Title: *M*ulti-morbidity in *O*lder Adults with *D*epression *S*tudy (MODS)
Funder: Department of Health and Social Care

Abstract: Aim. Develop a feasible, acceptable, clinical and cost-effective intervention to improve physical and mental functioning in older adults with mental-physical multimorbidity including depression. Objectives: 1. Develop a feasible collaborative care intervention for older people with depression and long term conditions (LTCs). 2. Conduct an external pilot trial to establish trial procedures and refine our intervention for the target population. 3. Conduct a fully powered, definitive trial of the clinical effectiveness and cost utility of the intervention. 4. Develop a framework to inform post-trial implementation of the intervention across provider settings and staff. Rationale Multimorbidity in older people is a clinical priority with complex but adaptable interventions required to offer effective treatment across the care pathway. In response to this priority, we propose the multimorbidity in older adults MODS programme of research. We will develop and evaluate an intervention which addresses the co-existence of the most common mental disorder (depression) alongside physical ill health. Depression and long term conditions (LTCs) commonly exist together; the outcome of LTCs is worse if depression is present [1]. We have promising evidence that by offering integrated physical-psychological care, depressive and functional symptoms can improve. We propose to refine and evaluate the use of collaborative care and a brief psychological intervention (behavioural activation) for older people with mental-physical multimorbidity drawing upon our prior research (trials and systematic reviews) in this area. Our programme follows the MRC complex interventions framework [2]. We will adapt and refine a complex intervention (with an already-established randomised evidence base) for use in a new population (older adults with mental-physical multimorbidity). WS1 Adapting and developing the collaborative care/behavioural activation intervention for people with mental-physical multimorbidity Collaborative care with behavioural activation has a robust evidence base amongst older people with depression. We will iteratively adapt our existing self-help materials from earlier trials for older people with depression using a mix of interviews, consensus groups and case studies. Our intervention is based upon a well-evidenced, theoretically-informed behavioural intervention delivered within a collaborative primary care framework. We will develop a manualised treatment protocol with training materials/programme. WS1 output: A manualised collaborative care intervention that addresses functional limitations and depressive symptoms amongst older people with mental physical multimorbidity. WS2 MODS external pilot-trial with concurrent qualitative evaluation Having developed our collaborative care intervention, we will conduct a pilot study to ensure our materials and the interventions are fit for purpose [3] to deliver a complex intervention to our target primary care population with mental-physical multimorbidity. We will use a stand-alone external pilot-RCT to assess optimum methods of recruitment, retention and intervention delivery. WS2 outputs: (1) the final manualised collaborative care behavioural intervention which is fit for purpose , (2) clear parameters and procedures to enable the MODS programme to conduct a fully-powered trial of clinical effectiveness and cost utility. WS 3 MODS pragmatic randomised controlled trial In a fully powered trial we will establish the clinical effectiveness and cost-utility of a collaborative care intervention for older people with physical-mental comorbidity. We will use a pragmatic design to ensure maximum generalisability to real world primary care settings. We will use a patient reported outcome measure (PROM) as our primary outcome, in order to judge the value of collaborative care results in terms of changes in level of physical and mental function. We will recruit a minimum of 572 participants to detect a medium effect sizes at 12 month follow-up. We will conduct a concurrent economic evaluation from an NHS and social care perspective to establish the cost utility of our intervention. In addition we will conduct a model based economic analysis due to the substantial and increasing cost of providing care to this population. WS3 output: We will provide a scientifically-robust estimate of the clinical effectiveness and economic evaluation of collaborative care for older people with mental physical multimorbidity. WS4 implementation framework development Translating trial evidence into everyday practice is challenging, especially in the context patients with mental-physical multimorbidity whose healthcare is provided across different sectors and different health professionals. We will use quantitative and qualitative methods to identify and evaluate processes and mechanisms that underpin intervention delivery, with a focus on understanding connections between programme inputs and outputs over time and across contexts. The evaluation will be guided by use of programme theory and a logic model to identify and assess the relationships between intervention components and outcomes. WS4 output: Data linked to understanding barriers and drivers of intervention implementation. A comprehensive implementation framework for use by stakeholders with interests in the provision/commissioning of interventions for older adults with mental-physical multimorbidity. The results of our research will be generalisable to a wide range of NHS patients and across a range of NHS settings, and will have the potential to improve care for older people with mental-physical multimorbidity and ensure that NHS care is maximally effective and efficient.

Lay abstract: Background People with long term physical conditions are more likely to experience depression. When these problems exist together they reduce quality of life for the patient and can be very costly to health and social care services. We aim to establish if a treatment for these difficulties is effective and good value for money. We will focus on older adults who have depression and two or more long-term physical health problems (i.e. diabetes, asthma, heart disease). We want to look at whether a talking treatment treatment called Behavioural Activation can help improve a person s physical and psychological functioning, for example self-care and mood. Behavioural Activation helps people look at the link between what people they do and how they feel, and then what changes they can make to improve their health and wellbeing. This will be be provided within a care framework that supports a case manager (such as a nurse) to work with the patient and other health professionals so treatments are delivered in the most effective patient-centred way, called Collaborative Care. How will the study be carried out? We first develop a new treatment by talking to older adults with experience of low mood symptoms and physical health problems and health care professionals. From this we will develop training and develop materials and deliver the treatment to small groups of people in succession. Based upon observations/feedback we will refine the treatment. We then conduct a small trial of the intervention to check we can recruit to the study and follow people up and further refine the intervention. We then conduct a larger trial to compare the intervention to the usual care people would receive and look at its effect on improving health and functioning. Which person gets what treatment will be chosen randomly. We will also check the value for money the treatment may provide for the NHS. If the intervention works we will tell NHS staff how best to use it across settings such as primary care, psychological therapy services and in hospital medical services. Involvement of patients and the public We will work closely with older adults who have experienced low mood and physical health problems in developing the intervention. Throughout the study, a group of older people with lived experience of depression and long term conditions will advise us. This will ensure that patient views are represented increasing the chances of this research being successful. How will we tell people about the results of the study? The results will interest different groups, including older adults, GPs, commissioners and policy makers. With our partners Age UK we will talk to people from each of these groups about our results and develop training materials for the NHS.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: GENERIC HEALTH RELEVANCE;MENTAL HEALTH