Moving beyond RCT evidence in mental health?

Problems of mental health and their treatments are infinitely complex. In many cases, traditional randomised controlled efficacy trials fail to capture this complexity, or to provide meaningful answers. This month in Australian & New Zealand Journal of Psychiatry (ANZJP) several papers illustrate the advantages of pragmatic effectiveness trials and of more innovative methodology in mental health.

Treatment of first episode psychosis is particularly controversial and has been the subject of much debate in this journal. As Galletly et al. (this issue) note, one issue with widely varying opinions is that of the need for longer term antipsychotics. Important randomised controlled trials (RCTs) are underway in this area but Galletly et al. also call for services to engage in what would essentially be an open-label follow-up of first episode psychosis. They suggest that collection of long-term naturalistic data over a number of sites, using agreed protocols, would add to data regarding, for example, the characteristics of patients who do well when medication is discontinued compared with those who do not. This is an excellent example of a situation which may be better answered by this type of methodology, rather than a closely controlled RCT. The challenge, of course, is to persuade a medically dominated grant awarding body to support such a methodology.

Galletly et al. begin their editorial with a question asked by many sufferers of first episode psychosis – ‘when can I stop my medication?’ It is important for clinicians to have evidence to guide advice given in response to such a question but the process of making such decisions is also important. Kokanovic et al. (this issue) explore the experience of mental health service users, family supporters and clinicians in shared decision making, in a qualitative study. Barriers to good supported decision-making practices were identified including negative interpersonal experiences, disempowerment of clinicians in service systems, prevailing attitudes towards mental health service users and the associated stigma and discrimination.

Problematic attitudes to mental health are often particularly evident in the Press. In Tamil Nadu, India, there are an estimated 250,000 suicide deaths annually. Unfortunately, the results of the analysis of Armstrong et al. (this issue) suggest that reporting in daily newspapers is unhelpful. Most reports in this content analysis were short and explicit while only 2.5% had contact details for a suicide support service. The paper makes a positive suggestion of attempting to understand the perspectives of news reporters, in order to work with them to improve suicide reporting.

Another ongoing subject of debate in the journal is the contribution of adverse childhood experiences to mental ill health. Jorm and Mulder (2018) have recently argued that in fact reducing or mitigating these experiences may have considerably more impact on improving mental health than improvements in treatment which are in effect the ‘ambulances at the bottom of the cliff’. This month Hiscock, a paediatrician, gives a perspective on this debate, arguing that significant gains can be made first by better training the workforce involved in detecting adverse childhood experiences, second by supporting them to know how to respond, particularly in knowing what local services are available or better to have fully integrated services. Third, Hiscock argues that trials in the United States do provide evidence for clinicians regarding how to help children in adversity and how to foster resilience.

In a series of papers in ANZJP, predictors of the course of bipolar disorder have been examined. In the study of Gold et al. (this issue), data come from the systematic treatment enhancement program for bipolar disorder (STEP-BD), one of the largest pragmatic, effectiveness trials in psychiatry to date (Sachs et al., 2003). Patients had the choice of entering a RCT of intensive psychotherapy compared with a three-session psychoeducation-based treatment for bipolar depression. For this analysis, data from all three intensive psychotherapies were examined together and patients were deemed to be ‘recovered’ if they met criteria for 8 weeks – an outcome which was considered in the design of the study to represent ‘meaningful recovery’ and is once again based on the principle of effectiveness (Sachs et al., 2003). Approximately 60% of patients with bipolar disorder develop a substance use disorder at some point in their lifetime. However, most RCTs exclude patients with a current substance use disorder, therefore adding nothing to the literature on outcome for this group of patients. The results of this study are both interesting and perhaps surprising, showing that 74.5% of patients with a current substance use disorder, compared to 56.5% without a current substance use disorder, recovered from bipolar depression. The origin of this difference is not clear but it at least suggests that intensive psychosocial treatment of bipolar depression is important, even before the substance use disorder is addressed. Recently, Caldieraro et al. (2017), once again in a pragmatic clinical trial, showed that the cluster of ‘deactivation’ symptoms in bipolar depression was associated with poorer remission rates in bipolar depression. In this month’s issue, Rote et al. examined the effect of impulsivity on outcome in bipolar disorder. Trait impulsivity and particularly attentional impulsivity, in euthymic bipolar patients, was a strong predictor of illness severity (measured using a morbidity index) over an average of 1 year of follow-up.

Thus, pragmatic effectiveness trials and other research designs are beginning to, and have further potential to, provide data on the complexities of mental health issues, their course and treatment, and perhaps even inform prevention strategies.