Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)

• DOI: 10.3310/hta21350
• Publication Date: 2017-06-26T08:33:38Z
• Authors: Mark B Gabbay; Adele Ring; Richard Byng; Pippa Anderson; Rod S Taylor; Caryn Matthews; Tirril Harris; Vashti Berry; Paula Byrne; Elliot Carter; Pam Clarke; Laura Cocking; Suzanne Edwards; Richard Emsley; Mauro Fornasiero; Lucy Frith; Shaun Harris; Peter Huxley; Siw Jones; Peter Kinderman; Michael King; Liv Kosnes; Daniel Marshall; Dave Mercer; Carl May; Debbie Nolan; Ceri Phillips; Tim Rawcliffe; Alexandra V Sardani; Elizabeth Shaw; Sam Thompson; Jane Vickery; Brian Wainman; Mark Warner
• Keywords: Adult; Counseling; Male; Social Work; Substance-Related Disorders; Cost-Benefit Analysis; 610; Pilot Projects; citizens advice; State Medicine; Young Adult; 03 medical and health sciences; 0302 clinical medicine; Medical technology; Humans; R855-855.5; debt; Aged; Depressive Disorder; Primary Health Care; Patient Selection; Health Services; Middle Aged; Patient Acceptance of Health Care; 16. Peace & justice; United Kingdom; 3. Good health; counselling; Mental Health; Patient Satisfaction; pilot randomised controlled trial; depression; Quality of Life; Female

Background Depression and debt are common in the UK. Debt Counselling for Primary Care: an adaptive randomised controlled pilot trial (DeCoDer) aimed to assess clinical effectiveness cost-effectiveness of addition a primary care counselling advice service usual patients with depression debt. However, study was terminated early during internal phase because recruitment delays. This report describes rationale, methods findings study, implications future research. Objectives The overarching aim identify resolve problems, thereby assessing feasibility main trial. specific objectives were confirm practice ability recruit via proposed approaches; determine acceptability interventions outcome measures; contamination; randomisation method level participant attrition; check robustness data collection systems. Design An adaptive, parallel, two-group multicentre nested mixed-methods process economic evaluation. Both individual- cluster (general practice)-level used assign participants intervention or control groups. Setting General practices England Wales. Participants Individuals included who aged ≥ 18 years, scored 14 on Beck Inventory II self-identified as having worries. exclusion criteria being actively suicidal psychotic and/or severely depressed unresponsive treatment; severe addiction alcohol/illicit drugs; unable/unwilling give written informed consent; currently participating other research including follow-up phases; received Citizens Advice Bureau (CAB) past year; not wanting general practice. Interventions group given provided by CAB shared biopsychosocial assessment, treatment (TAU) two leaflets. leaflets practitioner TAU only. Main measures (1) Outcomes – proportion eligible consented, number recruited compared target, assessment contamination, patient satisfaction measures. (2) Participant outcomes II; secondary psychological well-being, health social utilisation, satisfaction, substance misuse, record priority/non-priority debts, life events difficulties, explanatory assessed at baseline (pre-randomisation) 4 months post randomisation. Other sources qualitative interviews conducted participants, clinicians advisors. Results Of 238 expressions interest screened, 61 (26%) (32 29 group). All 52 months’ (14.7% dropout). Seventeen allocated saw advisor. Descriptive statistics reported complete follow-up. Our suggest that relationship between is complex, impact each compounded psychological, contextual influences. Conclusions As result low recruitment, this too small inferential statistical analysis. We recommend ways reduce risk when conducting complex trials among vulnerable populations community settings. These cover design, design delivery interventions, strategies support sites. Trial registration Current Controlled Trials ISRCTN79705874. Funding project funded National Institute Health Research (NIHR) Technology Assessment programme will be published full ; Vol. 21, No. 35. See NIHR Journals Library website further information. Mark Gabbay Adele Ring part-funded Collaborations Leadership Applied Care (CLAHRC) North West Coast Richard Byng Rod S Taylor, Vashti Berry Elizabeth Shaw CLAHRC South Peninsula.