DeCoDer trial

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.

Trial design

The study is an adaptive parallel two group pragmatic randomised controlled trial with 1:1 allocation to intervention or control with a nested mixed methods process and economic evaluation. Patients who have current depression and are worried about debt will be recruited through general practices in three areas of UK. After screening and consent, participants will be randomised to receive either General Practice treatment as usual (TAU) supplemented by a debt management advice leaflet (control group) or General Practice treatment as usual supplemented with a debt management advice leaflet and primary care based CAB debt advice including a shared GP/Advisor comprehensive assessment (intervention group). Primary (Beck Depression Inventory) and secondary (health-related quality of life, cost effectiveness, satisfaction, and explanatory factors) outcomes will be assessed in all participants at baseline, 4 and 12 months. In addition, qualitative in-depth interviews will be undertaken, to explore causal models of how debt counselling works.

The study includes an internal pilot phase in which intervention fidelity will be assessed and implementation problems identified and resolved without change to the intervention, so that data collected in this phase can be used in the final analysis. Both individual and cluster randomisation methods will be used in the pilot phase to assign participants to intervention or control arms with the aim of using individual level randomisation in the main trial if the pilot phase shows no strong evidence of contamination

Timeline

Phases: set up phase (months -3 to 0)

This phase will include detailed theoretical modelling of the intervention based upon the existing systematic review literature on collaborative care and social prescribing, supported by knowledge from the evaluation of the Liverpool CAB primary pilot.

Months 1-4

The intervention will be implemented in one practice per each site (possibly those where RB and MG currently work), focussing on use of the joint formulation. Detailed quantitative and qualitative process data will be collected using telephone and face-to-face interviews at each site and data recorded by the CAB workers in each practice with a small number (5-10) pilot participants. The model will be refined and manualised and a training programme developed for CAB workers and GPs. We will also finalise organisational agreements between CAB and practices. Fidelity assessment procedures (intervention by CAB, GP TAU and shared comprehensive assessment) will be developed during this stage.

Months 4-15, feasibility trial and review

The intervention will be implemented utilising manuals, training and organisational agreements developed above. Fidelity will be assessed and qualitative interviews will be used incorporating the Normalisation Process Theory to assess implementation problems and facilitators and resolve these to ensure the intervention is implemented as closely to the model as possible. Refinements to training and the manual may be made to help ensure fidelity to the original model. The original model itself will not be changed so as to enable the feasibility trial participants to be included in the full dataset (i.e. the feasibility trial will act an internal pilot for the main trial).

Full trial months 16-39

The intervention will continue to be implemented with any additional procedures developed in the feasibility trial to ensure closer fidelity to the model. 

At the end of the internal pilot trial, recruitment methods, acceptability of the intervention, attendance rates at advice sessions and willingness of commissioners to continue the CAB service will be assessed.

DeCoDeR intervention

The trial intervention brings together two existing services:

1) Debt counselling provided by third sector providers e.g. the Citizens Advice Bureau.

2) Primary care mental health services provided by general practices, supplemented by Improving Access to Psychological Therapies (IAPT) Services in England, and a variety of counselling and psychological therapies services in Wales. 

This combined assessment will combine social, psychological, environmental, economic and medical perspectives in a formulation which will incorporate personal goals and a bio-psycho-social management plan. The intervention as a whole will incorporate four organisational mechanisms to optimise utility of the comprehensive assessment and the debt counselling.

Overview

Title Debt Counselling for Depression in Primary Care: An Adaptive Randomised Controlled Trial
Study location Primary care settings in England and Wales (lead site Liverpool)
Study 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
Study design Adaptive parallel two group multi-centre randomised controlled trial with nested mixed methods process and economic evaluation. An internal pilot phase will be used to check intervention fidelity and need for cluster randomisation
Planned number of sites 3 (Liverpool/Cheshire, Plymouth, Bridgend)
Study population
Main inclusion criteria  Age ≥18; Scoring ≥14 on the Beck Depression Inventory; Self-identifying as having worries about debt
Main exclusion criteria Housebound and/or unable to get to CAB advice sessions; actively suicidal or psychotic and/or severely depressed and unresponsive to treatment; 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
Planned sample size 195 patients/arm across both feasibility and main trials if single randomisation or 235 patients/arm across both feasibility and main trials if cluster randomisation
Study intervention
Control arm Debt advice leaflet provided by GP and treatment as usual (TAU)
Trial intervention Debt advice leaflet provided by GP, debt counselling advice from a Citizens Advice Bureau Advisor and TAU
Summary of outcome measures
Primary Beck Depression Inventory II
Secondary Beck Anxiety Inventory (BAI), short form of the Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS), EQ-5D-5L, Manchester Short Assessment of Quality of Life questionnaire (MANSA), adapted version of the Client Service Receipt Inventory (CSRI), Stanford presenteeism scale, general satisfaction questionnaire (GSQ), short Life Events and Difficulties Schedule (LED-S), The Adult Hope Scale, , Response Style Questionnaire - 24 (RSQ-24), Other as Shamer Scale (OAS), alcohol use Audit questionnaire, substance misuse screening tool (DAST)
Study schedule
Duration of study 45 months
Study timelines Set-up 3 months. Internal pilot 11 months. Full trial 25 months. Data cleaning, analysis, reporting 6 months. Total duration 45 months
End of trial Completion of last follow-up visit of last participant

The team

This project is led by Professor Mark Gabbay at the University of Liverpool with Professor Richard Byng as a co-applicant from Plymouth University Peninsula Schools of Medicine and Dentistry. Further co-applicants include Professor Michael King from UCL, Professor Rod Taylor from UEMS, Professor Carl May from University of Southampton and Professor Peter Huxley and Professor Ceri Phillips from Swansea University.

Key contacts at Plymouth include:

Trial email: decoder@plymouth.ac.uk

This project is supported by the NIHR Collaboration for Applied Health Research and Care South West Peninsula (PenCLAHRC).

Partners

Funded by the NIHR

Debt resources

  • Study debt leaflet
  • RC Psych leaflet
  • 2x practitioner leaflets