Integrating Behavioural Activation and Physical Activity promotion (BAcPAc): A pilot randomised controlled trial with depressed patients

Depression is a leading cause of disability worldwide, and by 2020 is expected to become the second most debilitating of all general health problems. It places significant emotional and practical demands upon patients, impacts upon all aspects of daily life and consequently reduces quality of life. These costs and impact pail into insignificance however when, as a consequence of sustained inactivity which is a main symptom of depression, patients are also placed at an increased risk of a wider range of health related difficulties such as obesity, diabetes, and stroke. Despite such well established links between depression, reduced activity and physical health, interventions tend to target each of these areas individually, with little guidance available on how best to promote physical activity within mental health services.
The main aim of this proposal is to address this limitation by enhancing behavioural activation, an evidence based psychological intervention for depression and recommended by NICE (2009), by adding a focus on techniques that are used to encourage physical activity to develop a single intervention capable of reducing depression whilst at the same time increasing physical activity. This research approach follows the latest guidance highlighting the way to undertake research to develop interventions. To reduce the likelihood that research programmes will fail to meet their objectives such guidance proposes that prior to a large and expensive research study being undertaken to address the effectiveness of the intervention, researchers should seek to undertake a smaller pilot study to inform the development of the larger study and identify if the larger study is feasible. In line with this approach this research proposal will consist of two main phases both of which include the following specific objectives.
Phase I: (a) Using service users and experts in physical activity promotion to identify suitable physical activity behaviour change techniques (e.g. goal setting, self-monitoring through pedometer) to develop the enhanced BAcPAc intervention; (b) Inform the development of a training programme to develop competency in the workforce to support BAcPAc; (c) Identify the factors that may prevent BAcPAc being adopted by mental health services.
The knowledge collected during Phase I will then contribute towards meeting the Phase II objectives which are to: (a) use BAcPAc as the basis of a pilot randomised controlled study based within primary care to provide us with enough information to clarify uncertainties in the design and delivery of a large, more definitive study; (b) Assess the acceptability of the BAcPAc intervention amongst participants with depression.
The main application of the results from the study will be to inform the further development of a larger randomised controlled trial to examine the effectiveness and cost effectiveness of the BAcPAc intervention for increasing and maintaining physical activity in patients recovering from depression. Were this intervention to demonstrate effectiveness then the BAcPAc intervention would make a significant contribution to the range of evidence based interventions for people available for people with depression. Not least, were effectiveness to be demonstrated in the full study the BAcPAc intervention could be considered for inclusion within the NICE guidelines for depression. Such a recommendation would support widespread implementation of BAcPAc across England and provide patients with an evidence based intervention that not only addressed depression but also improved physical health outcomes.

Phase I objectives will be as follows: (a) Involve service users and experts in physical activity (PA) promotion to identify how best to enhance a routine, evidence-based behavioural activation (BA) treatment for people with depression by adding a focus on PA behaviour change techniques in a novel intervention (BAcPAc) within the Improving Access to Psychological Therapies (IAPT) programme; (b) Develop a training programme for the Psychological Wellbeing Practitioner workforce to support the BAcPAc intervention; (c) Identify service level factors that may impact upon the implementation of the BAcPAc as part of the IAPT programme; (d) Identify appropriate process measures sensitive enough to differentiate between BA alone and BAcPAc.
Phase II objectives will be as follows: (a) Undertake a pilot RCT of BA alone v. BAcPAc to confirm feasibility and clarify uncertainties in the design and delivery of a Phase III RCT; (b) Assess acceptability of the BAcPAc intervention among patients with depression.
The RCT will involve 80 patients with moderate to moderately severe depression, recruited through primary care in Devon. They will be randomised to receive either routine BA therapy or BAcPAc in the form of weekly sessions for up to 12 weeks. Measures of PA, symptoms of depression, self-reported sleep, health related quality of life, health and social care service use, blood pressure and body mass index will be taken at baseline, 4, and 12 months from both arms.
The results will: (a) inform the design of an appropriately powered Phase III RCT to examine the effectiveness and cost effectiveness of the BAcPAc intervention for increasing and maintaining PA in patients recovering from depression; (b) inform the development of a training programme to enable the PWP workforce to support PA promotion as part of the BA protocol; (c) contribute to current debates about enahncing competencies associated with the PWP workforce to promote physical health.

This proposal represents an opportunity to integrate physical activity (PA) promotion with behavioural activation (BA) to reach patients with depression who may have the most to benefit from doing more PA. To date there has been very little research to achieve this aim, with the separate disciplines involved remaining largely independent. A considerable impact arising from this proposal is therefore the way in which it brings together separate disciplines and accordingly separate theoretical literatures. In doing so the approach begins to combine research theory and practice from a diverse range of perspectives including PA and health, exercise and health psychology, mood disorders, behavioural medicine, clinical psychology, primary care, health economics and health services research.
Results of the research would therefore have a significant impact upon the academic community, and potentially begin to foster an enhanced multi-disciplinary understanding and approach to the study of health behaviour change and mental health. However the impact of the results can be seen to extend far beyond simply the academic community, to include policy makers, the mental health workforce and indeed patients who may be receiving the adapted BAcPAc intervention. The study has been contextualised as being implemented as part of the Improving Access to Psychological Therapies (Clark et al, 2010) programme. This programme, released across England in 2008, has been implemented to revolutionise the delivery of mental health services within primary care for people with mild to moderate high prevalence mental health difficulties. The main aim of the programme is to increase access to the range of evidence based psychological therapies as highlighted through the NICE guidelines with the delivery protocols and training programmes associated with the IAPT programme established to be responsive to updates to the NICE guidance. A significant impact of the research proposal would therefore be to inform the NICE guidance and subsequently for the BAcPAc intervention to be implemented into the IAPT programme. The potential for this impact is enhanced given the national roles that several members of the research team have within the IAPT programme, in particular involved with updating the IAPT national training curriculum for the Psychological Wellbeing Practitioner workforce (Department of Health, in press). Being established as an evidence based intervention within IAPT would also significantly impact upon the delivery of patient care. At present psychological interventions for depression are generally targeted specifically at reducing depression, regardless that depression is commonly comorbid with a range of physical health problems, such as obesity, diabetes and stroke. Developing the combined BAcPAc intervention would potentially impact on patient care by improving not only depression, but also increasing PA and potentially reducing depressive relapse.
Achieving these outcomes would have the potential to contribute to the nation's health and wealth in a number of ways. With regards to the nation's wealth the combined BAcPAc intervention has the potential to help reduce depression, maintain the benefits of depression and improve the general health of the patients undertaking the intervention, therefore making significant contributions to quality of life. In turn there are potential wider benefits arising from the BAcPAc intervention for the nation's health by reducing the incidence of co-morbidity between depression and other physical health conditions. Achieving these outcomes could result in significant savings to the costs of providing healthcare to the target population, a target shared by the wider IAPT programme.