Chapter 8: Discussion, recommendations, and conclusion
8.6 Recommendations
The AFFIRM-SA RCT was conducted as a task-shared mental health intervention for women with perinatal depression in Khayelitsha. It was planned in 2010/2011 and implemented in 2013. While the findings from the process evaluation in this thesis are specific to the counselling sessions and qualitative data from the RCT, the lessons can be generalised. They have implications for future task-shared research interventions for mental illness in similar low- and middle-income settings, where poverty and inequality are some of the key and common driving factors for mental illness across these contexts. Once research is conducted that is responsive to local context, it is hoped that interventions can be more efficiently and effectively scaled up across public domains. The recommendations arising from this thesis are presented below.
Formative research
To begin with, extra time and budget needs to be built into conducting fully comprehensive feasibility studies before an intervention begins. These should go beyond the practicalities of research, toward asking the right questions and paying attention to what participants in each particular context might require (Bolton, 2019). It would also entail a review of the traditional and cultural strategies that are already being used, or have historically been used, in working with mental illness and mitigating isolation, in order to incorporate these into a culturally relevant intervention (Wampold, 2015). A comprehensive feasibility study could involve community-level participatory research, which would provide insight into the roles of both the community and the health system (Petersen, Baillie, et al., 2012).
Address contextual need
Thus, driven by the learnings from this study, in addition to working out the practicalities of implementing a trial, a feasibility study should include a deep examination of the localised understandings and causes of depression and mental illness (Chibanda et al., 2017). These should then be integrated into the intervention so that it is created in a format and design that is responsive to the needs of the population and is conducted in a culturally congruent manner (Wampold, 2015).
Throughout the intervention development and implementation, contextual influences need to be kept in mind, such as those described by Moore et al. (2015). These would include those that “affect (and may be affected by) implementation, intervention mechanisms and outcomes, and causal mechanisms present within the context which act to sustain the status quo, or enhance effects” (p.24). These contextual factors need to be used and acknowledged when designing the theory of change model for the intervention. An understanding
165 of the structural systems in which the women are located should therefore be developed (Burgess et al., 2020).
Then, in collaboration with the women themselves, mechanisms should be identified that would help them to cope with the symptoms of depression, as well as with the adversities that they face.
If interventions are using previous evidence-based modalities, it is vital to adapt them to local needs. Bolton (2019) recommended various steps in the adaptation process that involve: preliminary understanding of local priority mental problems, selection of treatment approach, conversion of manual and training materials into simple language, translation of the manual and training materials into local the language, on-site provider training, piloting, and on-going adaptation.
Responsive research
The above points emphasise the importance of developing manuals, materials and processes in collaboration with all stakeholders. This should be done through initial participatory research, piloting, and testing manuals and interventions, and finally retrieving feedback from counsellors and participants so that it is better embedded and appropriate and integrated into the context and community.
This can be done through an adaptive and iterative approach, conducting continuous process evaluations and involving constant feedback even during the implementation of research trials (Michelson et al., 2020).
Importantly, these evaluations need to be budgeted for and included right from the beginning stages of research proposals and grant writing, with funders building in expectations of this process.
Therapeutic elements in the intervention
Following intensive feasibility research, the design of the intervention should include the use of common factors or non-specific elements that have been identified in international literature and in local studies, if these are available (Cuijpers et al., 2019; Murray and Jordans, 2016; Singla et al., 2017). Examples from AFFIRM-SA include establishing a sense of trust, creating an environment that fosters problem sharing and a willingness to talk openly to someone, experiencing a sense of relief, increased awareness and education, normalisation, social support, and a feeling of connection. Others identified by Singla et al. (2017) include eliciting social support, communication skills, emotional regulation, emotional processing, collaboration, empathy, active listening, normalisation, and involvement of a significant other. CHWs and counsellors need to be trained in these ‘common therapeutic factors’ that should then serve as the basis or foundation for all psychological treatments, regardless of modality (Singla et al., 2017).
166 Following this, the intervention could then include elements of mental health promotion through evidence- based modalities such as problem solving or CBT, IPV reduction, and economic skill-building components and/or cash transfers. The mental health component should involve only one therapeutic modality (for example, as used by Rahman et al. (2008) and Patel et al. (2017)). In this study, the problem solving modality seemed to be most appreciated, and this came second to the therapeutic elements in the sessions such as the connection with the counsellor and a feeling of alliance and support. Using only one therapeutic modality would allow counsellors to become more familiar with this approach, thus growing their confidence and competence. Based on AFFIRM-SA feedback, there should also be the provision or opportunity for more than six sessions of counselling.
Design of the manual
For CHWs who are not professionally trained in therapy nor necessarily highly literate, manuals need to be clear and simply worded, with obvious distinctions between what is supposed to be read out loud and the instructions meant to guide the counsellors (Bolton, 2019). Ideally, the manual should only be written in one grammatical style. It should either be extremely explicit with decisive instructions guiding counsellors to follow every step, or a great deal more open, with only a few key pointers about the topic of the sessions. The latter approach would be more reliant on counsellors having learnt the basic counselling techniques, skills and content required for each session (as used by Rahman et al. (2008) for example).
Piloting
Once an intervention is initially developed, it should be fully piloted, and feedback on content and implementation should be elicited from CHWs and participants alike. The design of the trial should be open and use an iterative process so that feedback can be incorporated and then tested again, once it has been incorporated. This would involve the inclusion of constant process evaluations to assess mechanisms of impact, such as participant and counsellor responses to the intervention, potential mediators, and unanticipated pathways and consequences (Moore et al., 2015). By conducting thorough feasibility and piloting, the assumptions created in the intervention theory of change model can also be tested and modified. The trial design needs to be flexible enough that implementation processes can be shifted should this be necessary.
Training
Given that the AFFIRM-SA trial had only one week of training, and that other interventions have provided training for up to one month (Singla et al., 2017), a key recommendation from this study is that training for CHWs is conducted over at least three weeks, and that refresher training sessions are conducted throughout the intervention. Training for CHWs to become mental health counsellors needs firstly to embed the
167 knowledge, understanding and practice of common therapeutic elements (Kohrt et al., 2015; Singla et al., 2017). Once these are internalised, training can continue around understanding the psychological concepts behind the chosen modality, and then how to follow and use a manual. Petersen et al. (2014) recommend using standardised training models with simple counselling guidelines for both behaviour change and psychosocial problems. Budgeting for this extended period of training needs to be encouraged and expected by funders and should be included in all funding proposals.
Competency
CHW’s therapeutic competence and ability to follow a manual needs to be assessed before they are employed on a project requiring them to conduct counselling. Standardised role plays may be used to assess this such as the ENACT and EQUIP tools (Kohrt et al., 2015; Kohrt et al., 2020). In addition, CHWs should ideally hold some basic interest or inclination in mental health and counselling and have a desire to help those with mental illnesses (Spedding, 2017).
Supervision
Intricately linked with training is the provision of regular and thorough supervision for CHWs. This would involve not only case management but also an in-depth examination of counselling style, rapport with participants, and understanding of psychological concepts (Barnett et al., 2018; Myers et al., 2019). Supervision needs to ensure that the CHWs can apply the psychological concepts they are using consistently across different participants (Barnett et al., 2018). AFFIRM-SA data shows that this should also involve the supervisor sitting in on initial sessions and at regular intervals throughout the intervention, as well as consistently listen to audio recordings of the sessions.
Supervision may be enhanced through the use of peer supervision, objective counsellor self-report forms, live observation of sessions, and role-play behavioural rehearsal (Murray et al., 2011). Throughout the process, CHWs need to be empowered so that they feel able to give feedback and suggestions on content and implementation of the intervention to ensure that it is congruent with local expectations, context and capabilities (Chibanda et al., 2017).
Last, given the potential for burnout and drop in efficiency of CHWs who work continually with psychosocially disadvantaged people, external support and monitoring mechanisms should be mandatory for them (Barnett et al., 2018).
168 Support for the supervisor
Similarly, the clinical supervisor needs to be provided with training in supervision skills and receive regular supervision and support (Barnett et al., 2018). This should include the awareness and support around the fact that the supervisor often has to play the role of ‘cultural broker’ between CHWs and investigators. Employing more than one supervisor in an intervention may be a means to prevent burnout and overload for supervisors (Myers et al., 2019).
Assess mechanisms of change
Process evaluations should be conducted throughout an intervention (Murdoch, 2016). Feedback on these evaluations should become a requirement for trials (Bauer, Damschroder et al., 2015), in order to increase the amount and flow of information around what works and why it works, rather than simply whether it works (Cuijpers, 2019). It is only through consistent and ongoing assessment and reporting of these mechanisms across trials that we can start to learn what elements are essential in improving mental health, how these elements can be replicated, and what can be improved (Cuijpers et al., 2019).
Where possible, interventions should set up systems that are able to assess causal links between therapeutic elements and treatment outcomes (Cuijpers et al., 2019), and to analyse moderators, mediators and cost effectiveness to identify the variables that contribute to the most effective changes and outcomes in task- shared psychological treatments (Singla and Hollon, 2020).
Funding and compensation for CHWs
Interventions to address mental illness need to be sufficiently funded so that appropriate training, supervision and compensation may be provided for CHWs, in the recognition that they are the key players as the core providers of mental health services (Esponda et al., 2020). In this regard, task sharing should be viewed from the perspective of increasing coverage of care rather than of saving money.
Reporting
Last, it is vital that all stages and processes of task-shared research be reported, including the training, supervision, and intervention development processes (Damschroder et al., 2009). Feasibility studies should be reported alongside trial outcomes, so that feasibility and acceptability is more fully realised than only through a pilot study (Hoddinott, 2015). For randomised controlled trials and their pilots, the Consolidated Standards of Reporting Trials (CONSORT) guidelines should be used (Schulz, Altman et al., 2010).
169 In conclusion, the AFFIRM-SA RCT has shown that task-shared interventions for mental health in LMICs need to be more responsive to the contextual drivers of depression. They should include a limited number of therapeutic elements or mechanisms of change that are locally feasible and acceptable. Adequate training and supervision are essential for success. Once these interventions are tested in pilot studies, they may be evaluated in fully powered RCTs.