Link-me: Protocol for a randomised controlled trial of a systematic approach to stepped mental health care in primary care.

Primary care in Australia is undergoing significant reform, with a particular focus on cost-effective tailoring of mental health care to individual needs. Link-me is testing whether a patient-completed Decision Support Tool (DST), which predicts future severity of depression and anxiety symptoms and triages individuals into care accordingly, is clinically effective and cost-effective relative to usual care. The trial is set in general practices, with English-speaking patients invited to complete eligibility screening in their general practitioner's waiting room. Eligible and consenting patients will then complete the DST assessment and are randomised and stratified according to predicted symptom severity. Participants allocated to the intervention arm will receive feedback on DST responses, select treatment priorities, assess motivation to change, and receive a severity-matched treatment recommendation (information about and links to low intensity services for those with mild symptoms, or assistance from a specially trained health professional (care navigator) for those with severe symptoms). All patients allocated to the comparison arm will receive usual GP care plus attention control. Primary (psychological distress) and secondary (depression, anxiety, quality of life, days out of role) outcomes will be assessed at 6 and 12 months. Differences in outcome means between trial arms both across and within symptom severity group will be examined using intention-to-treat analyses. Within trial and modelled economic evaluations will be conducted to determine the value for money of credentials of Link-me. Findings will be reported to the Federal Government to inform how mental health services across Australia are funded and delivered in the future.