This randomised controlled trial explores whether debt advice provided by Citizens Advice Bureau (CAB) counsellors for patients with debt and depression, accessed through general practices, makes a difference to their recovery.
Background
Depression is estimated to affect 5-10 per cent of adults at any one time, and is a common presentation in Primary Care. However, research suggests that only around 2.5 per cent of patients are formally recorded by GPs as having active depression or depressive symptoms. Alongside anxiety and stress it is considered the commonest cause for prolonged work absenteeism, as well as presenteeism (working below normal capacity when unwell). Mental ill health is estimated to cost the UK economy £40B per year overall. Around 11 per cent of the population are estimated to be struggling with personal debt, with evidence of increasing episodes of suicide associated with rising debt. There are concerns that this situation may worsen the deteriorating economic situation.
Most episodes of depression are managed in Primary Care, following the NICE recommended four-stepped approach. This includes a range of low intensity interventions including; short-term talking therapies, social prescribing to support lifestyle changes (e.g. for exercise), and antidepressants for more persistent symptoms. A recent HTA trial found a marginal benefit of SSRIs (antidepressants) for new cases of mild-moderate depression managed in Primary Care over treatment as usual (TAU), but many questions about the most cost effective ways to manage depression remain.
Recognising the increasing burden of indebtedness and the link between debt and mental illness in the Foresight Report, the UK government provides web-based advice and guides on debt-management highlighting a range of providers. Topping this list is the Citizen’s Advice Bureau (CAB), a charity-based service which is widely available across the UK in over 3,500 locations, providing support to over 2M people per year. Their principal on-line recommended site is provided by government, funded by statutory levy from the financial services industry, backed by a national advertising campaign: the Money Advice Service website at www.moneyadviceservice.org.uk. Unfortunately, those with depression, particularly if from socio-economically deprived groups, may be particularly likely to find on-line services insufficient or inaccessible (due to travel costs and/or low mood). As a result, a locally accessible, nationally provided advice service may be an important alternative. Debt is more common among poorer populations and around one in four among those experiencing mental health problems, who make up 50 per cent of those with debt overall. The strategic and economic cases for providing debt advice for people experiencing mental health problems have been made in recent influential reports; and the intervention being proposed here falls within the suggested service provision costs and model. This study explores an intervention designed to provide enhanced access to timely support for people with depression and anxiety about indebtedness, and will provide robust information on its cost effectiveness and acceptability.
Who is it for?
Patients with a history of depression (with or without anxiety) within the last 12 months and who are worried about personal debt will be recruited through participating GP practices at the study sites. Depression at screening will be classified according to the Beck Depression Inventory (BDI) score where 14-19 = mild depression, 20-28 = moderate depression, >28 = severe depression.
Inclusion criteria
- age ≥18
- scoring ≥14 on the BDI
- self-identifying as having worries about debt.
Exclusion criteria
- housebound and/or unable to get to CAB advice sessions
- actively suicidal or psychotic and/or severely depressed and unresponsive to treatment
- unlikely to comply with the intervention or follow-up e.g. experiencing severe problems with addiction to alcohol or illicit drugs
- unable or unwilling to give written informed consent to participate in study
- currently participating in another research study including follow-up data collection phase
- has received CAB debt advice in the past 12 months.
Aims and objectives
Main aim:
To determine the clinical and cost effectiveness of the addition of a Primary Care debt counselling advice service to usual care, for patients with depression and debt.
Specific objectives:
(i) To compare depression between intervention and treatment as usual groups.
(ii) To compare anxiety, mental wellbeing, debt/financial status, satisfaction, health-related quality of life and societal costs between intervention and control groups.
(iii) To explore outcomes referred to in (i) and (ii) in terms of the following potential predictors - substance misuse problems, self-esteem, life events and difficulties, hope, optimism, resilience, and attribution style.
(iv) To determine core outcome domains and measures using the COMET Initiative approach to define a Standard Outcome Measure for mental health trials in deprived and hard to reach groups in primary care, adapted to this specific study.
(v) To manualise debt assessment and counselling intervention & joint comprehensive assessment (GP/patient/CAB) for use within the intervention.
(vi) To recruit new and chronic/recurrent cases from a variety of practices and populations to enhance generalisability.
(vii) To undertake a mixed method process evaluation to assess fidelity of intervention (using Normalisation Process Theory) and explore reasons for outcome differences and relationship between depression, anxiety, debt, stigma, shame and psycho-socio-economic factors triangulating economic, psychological factors analysis and qualitative interview data.
(viii) To undertake Knowledge Exchange events to inform adoption into care pathways (implementation).
(ix) To work closely with Service Users in Research/Patient and Public Involvement groups across the study sites to inform trial methodology, intervention development, aspects of analysis and the implementation of preparatory work.
(x) To recruit a virtual group of commissioners, providers and Health and Wellbeing board members to check willingness to commission intervention and advise on domains and measures.
(xi) To work with CAB leads, GPs and PPI advisors on developing the intervention and comprehensive assessment, qualitative topic guides and aspects of data analysis.
Pilot aim:
The aim of the internal pilot phase is to test the procedures, recruitment processes and operational strategies that are planned for use in the main trial, identifying and resolving any problems and thereby assessing the feasibility of continuing with the main trial. Specific objectives are:
1) to confirm methods for recruitment of practices
2) to confirm the ability to recruit patients via the proposed approaches
3) to confirm the acceptability of the study interventions
4) to confirm acceptability of data collection (outcome measures)
5) to assess contamination and confirm the randomisation method for the main trial
6) to assess the level of participant attrition
7) to check robustness of data collection systems
8) to identify and resolve potential difficulties in implementing the shared assessment to assess intervention fidelity.