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Developing mental health interventions 

Developing mental health interventions
Chapter:
Developing mental health interventions
Author(s):

Abhijit Nadkarni

, Mary J. De Silva

, and Vikram Patel

DOI:
10.1093/med/9780199680467.003.0003
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Introduction

In this chapter, we discuss why mental health interventions can be considered as ‘complex interventions’ and the need for a systematic framework for the development and evaluation of complex interventions. We describe the MRC framework, the most widely used framework for this purpose, and illustrate the steps that are followed to develop mental health interventions using the case study of PREMIUM, a research programme in India which is developing and evaluating psychological treatments for depression and alcohol use disorders (AUD). We also discuss two complementary frameworks (the Normalization Process Theory (NPT) and the Theory of Change (ToC)) which can strengthen the methodology for the development of complex interventions, enhancing the likelihood of their effectiveness and ultimate implementation.

What are complex interventions?

Complex interventions in health care are made up of a number of interconnected components, acting both independently and interdependently (1). Characteristics of interventions that make them complex include: multiple interactions between the components of the intervention; number and difficulty of behaviours required by those delivering or receiving the intervention; number of groups or organizational levels targeted by the intervention; number and variability of outcomes; and the degree of flexibility or tailoring of the intervention (1).

The Grand Challenges in Global Mental Health initiative aimed to identify research priorities that will make a substantial and immediate impact on the lives of people living with mental health problems (2). Virtually all of the leading priorities were for expanding access to evidence-based treatments for mental health problems, for example through integrating packages of care into routine primary health care, developing effective treatments for use by non-specialists, and providing effective and affordable community-based care and rehabilitation. Such interventions usually comprise biological, psychological, and social components delivered in various combinations. Each component might work independently by itself and also in combination with the other components to achieve a desired outcome. Besides fulfilling this fundamental characteristic of complex interventions, most mental health interventions also fulfil the criteria for complexity through a host of other factors which characterize complex interventions. Table 3.1 gives examples of some interventions that have been evaluated through RCTs, with reasons for why they are complex interventions.

Table 3.1 Examples of interventions to address mental health problems

Intervention

Reason for complexity

Yuva Mitr: a multimodal community intervention programme for promoting health and wellbeing of youth in India (3)

  • Multiple components, e.g. peer education programme, teacher training, and health information material

  • Multiple groups or organizational levels targeted by the intervention, e.g. teachers, peers

  • Multiple outcomes, e.g. mental health, violence

COPSI: a community-based intervention for people with chronic schizophrenia (4)

  • Multiple components, e.g. psychiatric care and rehabilitation

  • Multiple providers, e.g. psychiatrists, community-based workers and supervisors

  • Multiple outcomes, e.g. adherence with drug treatment, symptoms, disability

MANAS: a lay counsellor-led intervention in primary care for people with depression and anxiety disorders (5)

  • Multiple components, e.g. psychoeducation, interpersonal therapy, antidepressant therapy

  • Variety of behaviours required by counsellors, e.g. liaison with primary care team, referral to specialist, engagement with supervision

  • Number of providers, e.g. primary care doctor, counsellor, supervisor

To illustrate the point, let us look at the MANAS project, a collaborative stepped-care intervention led by lay counsellors for common mental disorders (depressive and anxiety disorders) in primary care in Goa, India (5). The effective implementation of the intervention required a collaborative approach between three key team members: the lay counsellor, the primary care physician, and a visiting psychiatrist. The locally recruited counsellors did not have health backgrounds. After a structured 2-month training course they acted as case-managers for patients with common mental disorders (CMD) and took overall responsibility for delivering all the non-drug treatments in close collaboration with the primary care physician and the psychiatrist. The intervention comprised multiple components, e.g. psychoeducation, antidepressant drug treatment, and interpersonal psychotherapy, delivered in a stepped manner (i.e. tailored to the needs of the individual patient). For example, psychoeducation was provided to all patients, while antidepressant drugs were recommended only for moderate or severe CMD. Referral to the clinical specialist was reserved for patients who were assessed as having a high suicide risk at any stage, were unresponsive to the earlier treatments, posed diagnostic dilemmas, had substantial co-morbidity, or for whom the primary care physician requested a consultation. Every facility team was supported by a psychiatrist who visited about once a month and was also available for consultation on the telephone to discuss cases.

As we can see here, the complexity of this intervention arises from a host of factors, which include: the interactions between specific components (psychoeducation, interpersonal therapy, antidepressants); the number of behaviours required by those delivering the intervention (e.g. referral to specialist, engaging with supervision) or receiving the intervention (e.g. regular attendance to treatment sessions, compliance with medications, adherence with strategies like breathing exercises); the number of providers (lay counsellors, primary care doctors, psychiatrists); and the degree of flexibility or tailoring of the intervention permitted (flexible number of sessions, intensity of intervention based on severity of symptoms, referral to specialist as per need). Similarly, as with most mental health interventions, there are multiple components dynamically interacting with each other with varying levels of complexity within the various component parts that make up the interventions.

The need for structured frameworks to design mental health interventions

The inherent complexity of mental health interventions makes their development and evaluation a complex process too. To an evaluator, complex interventions pose a number of methodological challenges which generally accompany any successful evaluation. In particular, complex interventions bring with them special challenges related to the ‘difficulty of standardizing the design and delivery of the interventions, organizational and logistical difficulty of applying experimental methods to service or policy change, and the length and complexity of the causal chains linking intervention with outcome’ (<http://www.mrc.ac.uk/complexinterventionsguidance>). Hence, a structured approach to the development and evaluation of complex interventions helps researchers to keep track of the research process and also ensures that the process is systematic, rigorous, and replicable. One could argue that while the development, piloting, evaluation, reporting, and implementation of a complex intervention is a lengthy process, the most important stage is the evaluation of the intervention. However, by forgoing adequate formative work necessary for the development of a complex intervention one might be dooming it for failure. As one example, consider an intervention that has been beautifully designed on paper but has very poor adherence in practice. To ensure that scarce resources are not wasted on evaluating interventions that might not work for lack of formative developmental work, one should first develop the intervention to the point where it can reasonably be expected to have a worthwhile effect, before devoting extensive time and resources on a substantial evaluation. Consequently, devotion of adequate time and resources with rigorous application of a structured framework, not just to the main evaluation but also to the development of the intervention, will result in a better designed intervention, that is easier to evaluate, more likely to be effective, and thus more likely to be worth implementing. Table 3.2 highlights some of the issues that may be covered in the formative and pilot work and possible methods of doing that.

Table 3.2 Aims and methods of doing formative research

Aim of formative research

Method

Understanding the available evidence and identifying gaps that need to be addressed during intervention development

Identifying an appropriate and recent systematic review

Conducting a new systematic review

Proposing a theory on how the intervention will potentially work

Identifying existing evidence through review of the literature

Qualitative research involving experts in the field, intended recipients of the treatment, and potential delivery agents

Treatment development workshops

Assessing acceptability and feasibility of the intervention

Qualitative research involving experts in the field, intended recipients of the treatment, and potential delivery agents

n of 1 studies

Case series

Fine-tuning the procedures for the evaluation

Case series

Pilot RCT comparing the intervention against the control

Systematically conducted formative research prior to the definitive evaluation will also ensure that due consideration is given to the context in terms of the socioeconomic and cultural background, the health system, the nature of the problem that is being targeted, and the mechanisms by which the intervention works. Three primary questions are addressed in the development of an intervention, namely the feasibility (how logistically possible it is to deliver), acceptability (whether service users and providers find the intervention acceptable to receive and deliver), and scalability of the intervention (the extent to which the intervention could be delivered to a much larger population). A highly effective intervention is practically useless in the real world if it is not possible to deliver it, does not engage the target group (both the recipients and the delivery agents), and cannot improve access as it cannot be widely implemented.

Frameworks for the design and evaluation of complex interventions

The complex nature of mental health interventions leads to a host of challenges for researchers, in addition to the other routine difficulties that any successful evaluation of an intervention must overcome. These additional challenges include those related to the contextual fit of the intervention, as well as the length and complexity of the causal chains that link the intervention to the outcomes.

In 2000, the MRC published a Framework for the Development and Evaluation of RCTs for Complex Interventions to Improve Health, to help researchers to recognize and adopt appropriate methods to tackle such challenges (<http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC003372>). This framework had five phases which progressed sequentially: (1) ‘preclinical’ or theoretical (establish the theoretical basis that suggests that the intervention should have the effect(s) it is expected to); (2) phase I or modelling (delineating an intervention’s components and how they interrelate and how active components of a complex package may relate to either surrogate or final outcomes); (3) phase II or exploratory trial (experiment with the intervention, varying different components to see what effect each has on the intervention as a whole); (4) phase III or main trial (evaluation of a complex intervention in the main RCT); and (5) phase IV or long-term surveillance (a separate study to establish the long-term and real-life effectiveness of the intervention) (6) (see Fig. 2.1 in Chapter 2).

Over the years, as this framework was increasingly implemented, its limitations became apparent. Some of these limitations included the linearity of the various phases of the model precluding iterative work, the apparent lack of evidence for many of the recommendations, the limited guidance on how to address the intervention’s development and implementation phases, and the lack of attention to the social, political, or geographical context in which interventions were delivered (<http://www.mrc.ac.uk/complexinterventionsguidance>). As a consequence, an updated and extended revised version was developed and published in 2008 (7). Not only did this new framework emphasize the strengths of the original framework but it also addressed its limitations. What emerged was a considerably strengthened framework which was a more flexible and less linear model of the process, gave due weight to the development and implementation phases, and provided examples of successful approaches to the development and evaluation of a variety of complex interventions.

The main stages and the key functions and activities at each stage of the MRC framework are as follows (Fig. 3.1) (7): Development; Feasibility/piloting; Evaluation; and Implementation. Each of these phases are described in more detail next, with the case study of an ongoing programme in India (PREMIUM) to illustrate the application of the first two phases. Further examples of these phases can be found in the case studies in the second part of this book. Detailed descriptions of the third phase are found in the descriptions of the trials also in the second part of the book, while examples of the final phase can be found in Chapter 16 (De Silva et al.). At the level of a large-scale implementation of an effective intervention another framework that speaks well with the MRC framework is the NPT (8), which identifies factors that affect the assimilation of complex interventions into routine practice. This in turn can inform the type of formative work that needs to be done in the pre-evaluation phases of the MRC framework (Box 3.1).

The development and feasibility/piloting phases of the MRC framework

In this section we describe the ‘treatment development’ and ‘feasibility/piloting’ phases of the revised MRC framework using the example of PREMIUM, a research project in India. PREMIUM aims to elaborate a psychological treatment development and evaluation methodology that will lead to new, culturally appropriate, feasible, acceptable, affordable, and effective psychological treatments for the target disorders of harmful drinking (HD) (in men) and Depressive Disorder in primary care. The methodology adopted in PREMIUM seeks to specifically address barriers to making psychological treatments accessible by ensuring that the treatments can be delivered by non-specialist health workers and that the treatment is culturally appropriate. The case study in this chapter focuses on the development of the treatment for HD in men.

Developing a complex intervention

This involves identifying the evidence base, identifying or developing appropriate theory (the likely process of change) by drawing on existing evidence and theory, supplemented if necessary by new primary research, and modelling process and outcomes to provide important information about the design of both the intervention and the evaluation.

Identifying the evidence base

The starting point for developing an intervention is to be fully aware of the relevant, existing evidence base. A systematic review of treatments for the target condition is a good place to begin. Sometimes one might find a recent high-quality review, but often you may need to conduct a systematic review that is specifically designed to answer questions relevant to the intervention being developed. Such a systematic review will help identify previous studies that provide empirical evidence for the same or a similar intervention as the one that is being developed and/or treatments for the same or similar disorder for which the intervention is being developed.

Identifying/developing appropriate theory

A theory is a set of assumptions, propositions, or accepted facts that attempts to provide a plausible explanation for a causal relationship between observed phenomenon, in this case, the intervention and outcomes. This implies that attention to the theory that drives an intervention is more likely to lead to an effective intervention rather than relying on a purely empirical or pragmatic approach. However, this is easier said than done in the case of complex interventions as the rationale behind how change will be achieved may not be clear at the outset. Hence, a vital task in the development stage is to develop a theoretical understanding of how the intervention will lead to the desired outcomes. This could be done by examining existing evidence and theory, and supplemented if necessary by new primary research. A ToC (see Fig. 3.2) may be very helpful at this stage in constructing a causal pathways map of how the intervention and its different components are expected to lead to the desired outcomes. Note that theory can be revised based on experiences gathered during the piloting phase and based on the results of the evaluation phase (consistent with the iterative nature of the revised MRC framework).

Fig. 3.2 SHARE ToC: peer counselling for maternal depression in Goa, India.
Fig. 3.2 SHARE ToC: peer counselling for maternal depression in Goa, India.

Fig. 3.2
SHARE ToC: peer counselling for maternal depression in Goa, India.

(1)Kakuma R, Minas H, van Ginneken N, Dal Poz MR, Desiraju K, Morris JE, et al. (2011) Human resources for mental health care: current situation and strategies for action. Lancet, 378(9803):1654–63.

(2)Rahman A, Malik A, Sikander S, Roberts C, Creed F (2008) Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet, 372(9642):902–9.

(3)Yang L, Lo G, et al. (2012) Effects of labeling and interpersonal contact upon attitudes towards schizophrenia: implications for reducing mental illness stigma in urban China. Soc Psychiatry Psychiatr Epidemiol, 47(9):1459–73.

Modelling process and outcomes

Modelling a complex intervention prior to full evaluation helps to gain understanding of how the intervention works (for example through the independent and interactive effects of each component) and its possible effects (for example intermediate and final outcomes). Thus, modelling a complex intervention prior to a full-scale evaluation can provide important information about the various components of the intervention and their interrelationships and also helps to identify possible weaknesses in the intervention pathway which can then inform refinements in the intervention. Besides demonstrating how the intervention works, modelling helps to identify potential barriers to successful implementation of the intervention in the evaluation phase.

An example of modelling processes can be illustrated by the following example of the development of a guided self-help intervention for depression (9). Two systematic reviews were conducted and the results were synthesized with a consensus process which sought to interpret the evidence and address the ambiguities that remained. The results of the two reviews and consensus process were combined in a matrix, with each column of the matrix detailing one of the ‘core components’ of the intervention that the researchers wished to address, and the rows referring to the results from each of the three data sets (the two reviews and consensus process). This matrix was used as the platform for a discussion within the trial team to derive the final intervention to test. The ToC (described in the section ‘The ToC approach for intervention development and evaluation’) is also a useful framework to test the proposed causal pathways through modelling (see Box 3.2).

Feasibility and piloting

Evaluations of interventions are often compromised because of barriers related to the acceptability of the intervention, adherence with the intervention, delivery of the intervention, recruitment of and retention of participants, and inadequate effect sizes. The aims of this phase of the framework include testing procedures and the intervention for their acceptability, estimating the likely rates of recruitment and retention of subjects, and the calculation of appropriate sample sizes. To achieve these aims a mixture of qualitative (e.g. to understand acceptability of the intervention) and quantitative (e.g. to estimate retention rates) methods is needed. Depending on the results, a series of studies may be required to progressively refine the intervention as well as the design of the definitive evaluation. In the final step before the definitive trial, a pilot study is carried out. Typically, a pilot study could be designed as a smaller controlled study (with or without the element of randomization) or as a cohort study of individuals who are offered the intervention (i.e. without a control group). Thus, a pilot study is usually a smaller version of the planned definitive evaluation and should usually involve a mixture of qualitative and quantitative methods (See box 3.3).

Evaluating a complex intervention

Complex interventions can be evaluated using a range of randomized controlled study designs and an appropriate one needs to be selected based on the research questions and the context. Along with evaluating the efficacy/effectiveness of the intervention, it is useful to conduct a process evaluation and an economic analysis. The process evaluation provides an understanding of why an intervention succeeds (or fails) and an economic evaluation helps make the results more meaningful for decision-makers. Details of these methods and case studies can be found in other chapters of this book. In some circumstances, when an experimental approach is not feasible, for example because the intervention applies to the whole population, or because large-scale implementation is already under way, alternative non-experimental designs may be considered (see Chapter 16).

Implementation and beyond

The research process does not end after an intervention is proven to be effective. It is important that the intervention is successfully implemented so that its advantages are accrued by larger sections of the population for whom it was originally developed. Addressing the questions (Box 3.1 on NPT) during the early phases of intervention development promises an intervention that is more likely to be scaled up. Examples of some strategies for a potentially successful implementation plan include: involving stakeholders in the choice of question and design of the research; provision of evidence in an integrated and graded way; taking account of context; identifying and generating evidence for key elements relevant to decision-making, such as benefits, harms, and costs; making recommendations as specific as possible; and using a multifaceted approach involving a mixture of interactive dissemination meetings, audit, feedback, reminders, and local consensus processes. Successful implementation needs to be supplemented by measures to monitor rare or long-term impacts through routine data sources and record linkage, or by recontacting study participants. The ToC (described in the section ‘The ToC approach for intervention development and evaluation’) may be a useful framework to hang the above methods onto, to assist in planning and evaluating the scale-up of an intervention. Implementation of complex interventions is described in greater detail in Chapter 16.

The ToC approach for intervention development and evaluation

While the MRC framework provides extremely useful guidance on how to develop and evaluate complex interventions, implementing complex interventions within a health service setting, such as is the case for most global mental health trials, provides additional challenges that the MRC framework has been criticized for not adequately addressing. In addition, conducting trials in low-resource settings poses additional challenges which the MRC framework was not originally designed to address (see Table 3.3).

Table 3.3 Challenges to using the MRC framework in health service trials, particularly in low-resource settings

MRC framework

Health service trials, particularly in low-resource settings

Medical focus

Drug plus psychological and social interventions

Patient focused

Health care provider/health system focus

HIC focused

LAMIC focused with added complexity such as medicine stock-outs, staff shortages, and lack of training and awareness. This means that the interventions delivered in LAMIC are often more complex than those in HIC, as they involve health system strengthening before the intervention can begin to be delivered

Control over setting

Little control over setting, e.g. changes to policy context and contextual factors which may interact with interventions

High research capacity

Low research capacity: evaluation may interact with intervention

Implementation

Sustainability and scalability of intervention need to be considered in the light of unstable funding and limited resources

In addition, the MRC framework has been criticized for its ‘lack of specific theory-driven approaches to design and evaluation’ (10). Prospective, theoretically driven process of intervention design and evaluation is required in order to understand not just whether, but how and why an intervention has a particular effect, and which parts of a complex intervention have the greatest impact on outcomes. Integrating ToC into the MRC framework may provide a solution.

What is ToC?

ToC is ‘a theory of how and why an initiative works’ which can be empirically tested. It is developed in collaboration with stakeholders and modified throughout the intervention development and evaluation process through an ‘ongoing process of reflection to explore change and how it happens’ (11, 12). It is visually represented in a causal pathways map which illustrates how an intervention is expected to achieve its impact within the constraints of the setting in which it is implemented (see Fig. 3.2 for an example of a ToC map of a peer-led counselling intervention for maternal depression developed in Goa, India).

Unlike logic models or driver diagrams which are either linear or cyclical in nature and aim to present a simplified model of action, ToC seeks to reflect the complexity of the causal pathways through which the intervention leads to real-world impact. ToC is not a sociological or psychological theory of why change occurs, such as Complexity Theory (13) and the Theory of Planned Behaviour (14), but a framework that describes how the intervention affects change. These sociological or psychological theories could be inserted at key points in the ToC to explain why particular links happen. A ToC approach is complementary to other frameworks that seek to reduce the chance of implementation failure, such as NPT (8) (Box 3.1). While NPT provides a framework detailing what questions should be asked to design an intervention that is more likely to be ‘normalized’ into routine practice, ToC provides an explanation for how those questions can be answered.

Developing a ToC

At the start of the intervention development phase, ToC uses a participatory approach by bringing together a range of stakeholders (for example health service planners, health care workers, and service users) to develop a ToC map and to encourage stakeholder buy-in to the project (15). This could take the form of a series of workshops, interviews, or focus groups, with the choice of method based upon what is locally feasible and acceptable (16).

Stakeholders first agree on the real-world impact they want to achieve. They then identify the causal pathways through which this change can be achieved in that context using the available resources. These are articulated as a series of outcomes, the order of which can be adjusted as the pathway develops. Determining what contextual conditions are necessary to achieve the outcomes, what resources are required to implement the interventions, and how the programme gains the commitment of those resources are crucial outputs of the process.

Key components of the ToC map include:

  1. 1 identifying the interventions needed to move from one outcome in the causal pathway to the next;

  2. 2 articulating the evidence for each link in the pathway (rationale). The rationale may be drawn from a range of sources including research evidence, behaviour change theories, and local knowledge, or from primary research conducted as part of the intervention feasibility and piloting stage. Drawing on diverse sources of knowledge should yield a more plausible intervention with an increased chance of achieving its goal of improving the outcomes of those who receive it;

  3. 3 highlighting the key assumptions that set out the conditions that the causal pathway needs to achieve impact. Through this process, potential barriers and interventions needed to overcome these barriers can be identified so that the ultimate outcome can be achieved;

  4. 4 identifying indicators for each outcome in the pathway to evaluate whether each stage of the pathway leading to the final impact is achieved.

All these components are displayed graphically on a ToC map, often with an accompanying narrative that describes the pathways and key assumptions (as shown in Fig. 3.2). Further guidance and resources on how to develop a ToC are available via the Centre for Theory of Change (<http://www.theoryofchange.org/>).

Refining a ToC

Before an intervention is implemented, key aspects of the ToC should be tested in the feasibility and piloting phase of the MRC framework. This involves turning the assumptions articulated in the ToC into research questions to test in formative research. This may help reduce implementation failure as weak links in the causal pathway are tested and strengthened if necessary, leading to a revision of the intervention. The ToC is then modified to reflect changes resulting from the feasibility and piloting phase and a revised ToC is taken forward for formal testing in the evaluation phase. Developing a ToC must be a continual process of reflection and adaptation as barriers to implementation arise and new evidence comes to light, requiring the pathway to be changed and strengthened.

Evaluating a ToC

The evaluation of a complex intervention using a ToC approach involves identifying at least one indicator for every outcome within that framework to measure whether it has been achieved. Indicators must be specific enough to describe what change is necessary in the outcome to move up the causal pathway (e.g. how many people need to be trained with the appropriate level of competency in order to deliver the intervention as intended).

Evaluation using a ToC framework involves measuring indicators at all stages of implementation, not just an intervention’s primary and secondary outcomes. This includes a wider range of input, process, output, and outcome indicators than may normally be measured, with a clear focus on measuring whether key stages in the causal pathway are achieved. ToC allows for multiple outcomes of the intervention to be prespecified within a theoretical framework, thereby explicitly evaluating the multiple outcomes that complex interventions may lead to. As a result, an evaluation based on a ToC will require a number of different methods to capture all of the indicators.

Disseminating a ToC

Experience of implementation and evidence gathered from the evaluation is combined to revise the ToC and produce the final ‘story’ of how the intervention worked in a particular setting. This provides a comprehensive description of the intervention which can be disseminated to a variety of audiences, providing information on the active components of the intervention that need to be adapted for use in other settings. The MRC guidance calls for more detailed and standardized descriptions of complex interventions in published reports to facilitate exchange of knowledge and encourage synthesis of results from similar studies (17, 18). ToC may be a useful tool to meet this challenge.

Using ToC has a number of benefits, which improve the existing MRC framework for complex interventions, and include:

  1. 1 helping a diverse range of stakeholders reach a realistic consensus on what is to be achieved, how, using what resources, and under what constraints;

  2. 2 ensuring the intervention has the buy-in of stakeholders from the start and embedding the design in a real-world context, which increases the likelihood that it will be effective and subsequently scaled up;

  3. 3 providing an overarching theoretical framework incorporating formative, process, and impact evaluation research questions;

  4. 4 providing information about how and why an intervention works in addition to whether it works;

  5. 5 facilitating timely and informative information about the progress of the project which can be understood by a diverse range of audiences.

Figure 3.3 illustrates how using ToC strengthens each phase in the MRC framework. Used in conjunction with the MRC framework, ToC may be a useful tool to improve the design and evaluation of complex interventions, increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable.

Fig. 3.3 How ToC can be used to strengthen the MRC framework. (Adapted from Craig 2008 (17)).

Fig. 3.3
How ToC can be used to strengthen the MRC framework. (Adapted from Craig 2008 (17)).

Conclusion

In this chapter we discussed the nature of complex interventions and how mental health interventions are complex. We then described the need for a structured framework for developing and testing complex interventions and described the MRC framework, one of the most widely used frameworks for this purpose. Finally we focused on the treatment development phase of the MRC framework and illustrated the various steps in this phase using the example of a research project from Goa, India. Complex interventions are made up of a number of interconnected components, acting both independently and interdependently, a characteristic commonly seen in mental health interventions. Using a structured framework like the MRC framework and complementing it with other frameworks like the NPT and ToC helps to address the host of challenges inherent to the development, evaluation, and implementation of mental health interventions.

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