Stanley 2012

Methods	RCT (randomisation in blocks of 4 or 6 stratified by CDR scores ‐ 0.5, 1., or 2., completed in SAS)
Participants	n = 32 (13M, 19F) Inclusion criteria 1) diagnosis of dementia (confirmed by the patient’s medical provider) 2) an NPI‐A ≥ 4 3) CDR score of 0.5 to 2.0 Exclusion criteria Ps with a primary psychiatric diagnosis of major depression, active psychosis, bipolar disorder, active suicidal intent, recent verbal or physical aggression   Dementia diagnosis AD (62.5%), DLB (3.1%), VaD (9.4%) and 25.0% dementia not otherwise specified (NOS) Principal DSM‐IV Diagnoses 43.8% had a diagnosis of GAD, 18.8% a diagnosis of other anxiety disorder, 43.8% comorbid anxiety and depression, 34.4% no diagnosis and 3.1% a depression diagnosis. A total of 46.9% of the sample scored a CDR of 0.5 or 1, and 75% were on at least one psychotropic medication
Interventions	A cognitive–behavioral therapy–based intervention for anxiety in dementia, of 12 weekly in‐home based sessions and brief telephone sessions, involving self‐monitoring for anxiety, deep breathing, and optional skills (coping self‐statements, behavioral activation, and sleep management). Carers were involved as coaches. Additional materials were provided on communication, education of dementia and stress reduction for collaterals Control group receives usual care incorporating diagnostic feedback
Outcomes	Patient outcomes Depression: Geriatric Depression Scale (GDS) self report Anxiety: Neuropsychiatric Inventory–Anxiety (NPI‐A) subscale (collateral anxiety report) Rating Anxiety in Dementia (RAID) (administered as a clinical interview to the patient and the caregiver) Geriatric Anxiety Inventory (GAI) self report Worry: Penn State Worry Questionnaire–Abbreviated (PSWQ‐A) self report Quality of Life: Quality of Life in Alzheimer disease (QOL‐AD) Carer Outcomes Depression: Patient Health Questionnaire (PHQ‐9) Distress: distress item from the NPI‐A
Notes	Peaceful Mind was provided by two master’s‐level graduate‐student clinicians and a predoctoral intern supervised by clinical psychologists and a geriatric social worker. A total of 12 weekly in‐home sessions were provided and up to 8 brief telephone sessions, for 6 months, with each session lasting 30 to 60 minutes. AD ‐ Alzheimer's disease DLB ‐ Dementia with Lewy bodies VaD ‐ Vascular Dementia GAD ‐ General Anxiety Disorder
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The author communicated that randomisation was completed in blocks of four or six stratified by CDR (Clinical Dementia Rating scores), in SAS
Allocation concealment (selection bias)	Unclear risk	No details of method of concealment described to allow judgment
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information is provided
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All outcome measures were administered in‐person by independent evaluators who were unaware of treatment assignment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition and reasons reported, intention‐to treat analyses
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes reported
Other bias	Low risk	No other apparent bias