Title: DeCoDer TrialDebt Counselling for Depression in Primary Care: an Adaptive Randomised Controlled Trial.
Funder: Department of Health (England)

Abstract: Our proposed randomised pragmatic adaptive trial compares: debt advice counselling within a collaborative biopsychosocial approach plus NICE recommended treatment as usual (TAU); versus TAU plus a debt management advice leaflet; for patients located in Primary Care with depression or mixed depression & anxiety. Our multicentre trial will recruit populations across the range of deprivation levels & practices. We will recruit from GP lists & waiting rooms The trial protocol will be refined with patient & public involvement (PPI) within COMET Initiative. We will co-develop the intervention with Citizen’s Advice Bureau (CAB) senior managers & PPI advisors. Our adaptive design extends the feasibility approach to robustly monitor recruitment test cluster versus individual randomisation assess sample size assumptions check treatment adherence & fidelity. We will also explore explanatory models influencing outcome using psychometrics & qualitative in-depth interviews. Design: Two phase adaptive pragmatic RCT with 1:1 allocation to intervention or control. Setting: GP practices in Liverpool Cheshire Plymouth & Swansea extending to neighbouring areas if required to achieve recruitment. Target Population: Patients with Depression or mixed Anxiety & Depression who are currently depressed (BDI>13) & consider themselves to be experiencing financial problems will be recruited from practices across urban to rural areas (50% from lowest deprivation quartile) through targeted GP invitation letters from list searches or waiting room recruitment. Health Technology being assessed: Collaborative Primary Care orientated debt counselling & advice by senior trained CAB advisors linked to practices with shared comprehensive assessment & formulation (GP/Patient/CAB worker) in addition to NICE informed TAU. Comparator: NICE informed TAU plus debt advice leaflet. Cost and outcomes: Primary outcome – depression (Beck Depression Inventory [BDI]). Secondary outcomes: wellbeing (short WEMWEBS) NHS/social services utilisation & costs (Adapted Client Service Receipt Inventory Stanford Presenteeism scale & FitNote/absenteeism self-report) anxiety (Beck Anxiety Inventory) debt assessment & progress (measurement developed in pre-grant phase with CAB/PPI) health–related quality of life (MANSA & EQ5D5L) service satisfaction (GSQ). Life events (LED-S) Hopelessness (BHS)rumination (RSQ) & attributional style (ASQ) will be included as potential mediators for modelling & theory building. Outcomes will be assessed at baseline then 4 & 12 months post-randomisation. Qualitative design & Process evaluation: In feasibility & full RCT we will undertake baseline & post intervention qualitative interviews exploring with participants: recovery factors biographies & ethical issues-analysed using a narrative approach; & assess adherence to intervention (staff/participants) using Normalization Process Theory (NPT).Assess commissioners willingness to commission the service: we will recruit commissioners providers & other key stakeholders to a virtual group to advise us on cost-effectiveness measures that will most influence their decisions & then review our findings with them at the end of the feasibility trial. Sample Size: 135 per patients/arm gives 90% power to detect a clinically meaningful difference of 3.5 BDI units between groups at 5% two-sided alpha (based on standard deviation of ~9). To allow for a cluster allocation we would need to inflate the sample size (e.g. a design effect of 1.45 for an intracluster correlation coefficient of 0.05 (likely to be lower) & cluster size of 10). Allowing for 20% attrition & feasibility trial clustering effect 195 patients/arm overall need to be recruited if we use individual randomisation in the full trial but this will be 235 per arm if we cluster randomise throughout. In feasibility RCT we propose to recruit & randomise 120 patients to intervention & control groups nested by individual or cluster randomisation.Intervention: Controls will receive NICE Guidance informed treatment for their depression from GP &/or IAPT services plus a debt advice leaflet prepared in collaboration with CAB. Intervention participants will see a Primary Care based CAB advisor & their GP who will complete a shared comprehensive assessment at their respective appointments. CAB will then offer up to 4 appointments with a debt advisor in their Primary Care-based service.Project Plan:Pre-grant -3 to 0mths: COMET Initiative-informed approach to finalising data collection packs (quantitative & topic guides) with PPI/CAB consultants including developing & adapting process measures & debt monitoring informed by brief literature reviews; preparation of recruitment & intervention materials. Complete IRAS & governance applications. Select pilot recruitment site practices. Recruit research staff (2 years initially to end of feasibility then review whether we proceed to full RCT) & CAB counsellors into study. Setup phase 0-4mths: Co-development of manualised intervention GP briefing sessions about TAU & joint comprehensive assessment. Organise final permissions service support costs & initiate preliminary list searches & mailings. Feasibility RCT 4-14mths: Allocate practices to intervention & control using cluster or individual randomisation. Participant recruitment screening & baseline (6-mths) 7-12 from each of 4 practices in 3 areas; monitor baseline data for case mix severity acute v chronic/recurrent & associated risk factors for debt & depression. Set up & test economic data collection systems Undertake 4 month follow-ups. At the end of feasibility we will check for evidence of contamination rate of recruitment & BDI SD in order to inform the design of full RCT according to our Stopping & Design Change rules as outlined in more detail elsewhere. We will undertake purposively sampled qualitative interviews (~40) using narrative approach to understanding debt biographies & NPT for treatment fidelity using constant comparative data analysis with PPI input. Full RCT: 15-39mths- All practices either cluster or individually randomised according to feasibility evidence of contamination. Recruitment (mth 15-27) data collection at 0/4/12 mths plus qual interviews. Final analyses Knowledge Translation Events & Dissemination: 39-45mths- Statistical economic & qualitative analyses writing papers presenting findings preparing for implementation.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH