About the study
Background
This research will improve Australian health outcomes by decreasing unnecessary and potentially harmful long-term (>12 months) use of antidepressants. The outcomes of our research will include a validated antidepressant discontinuation model and proven implementation strategies including practical resources where currently there are none to foster sustainable improvement in primary mental health care.
Australia has one of the highest rates of antidepressant use in the world with around 1 in 7 Australian adults currently taking antidepressants, many of them long-term. Yet clinical guidelines usually recommend only 6 to 12 months therapy for a single episode of major depression and non-pharmaceutical therapy as first line for anxiety and less severe depression. In Australia, most antidepressants are prescribed in general practice (86%).
Long-term antidepressant use is not harmless. But people often struggle to stop antidepressants because they experience unpleasant withdrawal symptoms which are commonly misconstrued as impending 'relapse' or ongoing need for medication.
Aim
The RELEASE study will evaluate effectiveness of the RELEASE and RELEASE+ interventions compared to Usual care. The RELEASE multi-strategy intervention has been designed to prompt medication review, support shared decision-making and guide safe cessation of antidepressants when there is no clinical indication for continued use.
Design
This is a 3-arm cluster randomised controlled effectiveness-implementation trial in 28 general practices in south-east Queensland.
Principles
RELEASE is a user-informed multi-modal intervention that targets both general practitioners and patients. RELEASE has the following guiding principles:
- All prescribing decisions are made as usual by the GP and patient together.
- Empowering patients.
- Acceptable and translatable in routine general practice.
- Resources developed to raise awareness, prompt medication review, support shared decision-making, and guide safe cessation of long-term antidepressants when there is no clinical indication for continued use.
Vision
RELEASE seeks to improve Australian health outcomes by decreasing unnecessary and potentially harmful long-term (>12 months) antidepressant use.
Who is conducting this research
The RELEASE research leads are Professor Katharine Wallis and Associate Professor Maria Donald in the General Practice Clinical Unit at The University of Queensland.
Recruiting general practices
We are currently recruiting general practices in southeast Queensland. Please contact us if your practice and GPs would like to participate in the study. Patients are only recruited into the study through participating practices.
Contact
Email: release.study@uq.edu.au
Timeline
Recruitment of general practices from December 2022.
Who is funding this research
Medical Research Future Fund (MRFF) 2020 Clinician Researchers: Applied Research in Health - MRFAR000079 (Commonwealth Department of Health)
National Health and Medical Research Council (NHMRC) 2021 Partnership Projects PRC3 – 2015744
Ethical Conduct
This study adheres to the Guidelines of the ethical review process of The University of Queensland and the National Statement on Ethical Conduct in Human Research.
The University of Queensland Human Research Ethics Committee approval number: 2022/HE001667.
Whilst you are free to direct questions you may have to our Project Coordinator and Patient Liaison Officer via release.study@uq.edu.au, if you would like to speak to an officer of the University not involved in the study, you may contact the Ethics Coordinators on +617 3365 3924 / +617 3443 1656 or email humanethics@research.uq.edu.au.
Related Research
- Exploring long-term antidepressant use in general practice
- Optimising RELEASE resources for patients
- Safer Prescribing And Care for the Elderly (SPACE): Cluster RCT in New Zealand General Practice
- Antidepressant prescribing in general practice: A call to action
- Springer Nature: RELEASE Article
RELEASE Research Team
Research Leads
Research Team
Collaborating Investigator/s
Dr Mark Horowitz (Psychiatrist)
Clinical Research Fellow, North East London NHS Foundation Trust; and Honorary Clinical Research Fellow,
University College London, UK
Professor Joanna Moncrieff (Psychiatrist)
Professor of Critical and Social Psychiatry, University College London, UK; and Honorary Consultant Psychiatrist,
North East London Foundation NHS Foundation Trust
Professor Rob Ware (Senior Biostatistician)
Menzies Health Institute, Griffith University, Australia
Professor Joshua Byrnes (Senior Health Economist)
Director, Centre for Applied Health Economic, Griffith University, Australia
