Gonyea 2006.

Methods	Randomised controlled trial. Study duration: 6 weeks.
Participants	80 caregivers (CG) with a mean age of 64.4 years, providing a weekly minimum of 4 hours care to 80 care recipients (CR) with a confirmed diagnosis of Alzheimer’s disease (mean age: 77) in the mild to moderate severity range, with at least one neuropsychiatric symptom. Caregivers were mostly spouses, female and Caucasian.
Interventions	Caregiver group based training intervention (Project CARE) Psychoeducational control group using similar structure to the intervention group. Primary aim: CG distress associated with CR behaviour, CG burden and CR behaviour problems. (See Table 2)
Outcomes	Neuropsychiatric inventory (NPI) ‐ Severity & Distress Zarit Burden Interview (ZBI) (See Table 3)
Notes	Country of origin: Boston, USA. Caregiver based multi‐component behavioural group intervention, delivered over 5‐weekly 90 minute sessions with 15 minutes individual time. The intervention was delivered in a group format (5 ‐10 members). The intervention was based on the principles of behaviour therapy and activation and designed to teach behavioural techniques for managing care recipients neuropsychiatric symptoms in the home environment. Caregivers were taught ABC behavioural analysis. The control group had a similar structure to the intervention, but consisted of only general information on aging and Alzheimer’s disease, home safety, support and techniques for improved communication. The total study duration was 6 weeks.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	'We then assigned participants by block randomisation'
Allocation concealment (selection bias)	Low risk	'We assigned participants by block randomisation to one of the two conditions'. Unclear as to who performed the randomisation.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Therapists had 16‐20 hours training in intervention protocols. To monitor treatment fidelity, PI consulted with therapists on a regular basis to review group sessions and assess group progress. Not all caregivers adhered to the intervention (did not submit homework).
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Reported in the discussion 'It was also not possible to blind all interviewers to the caregivers treatment condition at the post‐intervention assessment'
Incomplete outcome data (attrition bias) All outcomes	Low risk	Specific reasons for withdrawal not reported; however, the number withdrawn is recorded. (11 caregivers did not complete)
Selective reporting (reporting bias)	Unclear risk	NPI frequency not reported, only severity.
Other bias	Unclear risk	Generalisabilty to the general population difficult due to low numbers of ethnically and racially diverse individuals.