Improving the outcomes of primary care attenders with common mental disorders in developing countries: a cluster randomized controlled trial of a collaborative stepped care intervention in Goa, India

Common Mental Disorders (CMD) are depressive and anxiety disorders which are typically encountered in community and primary care settings [1]. Although depressive and anxiety disorders are classified as separate diagnostic categories in ICD10[2], the concept of CMD is valid for public health interventions due to the high degree of co-morbidity between these disorders in primary care and the similarity in epidemiological profiles and treatment responsiveness [1, 3‐5]. In South-East Asia, 11% of Disability Adjusted Life Years and 27% of Years Lived with Disability are attributed to neuropsychiatric disease[6]. Depression is the most important neuropsychiatric cause of disease burden [7] and CMD lead to profound levels of disability through symptoms such as tiredness and sleep problems, and are associated with increased health care costs and reduced economic productivity [8‐11].

The majority of persons with CMD in developing countries seek health care in primary care [7]. A review of 8 epidemiological studies of CMD in South Asia [12] showed prevalence in primary care of 26.3% (95%CI 25.3%–27.4%). Recognition is poor in primary care, with fewer than 1/3^rd of clinically significant morbidity detected[13]. Primary care doctors tend to prescribe a greater number of symptomatic medications, such as injectable vitamins, for patients with CMD [14]. A WHO multinational study in general health care reported that nearly 10% of primary care attenders with CMD in the Indian study centre were prescribed psychotropic drugs[15]; however, the majority of prescriptions were for tranquilizers (benzodiazepines) rather than antidepressant drugs.

Three randomised controlled trials studying the efficacy of treatments for CMD in India, Uganda, and Chile were published recently [16‐19] All the studies targeted poor populations and tested treatment options that were intended to be feasible, affordable, and acceptable to the populations being studied. These trials attested to the efficacy of antidepressants and brief psychological treatments (interpersonal therapy), delivered in a stepped care model. All the trials showed significant improvements in disability levels in the intervention group; the Indian trial also showed that treating CMD produces significant reduction in total health care costs while the Chilean trial found that the additional cost for each depression-free day was roughly equivalent to the cost of a single bus fare [20].

Although evidence of the efficacy of antidepressants and brief psychological treatments has been available for decades[21], the scaling up of this evidence to routine primary care has been challenging [22‐24]. Efforts to improve the primary care treatment of CMD in developed countries include the development of treatment guidelines for CMD and dissemination of guidelines via the education of primary care providers[25, 26]. Physician education has been found to be associated with an increase in the recognition of CMD, but not with lasting improvements in patients' clinical outcomes [22, 25]. Successful quality improvement programs in developed countries have included, in addition to improving recognition rates, strategies which address other challenges such as the chronic and recurrent nature of CMD and the low adherence with evidence based treatments [27‐31]. A recent systematic review of the constituents of complex, collaborative care interventions which improve effectiveness for CMD [32] found that the use of routine screening of all attenders and the professional background of staff and specialist supervision predicted a favourable outcome.

However, this effectiveness evidence cannot be readily transferred to developing countries due to the widely different health systems. There are a number of obstacles to scaling up efficacious interventions to the 'real-world' primary care context in developing countries [33‐35]. The first is the low recognition rate of CMD by primary care doctors, for example because of somatic presentations [36]. The second is the inadequate use of evidence-based medications, including antidepressants (at inadequate dosage or for too short durations), and the frequent use of non evidence-based medications [37]. The third obstacle is that few patients receive non-drug treatments for CMD, typically because of the lack of human resources for psychosocial treatments. There is also a severe shortage of skilled mental health resources [38], and finally, low adherence with treatments. Although training programmes for health workers often show an increase in knowledge, the improvement in recognition rates are transient [36], and translation to improved clinical outcomes has not been evaluated [34, 39]. Evidence from mental health care demonstration projects show that expansion of care to within reach of the majority of the population in developing countries will necessitate appropriately trained non-specialized health workers working with specialized personnel [34]. The integration of mental health in primary care is acknowledged as the only feasible way of managing the burden of CMD in developing countries [7] yet there is no evidence that such care can be implemented effectively [34]. However, an intervention which seeks to achieve this goal will need to consider strengthening the human resources and support for primary care practitioners, which will inevitably entail increased financial investment. The potential that the intervention will be scaled up may thus hinge on its cost-effectiveness.

While the efficacy of specific intervention components (e.g., anti-depressant drugs) is established in developing countries, the same is not true for the effectiveness of intervention strategies that attempt to introduce these into usual primary care. The proposed trial is addressing whether a collaborative stepped-care intervention enables these treatments to be provided effectively in primary care and, if so, what are the marginal benefits and costs. There is genuine clinical equipoise concerning this research question in the context of developing countries where the intervention presents additional costs and where there are several other public health priorities. Under-powered trials are unethical for patients [66]; our sample size calculations are therefore based on conservative estimates and high power. No participant will be deprived of any treatment s/he would ordinarily receive. Participants in the enhanced usual care control facilities may benefit as a consequence of the screening and, in the PHCs, the provision of antidepressants to the pharmacy. Thus they will be provided with the results of the screening questionnaire and those who remain ill at 12 months will be offered psychiatric consultation by the Clinical Specialist. In addition, if any trial participant (in either arm) is found to have attempted suicide (assessed during outcome evaluation), the field work team will report this through an administrator to the intervention team who will make arrangements to provide psychiatric care for the participant. Explicit referral guidelines will be provided to doctors in the Enhanced usual care control arm for patients who may be suicidal or need specialist advice (to the local public psychiatric services available in three hospitals in Goa).

In cluster RCTs, consent for participation in a trial is needed both from the clusters and, depending on the type of intervention being delivered and outcomes assessed, from individual participants. In the MANAS trial, cluster level consent is being obtained as follows:

Individual participant consent is being obtained in two stages: after the screening, those who are screen-positives will be invited to participate in the CIS-R interview and thereby be enrolled in the trial; and for those selected for outcome evaluation, formal written consent will be obtained by the field researcher at the first visit to the participant in his/her home 2 months after enrollment.

Formal ethical approval has been obtained from the IRBs of the lead Goan organization (Sangath) and the London School of Hygiene & Tropical Medicine and has been approved by the Indian Council for Medical Research. The Trial Steering and Data Monitoring & Ethics Committees will monitor the progress of the trial. A fresh report will be made to both ethics committees of major changes in the protocol since the original proposal was assessed.

While there is evidence on what treatments work for CMD in developing countries, the question of how these can be effectively delivered in routine primary care remains unanswered [67]. This is one of the major research priorities in global mental health [68]. The results of the trial will be used to inform policy makers and practitioners in developing countries on the practical implementation, and the clinical and economic benefits of improving the management of CMD in primary care. The trial is likely to yield findings which are generalisable beyond the population of the study and, if effective, could be scaled up in health policy due to: the representative sampling of participants from rural and urban, private and public primary care facilities; the use of an intervention strategy which integrates evidence from efficacy trials from three developing countries and emphasizes acceptability (to practitioners, policy makers and participants), affordability (acceptable cost-effectiveness ratio) and availability (use of locally available resources); and the application of methods to address obstacles to the integration of mental health in primary care.

We acknowledge that the trial intervention will not tackle all the obstacles to the integration of mental health in primary care, such as the stigma associated with mental illness in the community [33, 35]. Some components of the intervention may not seem generalisable. First, is screening a feasible component of the intervention? Recognition of CMD is an essential requirement for providing an intervention. A strictly naturalistic trial may have chosen to recruit subjects referred by the primary care doctor. We ruled this out since there is good evidence to show that recognition rates are very low [10, 12, 14, 56] and that training doctors does not lead to sustainable higher rates of recognition[33]. Furthermore, a recent systematic review of collaborative care interventions found systematic identification of patients was one of only three specific ingredients which predicted a favorable response to the intervention [32]. Thus, screening in this trial is an integral component of the intervention as well as being used to identify a comparable sample of CMD patients in the Enhanced usual care control arm. With regards to scaling up, we believe that screening is feasible because of the high prevalence of CMDs in primary care attenders, the brevity of screening instruments (which may be reduced to just a couple of questions) [69] and the increasing literacy rates in many countries which makes self-completion feasible. The second component is that of the need for employment of a Health Assistant and a Health Counselor, additional human resources, in primary care facilities. However, the type of persons we will use in this role is relatively low-cost. Such persons who might suit these roles are easily available in most developing countries and could perform other roles, such as behaviour modification and lifestyle interventions for other chronic diseases. If Ministries of Health are to consider supporting mental health programmes which involve additional resources, data on the feasibility and cost-effectiveness of interventions are critical [34]; the proposed trial will provide the first systematic evidence of this kind from a low income country.