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 (Alpha-Stim-D Trial).

Why the research is needed

Major depression is the second leading cause of years lost to disability worldwide and is a leading contributor to suicide. According to the Office for National Statistics (ONS) since the beginning of the coronavirus pandemic the rates of depression in the community have more than doubled in Great Britain. Currently the two main forms of treatment offered for depression by the National Health Service (NHS) in United Kingdom (UK) are antidepressant medications and psychological treatments. However, antidepressants are only effective for 33% and are associated with a range of side-effects. Psychological treatments are as effective as antidepressants, however, only 40% of those offered psychological treatments attend for 2 sessions or more. Views gained from patients and primary care professionals are that greater treatment uptake might be achieved if people with depression are offered alternative and more accessible treatment options.

The Alpha-Stim AID device 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 to more relaxing alpha rhythms. It is safe and has few side effects. It is licensed to be sold directly to the public at a cost of approximately £500.

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 the National Institute of Health Research (NIHR), ARC East Midlands.

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 are doing 

We aim to 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 difficult to tell if it is the active device or not.  Participants will be asked to use the device 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.

Trial update

The trial has now successfully recruited 154 participants, which is a fantastic achievement given that all recruitment has been during the pandemic.

GP surgeries in the following regions are recruiting participants to the trial:

Nottinghamshire, Lincolnshire, Derbyshire, Leicestershire, Northamptonshire, Oxfordshire, Milton Keynes, Berkshire, Buckinghamshire

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.

Next Steps

We are continuing to recruit and getting more sites on-board! If you would like to be involved, please do get in touch.

Contact our Research Team at This email address is being protected from spambots. You need JavaScript enabled to view it.