Community pharmacies mood intervention study (CHEMIST)

INTERVENTION: Feasibility study: All participants receive the Enhanced Pharmacy Support Intervention (ESI). The ESI will be adapted for use with individuals with sub‐threshold depression and long‐term conditions, and will consist of four elements: Behavioural Activation focused self‐help support; Proactive follow‐up; Symptom monitoring; and Decision supported signposting. It will be delivered by suitably trained pharmacy support staff experienced in delivery of extended pharmacy roles (such as smoking cessation behavioural change approaches) over 4‐6 sessions in a 4 month period either over the phone or face‐to‐face in the privacy of pharmacy consulting rooms. Participants are followed up at 4 months post‐recrutiment. Pilot RCT: Participants are randomised in a 1:1 ratio using the independent online randomisation service provided by the York Trials Unit) to one of two group. Intervention group: Participants receive the Enhanced Pharmacy Support Intervention (ESI) over 4‐6 sessions in a 4 month period either over the phone or face‐to‐face in the privacy of pharmacy consulting rooms, as in the feasigbility study. Control group: Participants receive usual primary care management of sub‐threshold depression offered by the GP or other local community provision. Participants in both groups are followed up at 4 months post‐randomisation. CONDITION: Specialty: Public health, Primary sub‐specialty: Public health; UKCRC code/ Disease: Mental Health/ Mood [affective] disorders ; Mental and Behavioural Disorders ; Depression PRIMARY OUTCOME: Feasibility Study:; 1. Recruitment and attrition rates; 2. Quality of data collection at baseline and 4 months ; 3. ESI adherence; 4. Process evaluation is undertaken through qualitative interviews with participants, ESI facilitators and pharmacy staff; ; Pilot RCT:; Self‐reported depression severity is measured by the Patient Health Questionnaire (PHQ9) at baseline and 4 months. SECONDARY OUTCOME: Pilot RCT:; 1. Prevention of depression measured by binary depression scores on the PHQ9 at baseline and 4 months; 2. Anxiety is measured using the GAD7 at baseline and 4 months; 3. Health Related Quality of Life measured by the SF‐12v2 at baseline and 4 months; 4. Health State Utility measured by the EQ‐5D at baseline and 4 months; 5. Health Service Use, collected by a bespoke questionnaire (adapted AD‐SUS) at baseline and 4 months; 6. Participant’s use of Enhanced Support Intervention, collected from intervention facilitator records at 4 months; 7. Process evaluation is undertaken using qualitative interviews with participants, pharmacy staff and GPs at 4 months INCLUSION CRITERIA: 1. Adults (male or female, aged 18 years and over) 2. One or more long‐term conditions (Arthritis, Cancer, Cardiovascular Conditions, Diabetes, Respiratory Conditions, Stroke). 3. Sub‐threshold depression (screen positive with 2‐4 symptoms confirmed by diagnostic assessment tool)