Objectives: Dementia is a rapidly growing public health problem in low and middle income countries. There is an urgent need, in the absence of formal services, to develop interventions designed to improve the lives of people with dementia, and their families. This study tests the effectiveness of the 10/66 caregiver intervention among people with dementia, and their carers.

Design: A single blind parallel group randomized controlled trial (ISRCTN41039907).

Setting: Moscow.

Participants: Sixty family caregivers of people aged 65 and over with dementia were randomized to receive the intervention and medical care as usual (n = 30) or medical care as usual only (n = 30). Caregiver and person with dementia outcomes were assessed at baseline and after 6 months.

Intervention: The caregiver education and training intervention was delivered over five, weekly, half-hour sessions and was made up of three modules: (i) assessment (one session); (ii) basic education about dementia (two sessions); and (iii) training regarding specific problem behaviors (two sessions).

Measurements: Dementia was diagnosed using DSM-IV criteria. Caregiver: Zarit Carer Burden Interview; carer psychological distress (SRQ 20); and carer Quality of Life (WHOQOL-BREF). Person with dementia: Behavioural and Psychological symptoms (NPI-Q); quality of life (DEMQOL).

Results: Caregivers in the intervention group reported large and statistically significant net improvements at 6-month follow-up in burden compared to controls. No group differences were found on caregiver psychological distress and patient and caregiver quality of life.

Conclusions: The low-level intervention seems to be as, if not more, effective than similar interventions applied in high income countries.