Evidence map›Paper›PMID 35379314›Full record

Trial reportTrials2022

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).

Shireen Patel, Clement Boutry, Priya Patel, Michael P Craven, Boliang Guo, Azhar Zafar, Joe Kai, David Smart, Debbie Butler, Fred Higton and 6 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 1 country.

Shireen PatelInstitute of Mental Health, University of Nottingham, Nottingham, UK. shireen.patel@nottingham.ac.uk.ORCID http://orcid.org/0000-0002-5537-0717
Clement BoutryInstitute of Mental Health, University of Nottingham, Nottingham, UK.
Priya PatelInstitute of Mental Health, University of Nottingham, Nottingham, UK.
Michael P CravenInstitute of Mental Health, University of Nottingham, Nottingham, UK.
Boliang GuoInstitute of Mental Health, University of Nottingham, Nottingham, UK.
Azhar ZafarGeneral Practice Alliance (GPA) Federation Northants, Northampton, UK.
Joe KaiCentre for Academic Primary Care, School of Medicine, University of Nottingham, Nottingham, UK.
David SmartGeneral Practice Alliance (GPA) Federation Northants, Northampton, UK.
Debbie ButlerInstitute of Mental Health, University of Nottingham, Nottingham, UK.
Fred HigtonInstitute of Mental Health, University of Nottingham, Nottingham, UK.
Rebecca McNaughtonInstitute of Mental Health, University of Nottingham, Nottingham, UK.
Paul M BrileyInstitute of Mental Health, University of Nottingham, Nottingham, UK.
Chris GriffithsNorthamptonshire Healthcare NHS Foundation Trust, Kettering, UK.
Neil NixonNottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK.
Kapil SayalInstitute of Mental Health, University of Nottingham, Nottingham, UK.
Richard MorrissInstitute of Mental Health, University of Nottingham, Nottingham, UK.
University of Nottingham · GBNorthamptonshire Healthcare NHS Foundation Trust · GBNottinghamshire Healthcare NHS Foundation Trust · GBUniversity of Leicester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMajor 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.

methodsThe 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 registrationISRTCN ISRCTN11853110 . Registered on 14 August 2020.

Indexed as

COVID-19Electric Stimulation TherapyMajor Depressive DisorderAdolescentCost-Benefit AnalysisDepressionHumansPandemicsPrimary Health CareAlpha-Stim AIDAntidepressantsCranial electrotherapy stimulationDepressionPrimary careRandomised controlled trial

Identifiers

PMID35379314
PMCPMC8978160
OpenAlexW4226018281

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.