Background: Symptoms of anxiety disorders are highly common and can have a severe
impact on people’s lives; they are typically treated with psychotherapy and/or
anti-anxiety medication. These treatments are not suitable for, acceptable to,
or effective for everyone. Alpha-Stim AID is a cranial electrotherapy
stimulation (CES) device with evidence of effectiveness in treating symptoms of
anxiety. In this study, Alpha-Stim AID was offered through a United Kingdom
(UK) universal community healthcare provider, Intermediate Care Team (ICT) community healthcare
service to patients who reported signs of anxiety. Objective: The aim of
this paper is to present feasibility findings and outcomes on anxiety, health
status, and quality of life. Methods: Open-label patient cohort design,
with no control group. Participants were adults who reported symptoms of
anxiety and were under the care of universal national health service (NHS)
Intermediate Care Team (ICT) community healthcare service in the United Kingdom
(UK). Pre- and post-intervention assessment used participant self-report measures: generalised
anxiety disorder (GAD-7) and health related quality of life (EQ-5D-5L). The
three ICT staff members who offered the Alpha-Stim AID to patients completed a
questionnaire on their experience. Results: Eighteen patients used the
Alpha-Stim and completed outcome measures. GAD-7 scores significantly improved
from 13.9 (SD = 4.3) to 7.3 (SD = 5.7) (p < 0.001), with a large effect size of 0.88. Analysis of EQ-ED-5L health
index score conversions indicated perceived quality of life increased from 0.31
(SD = 0.25) to 0.48 (SD = 0.28) at end (p = 0.036), with a small effect size of 0.12. EQ-VAS scores at baseline improved
from 49.2 (SD = 24.0) to 64.4 (SD = 26.2) at the end
References
[1]
Anderson, H. D., Pace, W. D., Libby, A. M., West, D. R., & Valuck, R. J. (2012). Rates of 5 Common Antidepressant Side Effects among New Adult and Adolescent Cases of Depression: A Retrospective US Claims Study. Clinical Therapeutics, 34, 113-123. https://doi.org/10.1016/j.clinthera.2011.11.024
[2]
Bandelow, B., Michaelis, S., & Wedekind, D. (2017). Treatment of Anxiety Disorders. Dialogues in Clinical Neuroscience, 19, 93-107. https://doi.org/10.31887/DCNS.2017.19.2/bbandelow
[3]
Barclay, T. H., & Barclay, R. D. (2014). A Clinical Trial of Cranial Electrotherapy Stimulation for Anxiety and Comorbid Depression. Journal of Affective Disorders, 164, 171-177. https://doi.org/10.1016/j.jad.2014.04.029
[4]
Bespalov, A. Y., van Gaalen, M. M., & Gross, G. (2009). Antidepressant Treatment in Anxiety Disorders. In M. Stein, & T. Steckler (Eds.), Behavioral Neurobiology of Anxiety and Its Treatment. Current Topics in Behavioral Neurosciences, Vol. 2 (pp. 361-390). Springer. https://doi.org/10.1007/7854_2009_3
[5]
Brooks, R., & Group, E. (1996). EuroQol: The Current State of Play. Health Policy, 37, 53-72. https://doi.org/10.1016/0168-8510(96)00822-6
[6]
Clark, D. M., Canvin, L., Green, J., Layard, R., Pilling, S., & Janecka, M. (2018). Transparency about the Outcomes of Mental Health Services (IAPT Approach): An Analysis of Public Data. The Lancet, 391, 679-686. https://doi.org/10.1016/S0140-6736(17)32133-5
[7]
Davies, J., & Read, J. (2019). A Systematic Review into the Incidence, Severity, and Duration of Antidepressant Withdrawal Effects: Are Guidelines Evidence-Based? Addictive Behaviors, 97, 111-121. https://doi.org/10.1016/j.addbeh.2018.08.027
[8]
Department of Health (2006). Our Health, Our Care, Our Say: A New Direction for Community Services. The Stationery Office. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/272238/6737.pdf
[9]
Devlin, J. N., Shah, K. K., Feng, Y., Mulhern, B., & Hout, B. (2017). Valuing Health-Related Quality of Life: An EQ-5D-5L Value Set for England. Health Economics, 27, 7-22. https://doi.org/10.1002/hec.3564
[10]
Electromedical Products International Inc. (2022). https://www.alpha-stim.com/
[11]
EuroQol Group (1990). EuroQol—A New Facility for the Measurement of Health-Related Quality of Life. Health Policy, 16, 199-208. https://doi.org/10.1016/0168-8510(90)90421-9
[12]
Gafoor, R., Booth, H. P., & Gulliford, M. C. (2018). Antidepressant Utilisation and Incidence of Weight Gain during 10 Years’ Follow-Up: Population Based Cohort Study. BMJ, 361, k1951. https://doi.org/10.1136/bmj.k1951
[13]
Griffiths, C. A., & Griffiths, L. J. (2014). Recovery and Reliable Change Rates for Patients Scoring Severe on Depression, Anxiety or Impaired Functioning in a Psychological Therapies Service: IAPT. Mental Health Review Journal, 20, 28-35. https://doi.org/10.1108/MHRJ-06-2014-0022
[14]
Griffiths, C., Leathlean, C., Smart, D., Zafar, A., Hall, C.-L., & Deeks, S. (2021). Alpha-Stim Cranial Electrotherapy Stimulation (CES) for Anxiety Treatment: Outcomes in a United Kingdom (UK) Primary Care Practice. Open Journal of Psychiatry, 11, 186-201. https://doi.org/10.4236/ojpsych.2021.113015
[15]
Gyani, A., Shafran, R., Layard, R., & Clark, D. M. (2013). Enhancing Recovery Rates: Lessons from Year One of IAPT. Behaviour Research and Therapy, 51, 597-606. https://doi.org/10.1016/j.brat.2013.06.004
[16]
Herdman, M., Gudex, C., Lloyd, A., Janssen, M. F., Kind, P., Parkin, D. et al. (2011). Development and Preliminary Testing of the New Five-Level Version of EQ-5D (EQ-5D-5L). Quality of Life Research, 20, 1727-1736. https://doi.org/10.1007/s11136-011-9903-x
[17]
Kennerly, R. (2004). QEEG Analysis of Cranial Electrotherapy: A Pilot Study. Journal of Neurotherapy, 8, 112-112.
[18]
Kessler, R. C., Petukhova, M., Sampson, N. A., Zaslavsky, A. M., & Wittchen, H. U. (2012). Twelve-Month and Lifetime Prevalence and Lifetime Morbid Risk of Anxiety and Mood Disorders in the United States. International Journal of Methods in Psychiatric Research, 21, 169-184. https://doi.org/10.1002/mpr.1359
[19]
Kroenke, K., Spitzer, R. L., Williams, J. B., Monahan, P. O., & Löwe, B. (2007). Anxiety Disorders in Primary Care: Prevalence, Impairment, Comorbidity, and Detection. Annals of Internal Medicine, 146, 317-325. https://doi.org/10.7326/0003-4819-146-5-200703060-00004
[20]
Lingam, R., & Scott, J. (2002). Treatment Non-Adherence in Affective Disorders. Acta Psychiatrica Scandinavica, 105, 164-172. https://doi.org/10.1034/j.1600-0447.2002.1r084.x
[21]
Medical Research Council (MRC) (2000). A Framework for Development and Evaluation of Randomised Controlled Trials for Complex Interventions to Improve Health. Medical Research Council.
[22]
Morriss, R., Xydopoulos, G., Craven, M., Price, L., & Fordham, R. (2019). Clinical Effectiveness and Cost Minimisation Model of Alpha-Stim Cranial Electrotherapy Stimulation in Treatment Seeking Patients with Moderate to Severe Generalised Anxiety Disorder. Journal of Affective Disorders, 253, 426-437. https://doi.org/10.1016/j.jad.2019.04.020
[23]
NHS England (2016). General Practice Forward View. https://www.england.nhs.uk/wp-content/uploads/2016/04/gpfv.pdf
[24]
NHS England (2021). Community Mental Health Services. https://www.england.nhs.uk/mental-health/adults/cmhs/
[25]
NICE (2018). Guide to the Processes of Technology Appraisal. Guide to the Processes of Technology Appraisal. NICE.
[26]
NICE (2019a). Benzodiazepine and Z-Drug Withdrawal. https://cks.nice.org.uk/topics/benzodiazepine-z-drug-withdrawal/management/
[27]
NICE (2019b). Generalised Anxiety Disorder and Panic Disorder in Adults: Management. Clinical Guideline. Clinical Guideline [CG113]. https://www.nice.org.uk/guidance/cg113
[28]
NICE (2021). Alpha-Stim AID for Anxiety Disorders. https://www.nice.org.uk/guidance/mtg56
[29]
Peasgood, T., Brazier, J., & Papaioannou, D. (2012). A Systematic Review of the Validity and Responsiveness of EQ-5D and SF-6D for Depression and Anxiety. HEDS Discussion Paper 12/15.
[30]
Royal, S., Keeling, S., Kelsall, N., Price, L., Fordham, R., Xydopoulos, G. et al. (2022). Feasibility, Acceptability and Costs of Nurse-Led Alpha-Stim Cranial Electrostimulation to Treat Anxiety and Depression in University Students. BMC Primary Care, 23, Article No. 97. https://doi.org/10.1186/s12875-022-01681-3
[31]
Shekelle, P., Cook, I., Miake-Lye, I. M., Mak, S., Booth, M. S., Shanman, R., & Beroes, J. M. (2018). The Effectiveness and Risks of Cranial Electrical Stimulation for the Treatment of Pain, Depression, Anxiety, PTSD, and Insomnia: A Systematic Review. Department of Veterans Affairs (US). https://www.ncbi.nlm.nih.gov/books/NBK493132 https://doi.org/10.7326/M17-1970
[32]
Spitzer, R. L., Kroenke, K., Williams, J. B., & Löwe, B. (2006). A Brief Measure for Assessing Generalized Anxiety Disorder: The GAD-7. Archives of Internal Medicine, 166, 1092-1097. https://doi.org/10.1001/archinte.166.10.1092
[33]
van Hout, B., Janssen, M. F., Feng, Y. S., Kohlmann, T., Busschbach, J., Golicki, D. et al. (2012). Interim Scoring for the EQ-5D-5L: Mapping the EQ-5D-5L to EQ-5D-3L Value Sets. Value in Health, 15, 708-715. https://doi.org/10.1016/j.jval.2012.02.008
[34]
Wittchen, H. U., Jacobi, F., Rehm, J., Gustavsson, A., Svensson, M., Jönsson, B. et al. (2011). The Size and Burden of Mental Disorders and Other Disorders of the Brain in Europe 2010. European Neuropsychopharmacology, 21, 655-679. https://doi.org/10.1016/j.euroneuro.2011.07.018
