Waldorff 2012

Methods	RCT Multicentre rater‐blinded trial 1:1 randomisation Treatment as usual beyond the level of usual care
Participants	N = 330 (151M, 179F) Clinical diagnosis of dementia using DSM‐IV and NINCDS‐ADRDA or McKeith criteria Patients with mild recently diagnosed dementia Mean age = 76.2 Living in the community, age ≥ 50 years with MMSE ≥ 20 Recruited only patients receiving a conventional diagnostic evaluation by specialists Excluded: Participants with severe somatic or psychiatric comorbidity, participating in other interventions, living in nursing home at baseline, or having frontotemporal dementia
Interventions	Mutlifaceted and semi‐tailored intervention consisting of counselling sessions, teaching, education and outreach telephone support to patients and carers Provided individually and as a group intervention Duration of intervention 8 to 12 months Control group was provided with overall information and guidance, and was directed towards local support programmes (provided to both the control and treatment group)
Outcomes	Patient Outcomes Depression: Cornell Scale for Depression in Dementia (CSDD) Other behavioral outcomes: EuroQoL VAS (patient and proxy rated) (EQ‐VAS) Quality of Life in Alzheimer's Disease (patient and proxy rated) (QoL‐AD) Neuropsychiatric Inventory Questionnaire (NPI‐Q) Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale (ADSC‐ADL) Cognitive function: Mini Mental State Examination (MMSE) Caregiver outcomes: Geriatric Depression Scale (GDS) EuroQoL VAS (Quality of Life) (EQ‐VAS) Outcomes measured at 6 months and at 12 months
Notes	Intervention consisted of 6 or 7 counselling sessions, 5 educational courses, 5‐8 telephone calls within a 3‐ to 4‐week intervals approximately DSM‐IV ‐ Diagnostic and Statistical Manual of Mental Disorders, 4th edition NINCDS‐ADRDA ‐ National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was performed using a computer programme
Allocation concealment (selection bias)	Low risk	Central allocation process was used to randomise participants by a third party
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Raters were not employed by the same institution as study coordinators and counsellors
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Raters were blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	Information on attrition and reasons provided, authors mention use of intention‐to‐treat analyses
Selective reporting (reporting bias)	Low risk	All outcomes specified were reported
Other bias	Low risk	No other apparent bias