Background: The treatment gap for mental illness in Nigeria, as in other sub-Saharan countries, is estimated to be around 85%. There is need to prioritise mental health care in low and middle income countries by providing a strong body of evidence for effective services, particularly with a view to increasing international and government confidence in investment in scaling up appropriate services. This paper lays out the processes by which a programme to integrate evidence-based mental health care into primary care services in Nigeria was designed, including a research framework to provide evidence from a robust evaluation. Methods: This paper forms the first step in the overall process evaluation of the mhSUN intervention, where standard research practice indicates that the intervention, and its development, is clearly documented prior to subsequent evaluation. The report covers the period of programme development and evaluation design, and study site and design was chosen to allow generalisability and practical conclusions to be drawn for service development in Nigeria. In order to design an intervention that was informed by evidence and took into account local context and input of stakeholders, a structured process was followed, including: (1) Engagement of relevant stakeholders for information gathering and buy-in; (2) Literature review and gathering of pertinent evidence; (3) Situation analysis at a national and local level; (4) Model development (using Theory of Change); (5) Ongoing consultation, recognising the iterative nature of Theory of Change, and need for ongoing refinement of complex interventions. Results: The different sections of the structured approach resulted in outputs that built the necessary components (literature review, situation analysis) for informing the Theory of Change. A Theory of Change map is presented, which includes transparent documentation of the assumptions and logic behind the activities to drive the desired change. In addition, it documents the indicators necessary to measure fidelity and draw conclusions as to hypothesised effects of different mechanisms of action in subsequent evaluation. Conclusion: In addition to the details of ensuring robust evaluation design, there are a number of considerations that are particular to the context that must be taken into account in programme development, including the relationships between ultimate beneficiaries, implementers, host government and institutions, donors, and programme evaluators. Structured methods from existing frameworks can be drawn upon to use and collate relevant information to maximise the local applicability of a generic evidence base. Theory of Change, with its documented assumptions can form the basis of subsequent evaluation and iterative programme refinement, contributing to a more scientifically valid means of developing mental health programmes for scale up.
