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  • Gabbay M.B.
    Manchester University
  • Adele Ring
    University of Liverpool
  • Richard Byng
    Plymouth University
  • Pippa Anderson
    Swansea University
  • Rod S. Taylor
    University of Exeter Medical School
  • Caryn Matthews
    Citizens Advice Bureau Liverpool
  • Tirril Harris
    King's College London
  • Vashti Berry
    University of Exeter Medical School
  • Paula Byrne
    University of Liverpool
  • Elliot Carter
    Plymouth University
  • Pam Clarke
    University of Liverpool
  • Laura Cocking
    Plymouth University
  • Suzanne Edwards
    Swansea University
  • Richard Emsley
    University of Manchester
  • Mauro Fornasiero
    Plymouth University
  • Lucy Frith
    University of Liverpool
  • Shaun Harris
    Swansea University
  • Peter Huxley
  • Siw Jones
    Citizens Advice Bureau Liverpool
  • Peter Kinderman
    University of Liverpool
  • Michael King
    University College London
  • Liv Kosnes
    Swansea University
  • Daniel Marshall
    Plymouth University
  • Dave Mercer
    University of Liverpool
  • Carl May
    University of Southampton
  • Debbie Nolan
    Citizens Advice Bureau Liverpool
  • Ceri Philips
    Swansea University
  • Tim Rawcliffe
    Lancashire Care Foundation NHS Trust, Preston
  • Alexandra V. Sardani
    Swansea University
  • Elizabeth Shaw
    Plymouth University
  • Sam Thompson
    University of Liverpool
  • Jane Vickery
    Plymouth University
  • Brian Wainman
    Plymouth University
  • Mark Warner
    Plymouth University
Background
Depression and debt are common in the UK. Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer) aimed to assess the clinical effectiveness and cost-effectiveness of the addition of a primary care debt counselling advice service to usual care for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research.
Objectives
The overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. The specific objectives were to confirm methods for practice recruitment and the ability to recruit patients via the proposed approaches; to determine the acceptability of the study interventions and outcome measures; to assess contamination; to confirm the randomisation method for main trial and the level of participant attrition; and to check the robustness of data collection systems.
Design
An adaptive, parallel, two-group multicentre randomised controlled pilot trial with a nested mixed-methods process and economic evaluation. Both individual- and cluster (general practice)-level were was used in the pilot phase to assign participants to intervention or control groups.
Setting
General practices in England and Wales.
Participants
Individuals were included who were aged ≥ 18 years, scored ≥ 14 on the Beck Depression Inventory II and self-identified as having debt worries. The main exclusion criteria were being actively suicidal or psychotic and/or severely depressed and unresponsive to treatment; having a severe addiction to alcohol/illicit drugs; being unable/unwilling to give written informed consent; currently participating in other research including follow-up phases; having received Citizens Advice Bureau (CAB) debt advice in the past year; and not wanting debt advice via a general practice.
Interventions
The participants in the intervention group were given debt advice provided by the CAB and shared biopsychosocial assessment, in addition to treatment as usual (TAU) and two debt advice leaflets. The participants in the control group were given advice leaflets provided by the general practitioner and TAU only.
Main outcome measures
(1) Outcomes of the pilot trial – the proportion of eligible patients who consented, the number of participants recruited compared with target, assessment of contamination, and assessment of patient satisfaction with intervention and outcome measures. (2) Participant outcomes – primary – Beck Depression Inventory II; secondary – psychological well-being, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties, and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and at 4 months post randomisation. Other data sources – qualitative interviews were conducted with participants, clinicians and CAB advisors.
Results
Of the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 in the intervention group and 29 in the control group). All participants provided baseline outcomes and 52 provided the primary outcome at 4 months’ follow-up (14.7% dropout). Seventeen participants allocated to the intervention saw a CAB advisor. Descriptive statistics are reported for participants with complete outcomes at baseline and 4 months’ follow-up. Our qualitative findings suggest that the relationship between debt and depression is complex, and the impact of each on the other is compounded by other psychological, social and contextual influences.
Conclusions
As a result of low recruitment, this trial was terminated at the internal pilot phase and was too small for inferential statistical analysis. We recommend ways to reduce this risk when conducting complex trials among vulnerable populations recruited in community settings. These cover trial design, the design and delivery of interventions, recruitment strategies and support for sites.
Original languageEnglish
Number of pages197
JournalHealth Technology Assessment
Volume21
Issue number3
DOIs
Publication statusPublished - Jun 2017

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