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)
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....
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| Format: | Article |
| Language: | English |
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BMC
2022-04-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06192-1 |
| _version_ | 1811272636928360448 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Shireen Patel |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-04-12T22:43:56Z |
| format | Article |
| id | doaj.art-8cfb46f6fd7c4afba1cff703cb2fc721 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T22:43:56Z |
| publishDate | 2022-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-8cfb46f6fd7c4afba1cff703cb2fc7212022-12-22T03:13:38ZengBMCTrials1745-62152022-04-0123111410.1186/s13063-022-06192-1A 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 Patel0Clement Boutry1Priya Patel2Michael P. Craven3Boliang Guo4Azhar Zafar5Joe Kai6David Smart7Debbie Butler8Fred Higton9Rebecca McNaughton10Paul M. Briley11Chris Griffiths12Neil Nixon13Kapil Sayal14Richard Morriss15Institute of Mental Health, University of NottinghamInstitute of Mental Health, University of NottinghamInstitute of Mental Health, University of NottinghamInstitute of Mental Health, University of NottinghamInstitute of Mental Health, University of NottinghamGeneral Practice Alliance (GPA) Federation NorthantsCentre for Academic Primary Care, School of Medicine, University of NottinghamGeneral Practice Alliance (GPA) Federation NorthantsInstitute of Mental Health, University of NottinghamInstitute of Mental Health, University of NottinghamInstitute of Mental Health, University of NottinghamInstitute of Mental Health, University of NottinghamNorthamptonshire Healthcare NHS Foundation TrustNottinghamshire Healthcare NHS Foundation TrustInstitute of Mental Health, University of NottinghamInstitute of Mental Health, University of NottinghamAbstract 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 2020https://doi.org/10.1186/s13063-022-06192-1DepressionPrimary careAlpha-Stim AIDCranial electrotherapy stimulationAntidepressantsRandomised controlled trial |
| spellingShingle | 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 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) Trials Depression Primary care Alpha-Stim AID Cranial electrotherapy stimulation Antidepressants Randomised controlled trial |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Depression Primary care Alpha-Stim AID Cranial electrotherapy stimulation Antidepressants Randomised controlled trial |
| url | https://doi.org/10.1186/s13063-022-06192-1 |
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