Raglio 2010a

Methods	RCT (parallel). Study duration or start and end dates not reported.
Participants	Country: Italy. N = 20 residents of a nursing home, of whom 15 were female (8/10 in the experimental group and 7/10 in the control group). Mean age was 84 (SD 6) for the experimental group, and 87 (SD 6) in the control group. The participants had Alzheimer's disease according to NINCDS‐ADRDA criteria or vascular dementia according to NINDS‐AIREN criteria. Clinical Dementia Rating (CDR) scale means were 1.9 (SD 0.9) in the music therapy group, and 2.2 (SD 0.7) in control group. Mean Mini‐Mental State Examination (MMSE) scores at baseline were 17 ± 6, and 13 ± 4, respectively. "Patients with musical competence or knowledge about music therapy were excluded".
Interventions	1) Active, individual music therapy intervention in which free musical improvisation is used to build a relationship between participant and music therapist; 30 sessions of 30 minutes, twice a week (during 15 weeks). 2) Control group with no music exposure but educational and occupational activities such as personal care, lunch, bath, cognitive stimulation reading a newspaper etc. Frequency or duration is not reported, and these activities are referred to as "standard care".
Outcomes	1) Main outcome (in line with study aims): behavioural and psychological symptoms of dementia measured with the Neuropsychiatric Inventory (NPI; no timeframe reported but reference provided), including depression subscore 2) Other outcomes were cognition, measured with the MMSE and the Alzheimer's Disease Assessment Scale cognitive sub scale (ADAS‐cog), and depression measured with the NPI. Heart rate (variability) and (I)ADL were outcomes as well.
Notes	Funding source not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Software mentioned: “patients were randomised to music therapy treatment or standard care by using the randomisation program QuickCalcs”.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible to blind the convener and participants.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not clear who assessed the outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropout.
Selective reporting (reporting bias)	Unclear risk	No protocol of the (pilot) study available.
Other bias	Low risk