Cohen‐Mansfield 2012a.

Methods	Cluster‐randomised controlled trial; registration number: NCT00820859 Duration of follow‐up: 10 consecutive days Conducted between June 2006 and December 2011
Participants	Country: USA Participants were recruited from 11 nursing homes (n = 6 intervention group, n = 5 control group), in Rockville, Silver Spring, Takoma Park, Chevy Chase, and Gaithersburg, Maryland, USA. Inclusion criteria: all residents of the participating clusters with a diagnosis of dementia, at age ≥ 60 years, who lived in the facility for more than 3 weeks and exhibited agitation several times per day Exclusion criteria: residents with a diagnosis of bipolar disorder or schizophrenia, an MMSE score ≥ 25, manifested aggressive behaviours, or took part in earlier studies testing a TREA intervention Number of participants completing the study: n = 125 (intervention group n = 89, control group n = 36) Age (mean ± SD) years: intervention group 85.9 ± 8.62, control group 85.3 ± 9.62 Gender, female: intervention group 73%, control group 77.8% Cognitive status, MMSE (mean ± SD): intervention group 7.62 ± 6.33, control group 9.38 ± 6.76 Care dependency, ADL performance (from Minimum Data Set (MDS), 0 (independent) to 4 (total dependence)) (mean ± SD): intervention group 2.72 ± 0.84, control group 2.75 ± 0.98
Interventions	Intervention: activity programme based on the Treatment Routes for Exploring Agitation (TREA) framework Control: presentation for nursing staff describing the syndromes of agitation, their aetiologies, and possible non‐pharmacologic interventions
Outcomes	Primary: agitation (ABMI) Secondary: affect (pleasure, interest, anger, anxiety, sadness) (LMBS)
Funding	National Institutes of Health; USA
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization to intervention or placebo control protocols was performed using random numbers via a ratio of 1.5: 1, with the intent of having more intervention than control participants in order to investigate process issues."
Allocation concealment (selection bias)	Unclear risk	No methods for allocation concealment were reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	"The research assistants who gathered initial baseline data were blind to the group allocation of residents; of course, once treatment started, research assistants were no longer blinded to group assignment." "Study participants were blinded as to their group assignment"; comment: since the control group did not receive an active control intervention, blinding of participants seems not possible.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Research assistants could not be blinded once interventions began."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Residents not included after cluster randomisation: "Placebo (n = 36), bipolar disorder or schizophrenia diagnosis (n = 3), not agitated (n = 25), age < 60 years (n = 3), death(n = 2), participated in previous TREA study (n = 2), gave consent but could not be included before the data collection phase ended (n = 1). Intervention (n = 62), bipolar disorder or schizophrenia diagnosis (n = 6), not agitated (n = 29), age < 60 years (n = 3), MMSE > 25 (n = 2), no diagnosis of dementia (n = 1), death (n = 13), discharged (n = 6), life expectancy < 3 months (n = 1), gave consent but could not be included before the data collection phase ended (n = 1)" "Did not receive placebo as allocated (n = 4, lost to death), did not receive intervention as allocated (n = 4, lost to death)"
Selective reporting (reporting bias)	Unclear risk	All outcomes reported, but the study was registered retrospectively and no study protocol is available.
Other bias	High risk	Cluster effect was not incorporated in the analysis (unit‐of‐analysis bias).