Dias 2008.

Study characteristics
Methods	Study design: RCT Duration of study: the study was conducted between 2015 and 2017. Country: India Income classification: lower‐middle‐income country in 2015 to 2017 Geographical scope: 2 semi‐urban administrative areas (Talukas) in Goa Healthcare setting: home
Participants	1. Age: carers around 53 years; patients with dementia around 78 years 2. Gender: both 3. Socioeconomic background: not specified 4. Educational background: 40% of patients with dementia and 20% of carers had below primary education. Most (90%) were unable to afford paid help. Inclusion criteria: a. all probable cases will be examined by a trained clinician (AD) to confirm the diagnosis of dementia according to DSM‐IV criteria and graded using the Clinical Dementia Rating (CDR) Scale; b. CDR mild and moderate dementia; c. the principal caregiver, as identified by the family, was enrolled for the trial. The principal caregiver was generally the spouse, although in some instances another family member was the principal caregiver, particularly when the spouse was not in a position to care. Exclusion criteria: CDR severe dementia or severe comorbid physical health conditions. Note: at baseline, the intervention and control group scores for General Health Questionnaire (GHQ‐12) were, respectively, 4 (2.8) and 2.50 (2.3). Stated purpose: to develop and evaluate the effectiveness of a home‐based intervention in reducing caregiver burden, promoting caregiver mental health, and reducing behavioural problems in elderly persons with dementia
Interventions	Name: 10/66 flexible stepped‐care brief carer intervention Title/name of PW and number: healthcare assistants (HCA)s, 2 in each taluk), and 1 lay health counsellor (LC), shared by both taluks (5 in total) 1. Selection: HCA: knowledge of the local language, being literate, motivated to involve in community care of older people. LC: she was part of the intervention team/authors; member of the Dementia Society in Goa. 2. Educational background: HCA: passed the higher secondary school, LC: not specified. 3. Training: HCA: intensive training module over 1 week developed/adapted to local settings. Trained in key skills including listening and counselling skills, bereavement counselling, stress management, and health advice for common health problems. Trained by the author (geriatrician/epidemiologist) and LHC. LHC: not specified. 4. Supervision: meetings every 2 weeks with psychiatrist and LC. The HCA would meet the psychiatrist twice a month to give updates on the person with dementia, especially if they were taking medication. In addition, met with the LC every 2 weeks to share experiences, support one another, and problem‐solve difficult situations. LC: supervised by the psychiatrists. 5. Incentives/remuneration: LC, Rs 5000/month. HCA, not specified. Prevention type: selective – caregivers of people with dementia who presented baseline levels of distress well below the cut‐off used in the literature for the measure Intervention details: home visits at least every 2 weeks for 6 months. HCAs: Intervention for carers: psychoeducation plus follow‐up and some counselling skills. Patients or carers (or both) had a follow‐up with the psychiatrist, and patients may be prescribed medication. Control: waiting list – control arm dyads received only education and information regarding dementia and were then placed on a waiting list to receive the intervention after 6 months. Both intervention and control were free to utilize existing health services during this time.
Outcomes	Participants’outcomes of interest for this review Depressive symptoms – GHQ‐12 Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (1‐6 months)
Notes	Source of funding: World Health Organization Notes on validation of instruments (screening and outcomes): all these instruments were translated into Konkani, the local language of Goa, using standard methods of translation and back‐translation. These instruments have been used in India for the 10/66 caregiver studies. Additional information: none Handling the data: not applicable Prospective trial registration number: NCT00479271