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Link-me: A randomised controlled trial of a systematic model of stepped mental health care in general practice

Link-me: A randomised controlled trial of the effectiveness of a systematic approach to stepped mental health care in improving psychological distress among general practice patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001333303
Enrollment
2100
Registered
2017-09-19
Start date
2017-11-21
Completion date
2018-10-31
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

1 in 2 Australians will experience mental health problems in their lifetime. Mental health problems can make it hard for people to live the life they want. Lots of things can help improve mental health, but it can be hard for people to know what is the best option for them. Link-me is a randomised controlled trial that is testing a new approach to helping people find support that works for them. It is funded by the Australian Government and is being conducted by researchers at the University of Melbourne. Link-me builds on almost 15 years of research in Australian general practice. This research has shown that about one third of people attending a general practice are experiencing difficulties with their mental health. GPs currently have no systematic way of identifying the best way to tailor mental health care to each individual’s needs. In this trial, we aim to address this gap and determine whether a simple, purpose-built online tool can improve mental health outcomes in a cost-effective way. Using the tool, GP patients can: - complete an assessment - receive feedback on their results - set priorities based on these results - receive a suggested treatment option matched to their risk of future mental health problems. Reception staff at participating general practices will invite patients to complete a 2-minute survey on an iPad before they see their GP. Whether or not someone completes the survey is entirely up to them. The survey identifies whether or not a person is eligible for the trial – if so, they are invited to read the study information and provide informed consent to take part. People who are interested in participating then answer a few more questions on the iPad. The questions take about 2 minutes to answer and at the end, the iPad will randomly allocate people to one of two groups. Each group will provide us with different information about managing mental health and wellbeing. Some people will be asked for feedback on how mental health is currently managed, others might be asked to try something different (like using the internet or working with their GP clinic to find other options). People taking part in Link-me will be contacted 6, 12, and 18 months after they complete the iPad questions in their GP waiting room to complete short online surveys. Answering these surveys will help us understand whether the Link-me approach to care can help people improve their mental health. Taking part in Link-me is completely voluntary and people who do decide to take part can change their mind at any time.

Interventions

The intervention being tested in this trial is multifaceted and includes: 1. Estimating future symptom severity using a Decision Support Tool (DST) developed by our team using findings from our naturalistic longitudinal cohort study of depression in Australian primary care (the diamond study). Using an individual’s responses to the DST, he or she will be stratified into either the minimal/mild or severe/complex group, based on predicted severity of mental health problem in 3 months’ time. 2. Fe

The intervention being tested in this trial is multifaceted and includes: 1. Estimating future symptom severity using a Decision Support Tool (DST) developed by our team using findings from our naturalistic longitudinal cohort study of depression in Australian primary care (the diamond study). Using an individual’s responses to the DST, he or she will be stratified into either the minimal/mild or severe/complex group, based on predicted severity of mental health problem in 3 months’ time. 2. Feedback to participants on their DST responses: "From what you have told us, things seem to be ok for you in these areas right now" and "Things seem to be difficult for you in these areas right now", presented on sequential screens 3. An opportunity to set priorities: If the participant has many areas that are identified as being difficult, he/she is encouraged to select one or two to focus on. 4. A treatment recommendation matched to severity group (minimal/mild or severe/complex), detailed below. Note that all patients enrolled in the trial will have their DST data recorded. Randomisation will occur at the point of DST completion, within severity groups as defined by DST results. Therefore both comparison and intervention groups will comprise a mix of symptom severities. Only participants randomly allocated to the intervention arm will receive the intervention as above. Participants identified as being likely to experience severe mental health symptoms in three months’ time and randomised to the intervention arm will receive assistance from a practice-based mental health care navigator to develop an individual care package. The care navigator is a registered health professional who will work with the patient, the GP and other providers to develop a care plan, support the patient through their care and ensure that elements of the care package are connected. Participants will be offered 8 appointments with the care navigator at their GP clinic over a 12 week period. Participants are free to take up the offer of care navigation or not. On completion of the DST, participants identified as being likely to have minimal/mild symptoms at 3 months and randomised to the intervention arm will receive a list of relevant low intensity services, matched to the areas prioritised by the participant. Services will include those delivered online, via telephone, via mobile app, and in the participant's local area, in order to assist participants find an option that is most acceptable and therefore most likely to be used. Participants are free to follow the recommendation or not, and are free to discuss it with their GP or not. It should be noted that the trial is designed to identify patients in the two groups above, however the DST will also identify a third group of patients – those whose mental health problems that are more severe than the minimal/mild group but less so than those in the severe/complex group. Patients in this ‘moderate’ group will not be randomised but instead will all enter into the usual care comparison arm (see below).

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Aged 18-75 2. Some level of mental health need, evidenced by: - a score of 2 or more on the PHQ-2, and/or - a score of 2 or more on the GAD-2, and/or - current use of medication for mental health 3. Able to complete the screening questionnaire and consent in English 4. Current Medicare card holder 5. Able to provide a mobile phone number and/or email address

Exclusion criteria

n/a

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026