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The purpose

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, United Kingdom. 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 social functioning. 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 suspected GAD.

Provided treatments

  • Device: Alpha Stim AID cranial electrotherapy stimulation
  • Behavioral: Pregnancy test
  • Other: Anxiety questionnaire
  • Other: Quality of life questionnaire
  • Other: Work and social questionnaire
  • Other: Sleep questionnaire
  • Other: Depression questionnaire
  • Other: Quality of life and financial questionnaire

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02901080. The sponsor of the trial is Electromedical Products International, Inc. and it is looking for 161 volunteers for the current phase.
Official trial title:
Naturalistic Study of Alpha-Stim in Patients With a Primary Working Diagnosis of Moderate-to-severe Generalised Anxiety Disorder Who Did Not Improve With Low Intensity Psychological Therapy Intervention