The Alpha-Stim-D trial has successfully recruited 236 participants meeting its target 25 days ahead of time despite recruitment being delayed by six months due to COVID-19 pandemic.
Professor Richard Morriss commented “The study recruited ahead of time despite 6 months delay from COVID-19. This shows how popular the device is with GPs and patients. There is clearly a need for alternative treatments for depression and anxiety in addition to antidepressants and psychological treatment. This is popular with patients because they can do it at home and it has very few side effects.”
Shireen Patel, the study’s Operational Lead Researcher, said: “This is a fantastic achievement given that all the recruitment has been during the pandemic. We are extremely grateful to primary care GP surgeries for referring patients to the study during these unprecedented and challenging times."
The Alpha-Stim-D Trial is a Randomised Controlled Trial (RCT) investigating the clinical and cost effectiveness of the Alpha-Stim AID device for the treatment of depressive symptoms in Primary Care. The trial is funded by ARC East Midlands. The study is led by Chief Investigator Professor Richard Morriss and has been supported by Primary Care CRNs in the East Midlands and Thames Valley and South Midlands (TVSM).
GP surgeries in the following regions have recruited participants to the trial:
- Nottinghamshire
- Lincolnshire
- Derbyshire
- Leicestershire
- Northamptonshire
- Oxfordshire
- Milton Keynes
- Berkshire
- Buckinghamshire.
The University of Nottingham Health Service was the top recruiting site for this study, assisted by their clinical research practitioners they have recruited 59 participants – 25% of the trial’s participants.
Mental Health Nurse Practitioner Stuart Keeling said: “I have seen the very clear benefits that Alpha-Stim has provided to patients who are experiencing mental health difficulties. It is very easy to use, and patients report that they have found it beneficial to use at a time which works for them and does not restrict their day-to-day plans. Alpha-Stim has very much complemented patients’ existing recovery approaches.”
Another research nurse at this site said: “This is the easiest study I’ve ever done; the research team are very communicative and always answer questions, including sending me a You Tube video that was very helpful. The instructions are clear and concise, and it’s been a pleasure working on this research study.”
A GP involved, who is based in an area of relative deprivation where research recruitment is challenging, said: “Referring patients to the Alpha Stim D study at the University of Nottingham has been very straightforward. We have found that patients with moderate depression have welcomed the idea that there is something they can try which does not involve trying yet more medication. The patients who have taken part in the study have been happy with the information and support from the researchers. We look forward to hearing about the results of this important study.”
Another GP from Lincolnshire said: “Participating in the Alpha-Stim-D trial has been extremely rewarding as it provides another option for patients suffering from significant disability from depression, who are already on medication and haven’t got the time or faith in another course of talking therapies. It’s proved extremely popular with patients, and we await the results with great interest.”
The trial has completed recruitment and is now in the follow up stage of the project. The next steps will be to complete collection of all outcome data and analysis of the data. Qualitative interviews will also be taking place with some participants who were involved in the trial.
Shireen added: “The Alpha-Stim-D trial team would like to say a huge thank you to everyone who has participated and supported the trial. Your contributions and ongoing support have been extremely valuable in helping us to reach our recruitment target. We hope to share the findings of the trial in due course.”
Published on: 8 Feb 2022