This is a single-centre research study in patients seen within an NHS Improving Access to
Psychological Interventions (IAPT) service with suspected generalised anxiety disorder (GAD).
The study will involve 120 patients from the Leicestershire and Rutland area in England,
Participants will use the Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) medical
device, which is approved for use and proven to be safe and work for the treatment for
anxiety, depression and insomnia.
Participants will use the Alpha-Stim AID for 60 minutes every day for 6 or 12 weeks, either
whilst on the waiting list for standard care treatment from IAPT, or in conjunction with
standard care treatment from IAPT.
The study will involve 6 study visits - one face-to-face at visit 1, followed by 5 visits via
telephone at week 4, 6, 8, 12 and 24. At each visit, participants will be asked to complete
questionnaires to assess anxiety, depression, sleep difficulty, quality of life and work and
The purpose of the study is to gather evidence for the clinical benefits and cost
effectiveness of the Alpha-Stim AID when used in an NHS setting - how well does it work, and
does it's use result in cost savings for the NHS.
The study may show that the Alpha-Stim AID should be available on the NHS for patients with