David Ekers

Background Depression is common in people with long-term health conditions, and this combination can lead to worsened health outcomes and increased health-care costs. Subthreshold depression, a risk factor for major depression, is prevalent in this population, but many people remain untreated due to the demand on services. The community pharmacy may be an alternative setting to offer mental health support; however, insufficient evidence exists to support implementation. Objectives To conduct a feasibility study and pilot randomised controlled trial of a community pharmacy-delivered psychological intervention aimed at preventing depression in adults with long-term health conditions. Design A feasibility study with nested qualitative evaluation and an external pilot, two-arm, 1 : 1 individually randomised controlled trial with nested process and economic evaluations. Setting Community pharmacies in the north of England. Participants Adults aged ≥ 18 years with subthreshold depression and at least one long-term health condition. Intervention A bespoke enhanced support intervention (behavioural activation within a collaborative care framework) involving up to six sessions delivered by trained community pharmacy staff (intervention facilitators) compared with usual care. Main outcome measures Recruitment and retention rates, completeness of outcome measures and intervention engagement. The intended primary outcome was depression severity at 4 months, assessed by the Patient Health Questionnaire-9. Results In the feasibility study, 24 participants were recruited. Outcome measure completeness was 95–100%. Retention at 4 months was 83%. Seventeen participants (71%) commenced intervention sessions and all completed two or more sessions. Depression symptoms reduced slightly at 4 months. The process evaluation suggested that the intervention was acceptable to participants and intervention facilitators. In the pilot randomised controlled trial, 44 participants (target of 100 participants) were randomised (intervention, n = 24; usual care, n = 20). Outcome measure completeness was 100%. Retention at 4 months was 93%. Eighteen participants (75%) commenced intervention sessions and 16 completed two or more sessions. Depression symptoms reduced slightly at 4 months, with a slightly larger reduction in the usual-care arm, although the small sample size limits any conclusions. The process evaluation reported good acceptability of the intervention and identified barriers associated with study implementation and its impact on core pharmacy functions. The economic analysis revealed some indication of reduced resource use/costs associated with the intervention, but this is limited by the small sample size. Intervention costs were low.