Title: Community pHarmaciEs Mood Intervention STudy (CHEMIST). Feasibility and Pilot Study
Funder: Department of Health and Social Care

Abstract: FEASIBILITY STUDY DESIGN: A before and after observational/qualitative study. SETTING: UK community pharmacy settings (Durham/Teesside). POPULATION: People with long term health conditions who screen-positive for depression but who do not reach the threshold for DSM IV Moderate Depressive disorder. INTERVENTION: Enhanced Support Intervention (ESI) delivered by an appropriately trained community pharmacy team member of 4-6 follow up sessions over 4 months. ESI is a modified form of collaborative care for sub-threshold depression validated in previous studies in UK primary care which appears suitable for dissemination to community settings. Defining features are a brief psycho-social intervention (behavioural activation based on goal orientated activity scheduling) using facilitated self-help developed and tested in previous studies in comparable populations. Pre-existing training, intervention and self-help materials (developed by co applicants) will be adapted for use in community pharmacy in consultation with PPI and stakeholder groups. SAMPLE SIZE: 20-30 OUTCOMES: As we are assessing feasibility we will assess study implementation (recruitment and attrition rates), quality of data collection at baseline and 4 months and ESI adherence (number of contacts, DNA and drop out). QUALITATIVE EVALUATION: In depth interviews with up to 10 patients and 4 ESI facilitators and one focus group (range of pharmacy staff n=8-10) will be conducted to explore feasibility and acceptability of the training, intervention and study procedures. Findings will inform adaptations prior to pilot trial. PILOT STUDY DESIGN: Pilot randomised controlled trial, including a prospective economic and qualitative evaluation. SETTING As above incorporating North Yorkshire POPULATION: As Above INTERVENTION: As above with adaptations post feasibility study. COMPARATOR: Usual care SAMPLE SIZE: 100 participants. OUTCOMES: Data will be used to estimate recruitment, intervention delivery and study completion rates. We will not make definitive estimates of the effectiveness of ESI. PRIMARY OUTCOME: depression severity (Patient Health Questionnaire 9) at 4 months. SECONDARY OUTCOMES: Patient acceptance, uptake and attrition. We will also measure ICD10 depression status; anxiety at 4 months (GAD 7); health related quality of life (SF-12); health-state utility (EQ5D) at 4 months. ECONOMIC EVALUATION: The incremental cost per QALY will be calculated from both the NHS and societal perspective. PROCESS EVALUATION: Using mixed methods we will examine potential mediators/moderators of the intervention, the acceptability (to participants and pharmacy staff), barriers and facilitators to the use of ESI in community pharmacy, and impact on usual practice. Qualitative interviews with up to 20 patient participants, up to 10 pharmacy staff and up to 10 GPs will be used. HEALTH INEQUALITIES: We will prospectively sample pharmacies from a range of socio economic areas and explore potential benefit of the intervention though quantitative, economic and qualitative analysis. PROJECT TIMETABLES. Project set up/intervention refinement meetings (mnths -6-2). Feasibility study recruitment and intervention delivery (mnths 2-8), analysis/write up (mnths 9-12). Pilot study site set up (mnths 10-12), recruitment/intervention delivery (mnths 12- 19), follow up (mnths 20-24) and analysis/write up (mnths 24-28).

Lay abstract: About 30% of the UK population have long term physical health problems. In those that do, depression is 2-3 times more common than in the general population. Depression alongside long term physical health problems can worsen health outcomes, quality of life and double healthcare costs. People with these conditions are more likely to live in poorer areas, contributing significantly to health inequalities. For most people with milder depression their symptoms will go undetected/untreated alongside physical health problems. This is disappointing as treatments can help and improve quality of life. One treatment we recently tested in the UK in people over 65 with mild depression (most with long term health problems), called collaborative care, was acceptable and effective. It reduced depression symptoms at 4 and 12 months and nearly halved progression to major depression, compared to usual primary care. The intervention was delivered by people with no professional qualification, but who were trained/supported by experts in the approach. It included a psychological self-help treatment called behavioural activation supported by structured phone/face to face sessions, regular use of a mood measurement questionnaire and liaison with the person s GP if needed. As eight out of 10 people live within 20 minutes walk of a pharmacy we think they may provide an excellent public health setting for such an intervention, having a strong presence in poorer communities. Pharmacies are well placed to offer opportunistic psychological support to people with long term physical problems who attend their pharmacy for a range of health related services. In the CHEMIST study we aim to adapt our treatment and see if it can be delivered by suitably trained community pharmacy staff to adults with mild depression and long term health problems. If beneficial in this setting the intervention could reach many people who remain untreated. We plan to conduct two phases of research to test if a larger definitive study would be possible. In phase one we will train a small number of pharmacy staff to test our proposed study recruitment, intervention and data collection processes. We plan to recruit 20-30 people via pharmacies, community settings or local GP practices. By using interviews with participants and staff and observing recruitment, intervention acceptance and data completion rates we will refine our research approaches/intervention. In Phase two we will run a randomised controlled trial in miniature with 100 people testing our intervention against usual care . By observing how many people we need to approach, screen and asses to recruit this number and by observing how well we can treat people and collect those data we need, we will be able to decide if a larger study is possible. We will collect a range of questionnaires at the start and at 4 months. We will also conduct detailed interviews with 10 participants and a range of staff to get an in depth understanding of our procedures. If we are successful in meeting our aims we will seek separate funding to run a larger study to reliably answer the question does enhanced support in pharmacies work for less severe depression, can it prevent progression to major depression and does it represent value for money ? Local pharmacy networks, pharmacy user groups and local authorities will ensure a fit for purpose intervention is developed.

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