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A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial)

A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial)

Authors :
Shireen Patel
Clement Boutry
Priya Patel
Michael P. Craven
Boliang Guo
Azhar Zafar
Joe Kai
David Smart
Debbie Butler
Fred Higton
Rebecca McNaughton
Paul M. Briley
Chris Griffiths
Neil Nixon
Kapil Sayal
Richard Morriss
Source :
Trials, Vol 23, Iss 1, Pp 1-14 (2022)
Publication Year :
2022
Publisher :
BMC, 2022.

Abstract

Abstract Background Major depression is the second leading cause of years lost to disability worldwide and is a leading contributor to suicide. However, first-line antidepressants are only fully effective for 33%, and only 40% of those offered psychological treatment attend for two sessions or more. Views gained from patients and primary care professionals are that greater treatment uptake might be achieved if people with depression could be offered alternative and more accessible treatment options. Although there is evidence that the Alpha-Stim Anxiety Insomnia and Depression (AID) device is safe and effective for anxiety and depression symptoms in people with anxiety disorders, there is much less evidence of efficacy in major depression without anxiety. This study investigates the effectiveness of the Alpha-Stim AID device, a cranial electrotherapy stimulation (CES) treatment that people can safely use independently at home. The device provides CES which has been shown to increase alpha oscillatory brain activity, associated with relaxation. Methods The aim of this study is to investigate the clinical and cost-effectiveness of Alpha-Stim AID in treatment-seeking patients (aged 16 years upwards) with moderate to moderately severe depressive symptoms in primary care. The study is a multi-centre parallel-group, double-blind, non-commercial, randomised controlled superiority trial. The primary objective of the study is to examine the clinical efficacy of active daily use of 8 weeks of Alpha-Stim AID versus sham Alpha-Stim AID on depression symptoms at 16 weeks (8 weeks after the end of treatment) in people with moderate severity depression. The primary outcome is the 17-item Hamilton Depression Rating Scale at 16 weeks. All trial and treatment procedures are carried out remotely using videoconferencing, telephone and postal delivery considering the COVID-19 pandemic restrictions. Discussion This study is investigating whether participants using the Alpha-Stim AID device display a reduction in depressive symptoms that can be maintained over 8 weeks post-treatment. The findings will help to determine whether Alpha-Stim AID should be recommended, including being made available in the NHS for patients with depressive symptoms. Trial registration ISRTCN ISRCTN11853110 . Registered on 14 August 2020

Details

Language :
English
ISSN :
17456215
Volume :
23
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
edsdoj.8cfb46f6fd7c4afba1cff703cb2fc721
Document Type :
article
Full Text :
https://doi.org/10.1186/s13063-022-06192-1