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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).
Patel, Shireen; Boutry, Clement; Patel, Priya; Craven, Michael P; Guo, Boliang; Zafar, Azhar; Kai, Joe; Smart, David; Butler, Debbie; Higton, Fred; McNaughton, Rebecca; Briley, Paul M; Griffiths, Chris; Nixon, Neil; Sayal, Kapil; Morriss, Richard.
  • Patel S; Institute of Mental Health, University of Nottingham, Nottingham, UK. shireen.patel@nottingham.ac.uk.
  • Boutry C; NIHR Applied Research Collaboration East Midlands, Leicester, UK. shireen.patel@nottingham.ac.uk.
  • Patel P; Institute of Mental Health, University of Nottingham, Nottingham, UK.
  • Craven MP; NIHR Applied Research Collaboration East Midlands, Leicester, UK.
  • Guo B; Institute of Mental Health, University of Nottingham, Nottingham, UK.
  • Zafar A; NIHR Applied Research Collaboration East Midlands, Leicester, UK.
  • Kai J; Institute of Mental Health, University of Nottingham, Nottingham, UK.
  • Smart D; NIHR Nottingham Biomedical Research Centre, Nottingham, UK.
  • Butler D; NIHR MindTech MedTech Co-operative, Nottingham, UK.
  • Higton F; Institute of Mental Health, University of Nottingham, Nottingham, UK.
  • McNaughton R; NIHR Applied Research Collaboration East Midlands, Leicester, UK.
  • Briley PM; General Practice Alliance (GPA) Federation Northants, Northampton, UK.
  • Griffiths C; Leicester Diabetes Centre University of Leicester, Leicester, UK.
  • Nixon N; Centre for Academic Primary Care, School of Medicine, University of Nottingham, Nottingham, UK.
  • Sayal K; NIHR School for Primary Care Research, University of Nottingham, Nottingham, UK.
  • Morriss R; General Practice Alliance (GPA) Federation Northants, Northampton, UK.
Trials ; 23(1): 250, 2022 Apr 04.
Article in English | MEDLINE | ID: covidwho-1775330
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Electric Stimulation Therapy / Depressive Disorder, Major / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adolescent / Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06192-1

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Electric Stimulation Therapy / Depressive Disorder, Major / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adolescent / Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06192-1