BackgroundThe Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable.MethodsWe propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions.ResultsOur application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework.ConclusionsIncorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology.Trial registrationClinical trials.gov: NCT02160249

Background-Amongst the challenges to improving care for depressive and anxiety disorders (the common mental disorders, CMD) in developing countries are the shortage of skilled human resources and the lack of availability of psychosocial interventions. The MANAS trial was implemented to test the effectiveness of a lay health worker led intervention in primary health care settings to improve outcomes of people with CMD in Goa, India.

Background Mental disorders are among the leading causes of non-fatal disease burden in India, but a systematic understanding of their prevalence, disease burden, and risk factors is not readily available for each state of India. In this report, we describe the prevalence and disease burden of each mental disorder for the states of India, from 1990 to 2017. Methods We used all accessible data from multiple sources to estimate the prevalence of mental disorders, years lived with disability (YLDs), and disability-adjusted life-years (DALYs) caused by these disorders for all the states of India from 1990 to 2017, as part of the Global Burden of Diseases, Injuries, and Risk Factors Study. We assessed the heterogeneity and time trends of mental disorders across the states of India. We grouped states on the basis of their Socio-demographic Index (SDI), which is a composite measure of per-capita income, mean education, and fertility rate in women younger than 25 years. We also assessed the association of major mental disorders with suicide deaths. We calculated 95% uncertainty intervals (UIs) for the point estimates. Findings In 2017, 197•3 million (95% UI 178•4-216•4) people had mental disorders in India, including 45•7 million (42•4-49•8) with depressive disorders and 44•9 million (41•2-48•9) with anxiety disorders. We found a significant, but modest, correlation between the prevalence of depressive disorders and suicide death rate at the state level for females (r²=0•33, p=0•0009) and males (r²=0•19, p=0•015). The contribution of mental disorders to the total DALYs in India increased from 2•5% (2•0-3•1) in 1990 to 4•7% (3•7-5•6) in 2017. In 2017, depressive disorders contributed the most to the total mental disorders DALYs (33•8%, 29•5-38•5), followed by anxiety disorders (19•0%, 15•9-22•4), idiopathic developmental intellectual disability (IDID; 10•8%, 6•3-15•9), schizophrenia (9•8%, 7•7-12•4), bipolar disorder (6•9%, 4•9-9•6), conduct disorder (5•9%, 4•0-8•1), autism spectrum disorders (3•2%, 2•7-3•8), eating disorders (2•2%, 1•7-2•8), and attention-deficit hyperactivity disorder (ADHD; 0•3%, 0•2-0•5); other mental disorders comprised 8•0% (6•1-10•1) of DALYs. Almost all (>99•9%) of these DALYs were made up of YLDs. The DALY rate point estimates of mental disorders with onset predominantly in childhood and adolescence (IDID, conduct disorder, autism spectrum disorders, and ADHD) were higher in low SDI states than in middle SDI and high SDI states in 2017, whereas the trend was reversed for mental disorders that manifest predominantly during adulthood. Although the prevalence of mental disorders with onset in childhood and adolescence decreased in India from 1990 to 2017, with a stronger decrease in high SDI and middle SDI states than in low SDI states, the prevalence of mental disorders that manifest predominantly during adulthood increased during this period. Interpretation One in seven Indians were affected by mental disorders of varying severity in 2017. The proportional contribution of mental disorders to the t...

Even though psychological treatments have been advocated as treatments for a range of mental disorders by the WHO for scaling up through primary care globally, the vast majority of potential beneficiaries are unable to access these treatments. Two major barriers impede the path between evidence based treatments and improved access: the lack of skilled human resources and the acceptability of treatments across cultures. This essay synthesizes the experiences of programs which developed and evaluated psychological treatments for depression in three resource poor developing countries. These programs addressed the human resource barrier by training lay or community health workers to deliver the treatments and addressed the acceptability barrier by systematically adapting the treatment to contextual factors. All programs demonstrated significant benefits in recovery rates when compared with usual care demonstrating the effectiveness of the approach. The implications for these experiences to improving access to psychological treatments in the global context are discussed.