A pilot study to evaluate feasibility and acceptability of training mental health workers in India to select case-specific intervention procedures within a dynamic modular treatment designed for a low-resource setting.

RATIONALE, AIMS AND OBJECTIVES: A key consideration in designing scalable solutions for improving global mental health involves balancing the need for interventions to be uncomplicated for mental health workers (MHWs) and the need for the intervention to be widely applicable to many clients. Often these needs are in competition, since interventions are routinely simplified by removing procedures or reducing their dynamic responsivity, which in turn lowers their overall utility in serving large, clinically diverse populations. The principal aim of this pilot study involved evaluating the feasibility and acceptability of a brief strategy designed to delegate problem classification and practice selection to MHWs operating within a flexible, modular, cognitive behavioural protocol. A secondary aim involved gathering data on which to base a hypothesis regarding the potential effectiveness of this strategy. METHOD: Within an open trial, an educationally diverse sample of local MHWs in India (N = 18) reviewed fictional case vignettes, classified mental health problems, and then selected practices before and after a two-hour training that included a one-page decision-making resource. Feasibility was measured by assessing the integrity of the study protocol and training, the measurement and administration of questionnaires as well as study recruitment and completion. Acceptability of the intervention was measured by MHW-perceived performance, ease of use, value, importance, and intention for continued use. Decision-making accuracy was assessed by comparing MHWs' clinical decisions with criteria established through consensus among psychologists with expertise in modular protocols. RESULTS: Results suggested high feasibility and acceptability on all metrics. Secondary analysis revealed that MHW's decision-making accuracy and confidence also significantly improved, providing a basis for the hypothesis that this brief approach is useful for building MHW capacity in low-resource settings. CONCLUSION: Overall these findings provide initial support for these methods and potential training outcomes to test within a larger, randomized controlled trial.

Design process and protocol description for a multi-problem mental health intervention within a stepped care approach for adolescents in India.

This paper documents the collaborative design of a mental health intervention for adolescents in India with anxiety, depression, or anger-related concerns. The process was characterized by three phases of formative activities: (1) an intensive review of the service context, (2) selection of an overall design strategy (e.g., whether to choose existing evidence-based treatments or build new treatments in context), and (3) a period of prototyping, testing, and refining. Each phase resulted in specific outputs, which were, respectively, (1) a detailed articulation of values and preferences (setting expectations for what the ideal protocol should be), (2) a set of build parameters representing a blueprint that managed strategic compromises for this context, and (3) a working protocol. We outline the steps of this design process, summarize data from an open-trial clinical case series, and illustrate the resulting working protocol, which will be tested in a future larger trial. We conclude with insights and observations likely to be relevant to protocol design activity in a variety of contexts, most particularly those in low-and-middle-income countries such as India.

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.

BACKGROUND AND OBJECTIVE: Common mental disorders (CMD) are a leading global burden of disease. Up to 30% of primary care attenders suffer from these disorders but most do not receive evidence-based drug or psychological treatments. There are no trials of interventions which attempt to integrate these treatments into routine primary care in developing countries. The aims of this trial (the MANAS Project) are to evaluate the clinical and cost-effectiveness of a collaborative stepped-care intervention for the treatment of CMD in India. STUDY DESIGN: A cluster randomized controlled trial will be implemented in the state of Goa, on the west coast of India. Twenty-four primary care facilities, 12 from the government sector and 12 from the private sector, will be enrolled in two consecutive phases. For each sector, facilities will be randomly allocated within strata defined by urban/rural location, population size and presence of a visiting psychiatrist. Facilities will be randomly allocated to receive the collaborative stepped care intervention or the enhanced usual care control intervention. Both arms share two components of the intervention, viz., routine screening, and in the government clinics provision of antidepressants. In addition, the collaborative stepped care arm also provides a range of psychosocial treatments delivered by a specially trained Health Counselor, and supervision by a visiting Psychiatrist. A total of 3600 primary care attenders who are detected to suffer from a CMD based on a validated screening questionnaire will be recruited. The primary outcome is the proportion of subjects who recover from an ICD10 defined CMD at baseline by 6 months. Additional endpoints at 2 and 12 months will assess the speed and sustainability of achieving the primary outcomes. Other outcomes will include recovery from ICD10 defined depression and incidence of ICD-10 among individuals who were sub-threshold cases at baseline. Economic and disability outcomes will be assessed to estimate incremental cost-effectiveness ratios. IMPLICATIONS: This will be the first trial of the effectiveness of a complex intervention aiming to integrate efficacious treatments for CMD into routine primary care in a developing country. If effective, its findings will have relevance to policy makers who wish to scale up treatments for CMD in primary care across the world, but mostly in those countries where specialist mental health services are few. STUDY REGISTRATION: The MANAS project is registered through the National Institutes of Health sponsored clinical trials registry and has been assigned the identifier: NCT00446407.