Trial Name
REDUCE - REVIEWING LONG TERM ANTIDEPRESSANT USE BY CAREFUL MONITORING IN EVERYDAY PRACTICE
Description
There is considerable concern about increasing antidepressant use in England. GPs are writing more than 60 million prescriptions a year, to around 1-in-10 adults. Some people need long-term antidepressants to stop them getting depressed, but a third-to-a-half could possibly stop them without relapsing. Taking antidepressants long-term exposes patients to the risks of side-effects. People taking antidepressants report their GPs rarely review them and just give repeat prescriptions. Studies show that when GPs do review patients on long-term antidepressants and recommend that they could begin to stop taking them, only 1-in-14 is able to stop. Patients can be fearful and cessation can be tricky, so GPs and Nurse Practitioners (NPs) who prescribe antidepressants need to develop individual cessation strategies for each patient, and be able to offer them sustained support, especially in the first few weeks or months. The REDUCE research programme aims to identify feasible, safe, effective, and cost-effective ways of helping patients taking long-term antidepressants taper off and stop treatment, when appropriate.
Objectives
- Conduct a systematic review of interventions used to help patients successfully stop antidepressant treatment.
- Identify factors promoting or inhibiting treatment cessation, through interviews with patients, and focus groups with practitioners.
- Develop an internet-supported CBT-based intervention to support treatment tapering and cessation, 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.
Design
The REDUCE Programme consists of five work streams (WS):
- WS1. Systematic review of interventions facilitating antidepressant withdrawal.
- WS2. Intervention planning.
- WS3. Co-production of internet-supported withdrawal intervention.
- WS4. Feasibility randomised controlled trial to assess acceptability, recruitment, and outcome measures:
- 20 patients per arm (intervention and control), recruited from 14 practices over 3 months, and followed up for 6 months.
- Recruitment, attrition, choice of outcome questionnaires, and adherence will be assessed.
- Burden of treatment, need for mental health worker telephone support, and technical support assessed by interviewing 15-20 patients and 15-20 practitioners.
- WS5. Fully powered RCT to demonstrate effectiveness, and cost-effectiveness:
- Patients in both arms (intervention and control) will have treatment reviewed by their GP/NP, with appointments for follow-up.
- Intervention arm practitioners will be trained in supporting withdrawal, and patients helped to engage with the web-based support package.
- 402 patients recruited from 134 practices.
- Quantitative assessment of effects of baseline patient characteristics and psychological factors.
- Qualitative interviews to understand patients’ perspectives and influences on trial outcomes.
Population
Patients who are taking long-term antidepressant treatment, including:
- Patients on treatment for more than 1 year for a first episode,
- Patients treated for more than 2 years for a recurrent episode no longer depressed or judged to be at significant risk of relapse.
Potential participants will be approached in two ways:
- Through practice records database searches
- Opportunistically in general practitioner (GP) or nurse practitioner (NP) consultations
Contacts
Sponsor: University of Southampton
Chief Investigator: Professor Tony Kendrick
Programme Manager: Wendy O’Brien
Stufy Coordinator: Dr Hannah Bowers
Email: reduce@soton.ac.uk
REDUCE Website