What is the study about?

The primary objective of the study is to explore the clinical efficacy of active Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) versus sham Alpha-Stim AID CES on depression symptoms at 16 weeks (8 weeks after the end of treatment) in people with moderate Depression. An economic evaluation alongside the clinical trial was conducted to assess whether the ACTIVE ALPHA-STIM-D intervention is cost effective compared to SHAM ALPHA-STIM.

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.

Who can take part in the study?

Participants with moderate depression

What is being tested in the study?

The study will help to determine whether Alpha-Stim AID should be made available on the NHS for patients with depressive symptoms.

Funder

National Institute for Health and Care Research - Applied Research Collaboration East Midlands (NIHR - ARC)

Useful links