence for long-term outcomes measured four or more weeks after the end of treatment was of very low quality for anxiety and social behaviour, and for the other outcomes, it was of low quality for little or no effect (with small SMDs, between 0.03 and 0.34). AUTHORS' CONCLUSIONS: Providing people with dementia who are in institutional care with at least five sessions of a music-based therapeutic intervention probably reduces depressive symptoms and improves overall behavioural problems at the end of treatment. It may also improve emotional well-being and quality of life and reduce anxiety, but may have little or no effect on agitation or aggression or on cognition. We are uncertain about effects on social behaviour and about long-term effects. Future studies should examine the duration of effects in relation to the overall duration of treatment and the number of sessions.

Music therapy for depression.

BACKGROUND: Depression is a highly prevalent mood disorder that is characterised by persistent low mood, diminished interest, and loss of pleasure. Music therapy may be helpful in modulating moods and emotions. An update of the 2008 Cochrane review was needed to improve knowledge on effects of music therapy for depression. OBJECTIVES: 1. To assess effects of music therapy for depression in people of any age compared with treatment as usual (TAU) and psychological, pharmacological, and/or other therapies.2. To compare effects of different forms of music therapy for people of any age with a diagnosis of depression. SEARCH METHODS: We searched the following databases: the Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR; from inception to 6 May 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; to 17 June 2016); Thomson Reuters/Web of Science (to 21 June 2016); Ebsco/PsycInfo, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, and PubMed (to 5 July 2016); the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, the National Guideline Clearing House, and OpenGrey (to 6 September 2016); and the Digital Access to Research Theses (DART)-Europe E-theses Portal, Open Access Theses and Dissertations, and ProQuest Dissertations and Theses Database (to 7 September 2016). We checked reference lists of retrieved articles and relevant systematic reviews and contacted trialists and subject experts for additional information when needed. We updated this search in August 2017 and placed potentially relevant studies in the "Awaiting classification" section; we will incorporate these into the next version of this review as appropriate. SELECTION CRITERIA: All randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing music therapy versus treatment as usual (TAU), psychological therapies, pharmacological therapies, other therapies, or different forms of music therapy for reducing depression. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated standardised mean difference (SMD) for continuous data and odds ratio (OR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic. MAIN RESULTS: We included in this review nine studies involving a total of 421 participants, 411 of whom were included in the meta-analysis examining short-term effects of music therapy for depression. Concerning primary outcomes, we found moderate-quality evidence of large effects favouring music therapy and TAU over TAU alone for both clinician-rated depressive symptoms (SMD -0.98, 95% CI -1.69 to -0.27, 3 RCTs, 1 CCT, n = 219) and patient-reported depressive symptoms (SMD -0.85, 95% CI -1.37 to -0.34, 3 RCTs, 1 CCT, n = 142). Music therapy was not associated with more or fewer adverse events than TAU. Regarding secondary outcomes, music therapy plus TAU was superior to TAU alone for anxiety and functioning. Music therapy and TAU was not more effective than TAU alone for improved quality of life (SMD 0.32, 95% CI -0.17 to 0.80, P = 0.20, n = 67, low-quality evidence). We found no significant discrepancies in the numbers of participants who left the study early (OR 0.49, 95% CI 0.14 to 1.70, P = 0.26, 5 RCTs, 1 CCT, n = 293, moderate-quality evidence). Findings of the present meta-analysis indicate that music therapy added to TAU provides short-term beneficial effects for people with depression if compared to TAU alone. Additionally, we are uncertain about the effects of music therapy versus psychological therapies on clinician-rated depression (SMD -0.78, 95% CI -2.36 to 0.81, 1 RCT, n = 11, very low-quality evidence), patient-reported depressive symptoms (SMD -1.28, 95% CI -3.75 to 1.02, 4 RCTs, n = 131, low-quality evidence), quality of life (SMD -1.31, 95% CI - 0.36 to 2.99, 1 RCT, n = 11, very low-quality evidence), and leaving the study early (OR 0.17, 95% CI 0.02 to 1.49, 4 RCTs, n = 157, moderate-quality evidence). We found no eligible evidence addressing adverse events, functioning, and anxiety. We do not know whether one form of music therapy is better than another for clinician-rated depressive symptoms (SMD -0.52, 95% CI -1.87 to 0.83, 1 RCT, n = 9, very low-quality evidence), patient-reported depressive symptoms (SMD -0.01, 95% CI -1.33 to 1.30, 1 RCT, n = 9, very low-quality evidence), quality of life (SMD -0.24, 95% CI -1.57 to 1.08, 1 RCT, n = 9, very low-quality evidence), or leaving the study early (OR 0.27, 95% CI 0.01 to 8.46, 1 RCT, n = 10). We found no eligible evidence addressing adverse events, functioning, or anxiety. AUTHORS' CONCLUSIONS: Findings of the present meta-analysis indicate that music therapy provides short-term beneficial effects for people with depression. Music therapy added to treatment as usual (TAU) seems to improve depressive symptoms compared with TAU alone. Additionally, music therapy plus TAU is not associated with more or fewer adverse events than TAU alone. Music therapy also shows efficacy in decreasing anxiety levels and improving functioning of depressed individuals.Future trials based on adequate design and larger samples of children and adolescents are needed to consolidate our findings. Researchers should consider investigating mechanisms of music therapy for depression. It is important to clearly describe music therapy, TAU, the comparator condition, and the profession of the person who delivers the intervention, for reproducibility and comparison purposes.

Music-based therapeutic interventions for people with dementia.

BACKGROUND: Dementia is a clinical syndrome with a number of different causes which is characterised by deterioration in cognitive, behavioural, social and emotional functions. Pharmacological interventions are available but have limited effect to treat many of the syndrome's features. Less research has been directed towards non-pharmacological treatments. In this review, we examined the evidence for effects of music-based interventions as a treatment. OBJECTIVES: To assess the effects of music-based therapeutic interventions for people with dementia on emotional well-being including quality of life, mood disturbance or negative affect, behavioural problems, social behaviour, and cognition at the end of therapy and four or more weeks after the end of treatment. SEARCH METHODS: We searched ALOIS, the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG) on 14 April 2010 using the terms: music therapy, music, singing, sing, auditory stimulation. Additional searches were also carried out on 3 July 2015 in the major healthcare databases MEDLINE, Embase, psycINFO, CINAHL and LILACS; and in trial registers and grey literature sources. On 12 April 2016, we searched the major databases for new studies for future evaluation. SELECTION CRITERIA: We included randomized controlled trials of music-based therapeutic interventions (at least five sessions) for people with dementia that measured any of our outcomes of interest. Control groups either received usual care or other activities. DATA COLLECTION AND ANALYSIS: Two reviewers worked independently to screen the retrieved studies against the inclusion criteria and then to extract data and assess methodological quality of the included studies. If necessary, we contacted trial authors to ask for additional data, including relevant subscales, or for other missing information. We pooled data using random-effects models. MAIN RESULTS: We included 17 studies. Sixteen studies with a total of 620 participants contributed data to meta-analyses. Participants in the studies had dementia of varying degrees of severity, but all were resident in institutions. Five studies delivered an individual music intervention; in the others, the intervention was delivered to groups of participants. Most interventions involved both active and receptive musical elements. The methodological quality of the studies varied. All were at high risk of performance bias and some were at high risk of detection or other bias. At the end of treatment, we found low-quality evidence that music-based therapeutic interventions may have little or no effect on emotional well-being and quality of life (standardized mean difference, SMD 0.32, 95% CI -0.08 to 0.71; 6 studies, 181 participants), overall behaviour problems (SMD -0.20, 95% CI -0.56 to 0.17; 6 studies, 209 participants) and cognition (SMD 0.21, 95% CI -0.04 to 0.45; 6 studies, 257 participants). We found moderate-quality evidence that they reduce depressive symptoms (SMD -0.28, 95% CI -0.48 to -0.07; 9 studies, 376 participants), but do not decrease agitation or aggression (SMD -0.08, 95% CI -0.29 to 0.14; 12 studies, 515 participants). The quality of the evidence on anxiety and social behaviour was very low, so effects were very uncertain. The evidence for all long-term outcomes was also of very low quality. AUTHORS' CONCLUSIONS: Providing people with dementia with at least five sessions of a music-based therapeutic intervention probably reduces depressive symptoms but has little or no effect on agitation or aggression. There may also be little or no effect on emotional well-being or quality of life, overall behavioural problems and cognition. We are uncertain about effects on anxiety or social behaviour, and about any long-term effects. Future studies should employ larger sample sizes, and include all important outcomes, in particular 'positive' outcomes such as emotional well-being and social outcomes. Future studies should also examine the duration of effects in relation to the overall duration of treatment and the number of sessions.