Over 90% of mental health problems are treated in primary care, and those working in secondary care often wrongly assume that the adjective ‘common’, when applied to mental health problems, means ‘simple to treat’. Distinguishing between ‘distress’ and ‘disorder’ isn’t straightforward (Gask, 2020) and can be very difficult in the high volume setting of primary care with fast throughout and short appointments. Both over- and under-treatment are common.

Stepped-care approaches are effective for depression and anxiety (van Straten et al., 2015; Ho et al., 2016) and aim to minimise this treatment mismatch. However, it isn’t clear how to allocate people to an appropriate initial step. Should we all begin at the first step (usually low-intensity treatment) and step up if symptoms do not improve (true stepped care) or match level to initial severity on the basis of assessment of needs, so stratified care?

In Australia, psychological therapy is funded for people with moderate symptoms. Nevertheless, it can be challenging to distinguish people who would best benefit from a particular intensity of care and there is a treatment gap for those with both mild and more severe symptoms.

Link-me, a digital, prognostic patient-completed Decision Support Tool, (DST) predicts severity of depression or anxiety, identifies priorities and recommends the appropriate step or level of interventions for the patient to the primary care professional.

This study (Fletcher et al, 2021) tested the hypothesis that using the DST to stratify patients into prognostic groups (mild/moderate/severe) and provide matched treatment recommendations (low or high intensity) would result in a greater reduction of psychological distress at 6 months than usual care plus attention control (UC+).

Methods

This was a large pragmatic stratified two-arm randomised controlled trial (see the protocol of the study in Fletcher et al., 2019).

Inclusion of participants

Adults aged 18–75 years reporting depressive or anxiety symptoms (a score of 2 or more on the 2 items version of the Patient Health Questionnaire (Kroenke et al., 2003) or the 2 items General Anxiety Disorder Scale (Kroenke et al., 2007) or current use of mental health medication were recruited in the waiting room from 23 general practices in Australia.

Participants completed the Decision Support Tool on a tablet and were classified into 3 prognostic groups (minimal/mild, moderate, severe). Those in the minimal/mild and severe groups were eligible for inclusion. Those in the moderate group were excluded.

Randomisation process and blinding

Participants were individually and randomly assigned (1:1) by a computer-generated allocation sequence to receive either prognosis-matched care (intervention group) or usual care plus attention control (UC+) (control group). They were not blinded, but intervention providers were only notified of those allocated to the intervention group. However, the outcome assessment was blinded.

Procedures

Intervention group: participants received automated feedback on responses and were guided via the online tool to set individual mental health priorities and rate their motivation to address them.

On the basis of the prognostic group they were allocated to:

• Mild/minimal group: received low-intensity options through online, telephone, mobile app or in-person in the community.
• Severe: received high intensity ‘care navigation’, informed by collaborative care and motivational interviewing, delivered in general practice, with up to 8 structured contacts with a care navigator (working with the GP) to develop and implement a care plan, and link to local health and social care resources.

Control group: participants were not provided with any feedback and encouraged to discuss any mental health concerns with their GP.

Outcomes

Primary outcome: difference in the change in scores between the intervention and control group, and within prognostic groups, on the 10-item Kessler Psychological Distress Scale at 6 months.

Secondary outcomes: change in K10, PHQ-9, GAD-7 and EuroQol 5-dimension quality of life questionnaire [EQ-5D-5L] at 6 and 12 months. Days out of role (number of days totally and partially unable to study in the past 4 weeks due to symptoms in K10).

The authors state that economic data will be reported separately.

Results

24,616 patients were invited to complete the eligibility screening survey. Of those, 1,671 were included and randomly assigned by the DST to either the intervention group (n=834; 416 in the minimal mild group vs. 421 in the severe group) or the control group (n=837).

Prognosis-matched care was associated with greater reductions in psychological distress than usual care plus attention control at 6 months (p=0·03), with a standardised mean difference (SMD) of –0·09 (95% CI –0·17 to –0·01). This reduction was also seen in the severe prognostic group (p=0·003), with a SMD of –0·26 (–0·43 to –0·09, including the pre-specified clinically significant relevant difference of -0.30), but not in the minimal/mild group (p=0·73), with a SMD of 0·04 (–0·17 to 0·24).

Differences were larger among those who received some or all aspects of the intervention (SMD range –0·58 to –1·15).

At 12 months there was no evidence of a treatment effect on K10 overall. Significant effects on any other secondary outcomes were not robust to sensitivity analyses.

Conclusions

The authors concluded:

Prognosis based matching of interventions reduces psychological distress in patients with anxiety or depressive symptoms, particularly in those with severe symptoms, and is associated with better outcomes when patients access the recommended treatment.

They suggest better integration of the Link-me approach with existing health care systems and consider that implementation into routine practice could help reduce the burden of disease associated with common mental health conditions.

Strengths and limitations

The study has various strength:

• A large and representative sample of patients drawn from the primary care population
• DST tool addresses most mental health problems managed in primary care
• Any patients with anxiety or depression were eligible regardless of whether primary or secondary concerns
• Sufficient power to examine efficacy across anxiety and depression symptoms.

However, some limitations can be identified:

• Exclusion of the ‘moderate’ group because psychological services already available, which might (I suspect) on occasions be of greater intensity than those offered to ‘severe’ group in this study
• Fewer people than anticipated had minimal/mild symptoms and more with severe symptoms
• No comparison group providing access for GPs/patients to novel interventions without DST component
• Potential for generalisability as DST was offered to all attendees in the waiting room.

Implications for practice

• But what does this offer beyond the routine practice?
• Can this tool be more widely implemented?

As with many primary care projects, this study recruits all-comers in the waiting room; with a screening tool. Screening alone isn’t sufficient to improve outcomes except when appropriate care is provided (Gilbody et al., 2001). This study aims to provide this; succeeding with those experiencing more severe symptoms through linking them up to a form of collaborative care, which we already know is effective (Artcher et al., 2012). Would the same be achieved if primary care professionals themselves were asked to give the patient the DST to complete on a tablet? Who, in the team, would make time to do that? What if they disagree with the recommendations for treatment? Furthermore, as a patient, I would definitely want a share in the decision-making too. Finally, what if the interventions alone were just made easier for professionals and patients to access?

In England, we are in the process of a massive change in services for people who access mental health care at the interface between primary and specialist care (NHS, 2019). Such a decision support tool may be helpful, and potentially save time at what is often the rate-limiting point in stratified stepped care – the initial assessment – but only as an adjunct to the human interaction, which was undoubtedly performed by those researchers in the waiting room. Working hard – as ever – to engage the participants.

Statement of interests

Linda Gask has previously been involved in randomised trials of collaborative care both for common mental health problems and severe and enduring mental illness.

Links

Primary paper

Fletcher S, Spittal MJ, Chondros P. et al (2021) Clinical efficacy of a Decision Support Tool (Link-me) to guide intensity of mental health care in primary practice: a pragmatic stratified randomised controlled trial. The Lancet Psychiatry. 8(3) 202-214.

Other references

Archer J, Bower P, Gilbody S, et al (2012) Collaborative care for depression and anxiety problems. Cochrane Database of Systematic Reviews. (10).

Fletcher S, Chondros P, Palmer VJ,  (2019) Link-me: Protocol for a randomised controlled trial of a systematic approach to stepped mental health care in primary care. Contemporary clinical trials. 78:63-75.

Gask L (2020) ‘I mean what is depression?’ How GPs distinguish between distress and depression. The Mental Elf April 20^th

Gilbody SM, House AO, Sheldon TA. (2001) Routinely administered questionnaires for depression and anxiety: systematic review. British Medical Journal 322(7283):406-9.

Ho FY, Yeung WF, Ng TH, et al. (2016) The efficacy and cost-effectiveness of stepped care prevention and treatment for depressive and/or anxiety disorders: a systematic review and meta-analysis. Sci Rep  6: 29281.

Kessler RC, Andrews G, Colpe LJ, et al. (2002) Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychological medicine. 32(6):959-976

Kroenke K, Spitzer RL, Williams JB. (2003) The Patient Health Questionnaire-2: validity of a two-item depression screener. Medical care. 14:1284-1292

Kroenke K, Spitzer RL, Williams JB, et al (2007) Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Annals of Internal Medicine. 146(5):317-325.

National Health Service and National Collaborating Centre for Mental Health (2019) Community Mental Health Framework for Adults and Older Adults. NHSE.

van Straten A, Hill J, Richards DA, et al. (2015) Stepped care treatment delivery for depression: a systematic review and meta-analysis. Psychological  Medicine  45: 231–246.

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