REviewing long term anti-Depressant Use by Careful monitoring in Everyday practice (REDUCE) programme

Aim: To identify feasible, safe, effective, and cost-effective ways of helping patients taking long-term antidepressants withdraw from treatment when appropriate. Objectives: Conduct a systematic review of interventions used to help patients successfully withdraw from antidepressant treatment. Identify factors promoting or inhibiting treatment withdrawal, through interviews with patients, and focus groups with practitioners. Develop an internet-supported CBT-based intervention to support treatment withdrawal, through co-design and co-production with practitioners and patients. Determine the effectiveness of the intervention through a randomised controlled trial, and estimate cost-effectiveness from a health/social service perspective. Build a translational framework addressing how the intervention should be delivered, including overcoming practitioner and patient related barriers, to facilitate implementation. Background: Antidepressant prescriptions have risen steadily, due to GPs prescribing longer courses, and the average length of treatment is now >2yrs. Some people need long-term antidepressants to prevent relapse, but surveys suggest 30-50% have no indication for long-term use. However stopping is not easy, due to withdrawal symptoms including anxiety and mood changes which feel similar to the reason why treatment was started in the first place. Patients on long-term treatment are often given repeat prescriptions and reviewed only infrequently. When GPs are prompted to review patients and advise withdrawal where appropriate, only 7% successfully withdraw. Practitioners need guidance to provide support for withdrawal, and patients need 24hr support. Research plan: WS1. Systematic review of interventions facilitating antidepressant withdrawal (months 1-9). Papers will be identified through comprehensive searches (Medline/Embase/DARE/CINAHL/PsycINFO). Selection for inclusion, based on a priori criteria, will be by two independent researchers. A thematic synthesis will be performed, and if appropriate data will be combined through meta-analysis. WS2. Intervention planning (months 1-12). This will draw on our PPI and team's expertise, informed by theoretical modelling based on identified literature, and insights gained from CBT-based internet programmes for anxiety and depression. Planning will also be informed by 15-20 qualitative patient interviews, and focus groups with 15-20 practitioners. Thematic analysis will be used, checking agreement between analysts, and discussing emerging themes with the whole team. WS3. Co-production of internet-supported withdrawal intervention (months 10-24). Internet-supported advice for patients on dealing with withdrawal symptoms and when to seek help will be delivered using LifeGuide software developed in Southampton. Clinical support will be provided by a primary care mental health worker (PCMHW) by telephone. Other interventions identified in WS1-2, e.g. buddying, may be added. The website will be iteratively developed, through qualitative interviews with 15-20 patients, and 15-20 practitioners. Once a prototype is created, qualitative research with another 15-20 patients will explore whether it is acceptable, interesting, persuasive, and feasible. Think-aloud interviews will be employed, and thematic analysis used to identify improvements, iteratively. WS4. Feasibility RCT, to assess acceptability, recruitment, and outcome measures (months 22-36). We will recruit 20 patients per arm, from 14 practices over 3 months, and follow them up for 6 months. We will assess recruitment; attrition; choice of outcome questionnaires; and adherence (automatically recorded by LifeGuide). We will explore burden of treatment, need for mental health worker telephone support, and technical support. A qualitative process evaluation will be conducted through interviewing 15-20 patients and 15-20 practitioners. WS5. Fully powered RCT to demonstrate effectiveness, and cost-effecti