Randomised controlled trial of the clinical and cost effectiveness of Alpha-Stim cranial electrotherapy stimulation in treatment seeking patients with moderate severity or persistent mild depressive episodes in primary care
Why the research is needed?
Depression affects one person in every six in a year. Many people with depression do not find anti-depressant medication or talking therapies to be helpful, acceptable or easy to access so they do not seek help with their depression. Alpha-Stim AID is a clinically proven battery operated medical device that provides cranial electrotherapy stimulations (CES) to treat anxiety, insomnia and depression. The device changes the electrical activity of the brain from more stressful delta and beta rhythms to more relaxing alpha rhythms.
What is already known about the subject?
Research shows Alpha-Stim AID improves anxiety and depression symptoms in people with anxiety disorders. It is safe and has few side effects. It is licensed to be sold directly to the public at a cost of approximately £500.
Who we are working with?
We are working with people with depression, GPs, nurses, mental health specialists, technical experts and companies in the East Midlands and nationally. The device is manufactured by a company called Electromedical Products International, and is distributed in the UK by a company called The Microcurrent Site Limited.
How are patients and the public involved?
Our PPIE representatives have expressed the need for different treatments for depression such as Alpha-Stim AID. This treatment is convenient because it can be used at home whilst resting or doing light activity. In developing this study, we have consulted with a number of PPIE representatives and the intervention has been co-designed through PPIE input. Involving people with lived experience of Depression is vital to develop an intervention that people will want to use. Our PPIE representatives will comment on the study at all stages and help us to ensure that our study is presented in lay-friendly format.
What we will do?
We will ask 230 people with depression attending their GP surgery who have moderate depression to take part. By a process like tossing a coin, people with depression will either be allocated to use an active Alpha-Stim AID device or a device that looks exactly the same but does not emit a current. The current is so small it is impossible to tell if it is the active device or not. Participants will be asked to use the devices every day for one hour for eight weeks. We will measure any change in depressive and anxiety symptoms and change in healthcare service use 2 months after using the device. We will also ask people their thoughts on using the device.
What the benefits will be?
The study will help to determine whether Alpha-Stim AID should be made available on the NHS for patients with depressive symptoms.
When the findings will be available?
The findings will be available in September 2022.
How we are planning for implementation?
We are working with companies, primary care, mental health services, NHS commissioners, the public and AHSN East Midlands. The company will ask NICE to support its use if the device works for depression and is good value for money.
Shireen Patel, firstname.lastname@example.org