Development of a guideline for use in the identification and categorization of adverse events in trials of digital and online psychological interventions: An umbrella review
What is the AVERT project?
The AVERT project is led by researchers from the University of Nottingham and is funded by the NIHR Applied Research Collaboration East Midlands (ARC-EM). The project considers how adverse events, such as unwanted effects or potential harms that might happen when testing an online or digital intervention, can be best identified, monitored, and reported in mental health interventions.
Why the research is needed?
Trials usually aim to test whether interventions can positively impact people’s mental health, but we must look at the positive and negative effects of any interventions. Clinical trials in mental health research currently use guidelines developed for adverse events in drug trials, but the adverse events from drugs can be very different from what might happen in a mental health trial. Researchers have already looked at adverse events for various mental health conditions using systematic reviews, which bring together all the available information on adverse events in a standard way. There is limited research looking specifically at adverse events for digital interventions for mental health and that is why we are doing this research.
What we will do?
First, we will conduct a systematic review of all the existing reviews relating to adverse event reporting in mental health trials. We will find and consider the published reviews, focusing on adverse events in trials of mental health interventions. We will look at how adverse events have been identified, monitored, and reported in these trials and summarise the main findings, as well as consider the findings relevant to digital mental health interventions.
We will then hold an online workshop to further discuss how adverse events can be best identified, monitored, and reported in digital mental health interventions. The workshop will be recorded and transcribed. At the workshop, we will discuss and agree on the important factors relating to adverse events in digital mental health interventions. We will bring together all the findings to develop recommendations which identify ways to consider adverse events in digital mental health intervention research and highlight gaps in the existing knowledge.
Who we are working with?
The workshop will include people who have experience researching or using digital technology, experience with mental health challenges, and/or knowledge of adverse events in psychological trials. All group members will be experts based on their lived experience or contributions to mental health, digital technology, guideline development, or adverse events.
How patients and the public are involved?
The project will involve co-production and will involve up to 6 people who have lived experience of mental health. This experience may be either through direct experience or as a parent/carer of a person with a mental health difficulty or condition, or experience as a participant in a mental health trial, or experience in using digital technology to help support mental health. We will also have support from the MindTech Involvement Team at the University of Nottingham.
What the benefits will be?
The recommendations will be the first step in thinking about adverse events in digital mental health trials. They may be relevant to researchers planning digital mental health interventions and healthcare professionals looking at and using the research in their work. If researchers use the recommendations, we hope that they may also help the people taking part in trials have a better experience during the trial.
When the findings will be available?
The findings will be available in 2024.
How we are planning for implementation?
After the paper is written the recommendations made will need to be further assessed by researchers using them. The information will be freely available online as well as published in a peer-reviewed research publication. Seeking follow-on funding, we will ask researchers to inform us of how the guidance and recommendations have helped and any amendments they think are needed. We will also look at when the research has been cited in published scientific papers.