“Flow” Transcranial Direct Current Stimulation (tDCS) for Depression Treatment in a Primary Healthcare General Practice—Depression, Functioning, and Health-Related Quality of Life Outcomes
Background: Flow FL-100 is a transcranial direct current stimulation (tDCS) device self-administered by a patient at home in combination with a software application that delivers wellbeing behaviour therapy training. tDCS has evidence of effectiveness in treating symptoms of depression. This post marketing study evaluated the effect of Flow on depression, functioning, and health-related quality of life for primary care general practice patients with depression symptoms. Methods: Open-label patient cohort design with no control group. Thirty-one adult patients completed six weeks of Flow treatment. Average age 45.6 years (SD = 13.72) range from 20-75 years; 24 (77.4%) females and six males (23.6%). Pre- and post-intervention assessment with participant self-report measures: Patient Health Questionnaire (PHQ-9), Work and Social Adjustment Scale (WSAS), and European Quality of Life Five Dimension (EQ-5D-5L). Results: PHQ-9 reliable improvement and remission rates were 58.1% and 32.3%. There was a significant improvement in PHQ-9 and WSAS with large effect sizes. EQ-5D-5L results showed significant improvements in three dimensions and the health index score with medium effect sizes. Conclusion: Flow tDCS can be delivered through a primary healthcare general practice service and patients use it as prescribed and complete treatment course. tDCS has evidence as an effective depression treatment, the widespread availability of tDCS in primary care general practice should be considered.
References
[1]
Atkinson-Clement, C., Junor, A., & Kaiser, M. (2024). A Large-Scale Online Survey of Patients and the General Public: Preferring Safe and Noninvasive Neuromodulation for Mental Health. https://doi.org/10.1101/2024.01.10.24301043
[2]
Bandelow, B., Sagebiel, A., Belz, M., Görlich, Y., Michaelis, S., & Wedekind, D. (2018). Enduring Effects of Psychological Treatments for Anxiety Disorders: Meta-Analysis of Follow-Up Studies. The British Journal of Psychiatry, 212, 333-338. https://doi.org/10.1192/bjp.2018.49
[3]
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
[4]
Cascade, E., Kalali, A. H., & Kennedy, S. H. (2009). Real-World Data on SSRI Antidepressant Side Effects. Psychiatry (Edgmont), 6, 16-18.
[5]
Chhabra, H., Bose, A., Shivakumar, V., Agarwal, S. M., Sreeraj, V. S., Shenoy, S., & Venkatasubramanian, G. (2020). Tolerance of Transcranial Direct Current Stimulation in Psychiatric Disorders: An Analysis of 2000 Sessions. Psychiatry Research, 284, Article ID: 112744. https://doi.org/10.1016/j.psychres.2020.112744
[6]
Culpepper, L., Muskin, P. R., & Stahl, S. M. (2015). Major Depressive Disorder: Understanding the Significance of Residual Symptoms and Balancing Efficacy with Tolerability. The American Journal of Medicine, 128, S1-S15. https://doi.org/10.1016/j.amjmed.2015.07.001
[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 for Health and Social Care (2023). Mental Health and Wellbeing Plan: Discussion Paper. https://www.gov.uk/government/calls-for-evidence/mental-health-and-wellbeing-plan-discussion-paper-and-call-for-evidence/mental-health-and-wellbeing-plan-discussion-paper
[9]
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
[10]
Fregni, F., El-Hagrassy, M. M., Pacheco-Barrios, K., Carvalho, S., Leite, J., Simis, M., & Brunoni, A. R. (2021). Evidence-Based Guidelines and Secondary Meta-Analysis for the Use of Transcranial Direct Current Stimulation in Neurological and Psychiatric Disorders. International Journal of Neuropsychopharmacology, 24, 256-313. https://doi.org/10.1093/ijnp/pyaa051
[11]
Gordon, M. S., Dux, P. E., & Filmer, H. L. (2021). Not Quite All in Our Head: Intervention Is a Better Predictor of tDCS Mind-Wandering Effects than Subjective Beliefs about Experimental Results. https://doi.org/10.1101/2021.11.14.468553
[12]
Griffiths, C. A. (2009). Sense of Coherence and Mental Health Rehabilitation. Clinical Rehabilitation Journal, 23, 72-78. https://doi.org/10.1177/0269215508095360
[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., da Silva, K. M., Leathlean, C., Jiang, H., Ang, C. S., & Searle, R. (2022). Investigation of Physical Activity, Sleep, and Mental Health Recovery in Treatment Resistant Depression (TRD) Patients Receiving Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment. Journal of Affective Disorders Reports, 8, Article ID: 100337. https://www.sciencedirect.com/science/article/pii/S2666915322000300?via=ihub https://doi.org/10.1016/j.jadr.2022.100337
[15]
Griffiths, C., Walker, K., & Willis, A. (2024). A Qualitative Study Exploring the Experience and Value of Flow Transcranial Direct Current Stimulation (tDCS) and Behaviour Therapy Training Software Used at Home for Community Mental Health Team (CMHT) Patients with Symptoms of Depression. Open Journal of Depression, 13, 6-23. https://doi.org/10.4236/ojd.2024.131002
[16]
Griffiths, C., Walker, K., Jiang, H., Noel-Johnson, A., & Zafar, A. (2023). A Qualitative Study Exploring the Experience and Value of “Flow” Transcranial Direct Current Stimulation (tDCS) Device and Behaviour Therapy Training Software Application at Home for Symptoms of Depression. Open Journal of Depression, 12, 65-86. https://doi.org/10.4236/ojd.2023.124007
[17]
Grycuk, L., Moruzzi, F., Bardjesteh, E., Gaughran, F., Campbell, I. C., & Schmidt, U. (2021). Participant Experiences of Transcranial Direct Current Stimulation (tDCS) as a Treatment for Antipsychotic Medication Induced Weight Gain. Frontiers in Psychology, 12, Article ID: 694203. https://doi.org/10.3389/fpsyg.2021.694203
[18]
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
[19]
Hammond, G. C., Croudace, T. J., Radhakrishnan, M., Lafortune, L., Watson, A., McMillan-Shields, F., Jones, P., & Laks, J. (2012). Comparative Effectiveness of Cognitive Therapies Delivered Face-to-Face or over the Telephone: An Observational Evaluation Using Propensity Methods. PLOS ONE, 7, e42916. https://doi.org/10.1371/journal.pone.0042916
[20]
Hengartner, M. P., & Plöderl, M. (2018). Statistically Significant Antidepressant-Placebo Differences on Subjective Symptom-Rating Scales Do Not Prove That the Drugs Work: Effect Size and Method Bias Matter! Frontiers in Psychiatry, 9, Article ID: 373735. https://doi.org/10.3389/fpsyt.2018.00517
[21]
Hengartner, M. P., & Plöderl, M. (2019). Reply to the Letter to the Editor: “Newer-Generation Antidepressants and Suicide Risk: Thoughts on Hengartner and Plöderl’s Re-Analysis”. Psychotherapy and Psychosomatics, 88, 373-374. https://doi.org/10.1159/000502485
[22]
Herdman, M., Gudex, C., Lloyd, A., Janssen, M. F., Kind, P., Parkin, D., & Badia, X. (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
[23]
Jakubovski, E., Johnson, J. A., Nasir, M., Müller-Vahl, K., & Bloch, M. H. (2019). Systematic Review and Meta-Analysis: Dose-Response Curve of SSRIs and SNRIs in Anxiety Disorders. Depression and Anxiety, 36, 198-212. https://doi.org/10.1002/da.22854
[24]
Jog, M. A., &erson, C., Kubicki, A., Boucher, M., Leaver, A., Hellemann, G., & Narr, K. (2023). Transcranial Direct Current Stimulation (tDCS) in Depression Induces Structural Plasticity. Scientific Reports, 13, Article No. 2841. https://doi.org/10.1038/s41598-023-29792-6
[25]
Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: Validity of a Brief Depression Severity Measure. Journal of General Internal Medicine, 16, 606-613. https://doi.org/10.1046/j.1525-1497.2001.016009606.x
[26]
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
[27]
Lépine, J. P., & Briley, M. (2011). The Increasing Burden of Depression. Neuropsychiatric Disease and Treatment, 7, 3-7. https://doi.org/10.2147/NDT.S19617
[28]
Mark, T. L., Joish, V. N., Hay, J. W., Sheehan, D. V., Johnston, S. S., & Cao, Z. (2011). Antidepressant Use in Geriatric Populations: The Burden of Side Effects and Interactions and Their Impact on Adherence and Costs. The American Journal of Geriatric Psychiatry, 19, 211-221. https://doi.org/10.1097/JGP.0b013e3181f1803d
[29]
Marks, I. (1986). Behavioural Psychotherapy. John Wright.
[30]
Mochcovitch, M. D., da Rocha Freire, R. C., Garcia, R. F., & Nardi, A. E. (2017). Can Long-Term Pharmacotherapy Prevent Relapses in Generalized Anxiety Disorder? A Systematic Review. Clinical Drug Investigation, 37, 737-743. https://doi.org/10.1007/s40261-017-0528-x
[31]
Moffa, A. H., Martin, D., Alonzo, A., Bennabi, D., Blumberger, D. M., Bensenor, I. M., & Brunoni, A. R. (2020). Efficacy and Acceptability of Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorder: An Individual Patient Data Meta-Analysis. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 99, Article ID: 109836. https://doi.org/10.1016/j.pnpbp.2019.109836
[32]
Montgomery, S. A., & Asberg, M. (1979). A New Depression Scale Designed to Be Sensitive to Change. The British Journal of Psychiatry, 134, 382-389. https://doi.org/10.1192/bjp.134.4.382
[33]
Mundt, J. C., Marks, I. M., Shear, M. K., & Greist, J. (2002). The Work and Social Adjustment Scale: A Simple Measure of Impairment in Functioning. The British Journal of Psychiatry, 180, 461-464. https://doi.org/10.1192/bjp.180.5.461
[34]
Mutz, J., Edgcumbe, D. R., Brunoni, A. R., & Fu, C. H. (2018). Efficacy and Acceptability of Non-Invasive Brain Stimulation for the Treatment of Adult Unipolar and Bipolar Depression: A Systematic Review and Meta-Analysis of Randomised Sham-Controlled Trials. Neuroscience & Biobehavioral Reviews, 92, 291-303. https://doi.org/10.1016/j.neubiorev.2018.05.015
[35]
Mutz, J., Vipulananthan, V., Carter, B., Hurlemann, R., Fu, C. H., & Young, A. H. (2019). Comparative Efficacy and Acceptability of Non-Surgical Brain Stimulation for the Acute Treatment of Major Depressive Episodes in Adults: Systematic Review and Network Meta-Analysis. BMJ, 364, l1079. https://doi.org/10.1136/bmj.l1079
[36]
NHS Digital (2022). Psychological Therapies, Annual Report on the Use of IAPT Services-England, 2021-22. https://digital.nhs.uk/data-and-information/publications/statistical/psychological-therapies-annual-reports-on-the-use-of-iapt-services/annual-report-2021-22
[37]
NICE (2019). Position Statement on Use of the EQ-5D-5L Value Set for England. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/eq-5d-5l
[38]
NICE (2023). Flow Transcranial Direct Current Stimulation for Treating Depression. Medtech Innovation Briefing [MIB324]. https://www.nice.org.uk/advice/mib324
[39]
Office for National Statistics (2022). Cost of Living and Depression in Adults, Great Britain: 29 September to 23 October 2022. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/mentalhealth/articles/costoflivinganddepressioninadultsgreatbritain/29septemberto23october2022
[40]
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.
[41]
Razza, L. B., Palumbo, P., Moffa, A. H., Carvalho, A. F., Solmi, M., Loo, C. K., & Brunoni, A. R. (2020). A Systematic Review and Meta-Analysis on the Effects of Transcranial Direct Current Stimulation in Depressive Episodes. Depression and Anxiety, 37, 594-608. https://doi.org/10.1002/da.23004
[42]
Richards, D. A., & Borglin, G. (2011). Implementation of Psychological Therapies for Anxiety and Depression in Routine Practice: Two Year Prospective Cohort Study. Journal of Affective Disorders, 133, 51-60. https://doi.org/10.1016/j.jad.2011.03.024
[43]
Rimmer, R. M., Woodham, R. D., Cahill, S., & Fu, C. H. (2022). Acceptability of Community-Based Transcranial Direct Current Stimulation (tDCS) in Major Depression: Mixed Methods Analysis of Individual Experiences. https://doi.org/10.31234/osf.io/xfvwq
[44]
Rush, A. J., Trivedi, M. H., Wisniewski, S. R., Nierenberg, A. A., Stewart, J. W., Warden, D., & Fava, M. (2006). Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR* D Report. American Journal of Psychiatry, 163, 1905-1917. https://doi.org/10.1176/ajp.2006.163.11.1905
[45]
Van Hout, B., Janssen, M. F., Feng, Y. S., Kohlmann, T., Busschbach, J., Golicki, D., & Pickard, A. S. (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
[46]
Vigo, D., Thornicroft, G., & Atun, R. (2016). Estimating the True Global Burden of Mental Illness. The Lancet Psychiatry, 3, 171-178. https://doi.org/10.1016/S2215-0366(15)00505-2
[47]
Woodham, R. D., Rimmer, R. M., Young, A. H., & Fu, C. H. (2022). Adjunctive Home-Based Transcranial Direct Current Stimulation Treatment for Major Depression with Real-Time Remote Supervision: An Open-Label, Single-Arm Feasibility Study with Long Term Outcomes. Journal of Psychiatric Research, 153, 197-205. https://doi.org/10.1016/j.jpsychires.2022.07.026
[48]
Woodham, R. D., Selvaraj, S., Lajmi, N., Hobday, H., Sheehan, G., Ghazi-Noori, A. R., & Fu, C. H. (2023). Home-Based Transcranial Direct Current Stimulation RCT in Major Depression. https://doi.org/10.1101/2023.11.27.23299059
[49]
World Health Organization (WHO) (2023). Depressive Disorder (Depression)—Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/depression
