“Flow” Transcranial Direct Current Stimulation (tDCS) for Depression Treatment in a Primary Healthcare General Practice—An Open-Label Cohort Study Measuring Montgomery-?sberg Depression Rating Scale (MADRS-S) 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 delivered wellbeing behaviour therapy training. tDCS has evidence of effectiveness in treating symptoms of depression. Purpose/Aim: This post marketing study evaluated the effect of Flow on depression for primary care general practice patients with depression symptoms. Methods: Open-label patient cohort design with no control group. Inclusion criteria were aged 18 years or over and reporting depression symptoms. Participants self-administered five 30 minute tDCS sessions per week for the first three weeks, and then 3 sessions per week following this. Three, six and ten week assessment with participant self-report measure: Montgomery- ?sberg Depression Rating Scale (MADRS-S). Results: MADRS-S remission rates were between 29% - 30% at three weeks, 33% - 34% at six-weeks and 50% at 10-weeks treatment. There was a significant improvement in MADRS-S with large effect sizes at all time points. Conclusions: Flow tDCS can be delivered through a primary healthcare general practice service and patients will choose to use. Flow tDCS provides an effective depression treatment in addition and as an alternative to antidepressants and psychotherapy. tDCS has evidence as an effective depression treatment, and the widespread availability of tDCS in primary care general practice should be considered.
References
[1]
World Health Organisation (2023) Depressive Disorder (Depression)—Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/depression.
[2]
Office for National Statistics 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
[3]
Lépine, J.P. and Briley, M. (2011) The Increasing Burden of Depression. Neuropsychiatric Disease and Treatment, 7, 3-7. https://doi.org/10.2147/NDT.S19617
[4]
Vigo, D., Thornicroft, G. and 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
[5]
Atkinson-Clement, C., Junor, A. and 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
[6]
Griffiths, C., Da Silva, K.M., Leathlean, C., Jiang, H., Ang, C.S. and 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 100337. https://doi.org/10.1016/j.jadr.2022.100337
[7]
Grycuk, L., Moruzzi, F., Bardjesteh, E., Gaughran, F., Campbell, I.C. and 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 694203. https://doi.org/10.3389/fpsyg.2021.694203
[8]
Fregni, F., El-Hagrassy, M.M., Pacheco-Barrios, K., et al. (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
[9]
Jog, M.A., Anderson, C., Kubicki, A., et al. (2023) Transcranial Direct Current Stimulation (TDCS) in Depression Induces Structural Plasticity. Scientific Reports, 13, Article 2841. https://doi.org/10.1038/s41598-023-29792-6
[10]
Razza, L.B., Palumbo, P., Moffa, A.H., et al. (2020) A Systematic Review and Meta-Analysis on the Effects of Transcranial Direct Current Stimulation in Depressive Episodes. Depress Anxiety, 37, 594-608. https://doi.org/10.1002/da.23004
[11]
Chhabra, H., Bose, A., Shivakumar, V., et al. (2020) Tolerance of Transcranial Direct Current Stimulation in Psychiatric Disorders: An Analysis of 2000+ Sessions. Psychiatry Research, 284, Article 112744. https://doi.org/10.1016/j.psychres.2020.112744
[12]
Gordon, M.S., Dux, P.E. and 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
[13]
Mutz, J., Edgcumbe, D.R., Brunoni, A.R. and 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
[14]
Mutz, J., Vipulananthan, V., Carter, B., Hurlemann, R., Fu, C.H. and 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. British Medical Journal, 364, L1079. https://doi.org/10.1136/bmj.l1079
[15]
Moffa, A.H., Martin, D., Alonzo, A., et al. (2020) Efficacy and Acceptability of Transcranial Direct Current Stimulation (TDCS) for Major Depressive Disorder: An Individual Patient Data Meta-Analysis. Progress in Neuro-Psychopharmacology & Biological Psychiatry, 99, Article 109836. https://doi.org/10.1016/j.pnpbp.2019.109836
[16]
NICE (2023) Flow Transcranial Direct Current Stimulation for Treating Depression. https://transformingmindsolutions.com/flow-transcranial-direct-current-stimulation-for-treating-depression/
[17]
Woodham, R.D., Rimmer, R.M., Young, A.H. and 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
[18]
Griffiths, C., da Silva, K.M., et al. (2024) Flow Transcranial Direct Current Stimulation (TDCS) for Depression Treatment in a Primary Healthcare General Practice— Depression, Functioning, and Health-Related Quality of Life Outcomes. Open Journal of Depression, 13, 25-39. https://doi.org/10.4236/ojd.2024.132003
[19]
Woodham, R.D., Selvaraj, S., Lajmi, N., et al. (2023) Home-Based Transcranial Direct Current Stimulation RCT in Major Depression. https://doi.org/10.1101/2023.11.27.23299059
[20]
Rimmer, R.M., Woodham, R.D., Cahill, S. and 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
[21]
Griffiths, C., Walker, K., Jiang, H., Noel-Johnson, A. and 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
[22]
Griffiths, C., Walker, K. and 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
[23]
Rush, A.J., Trivedi, M.H., Wisniewski, S.R., et al. (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
[24]
NHS Digital (2021) 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
[25]
Hengartner, M.P. and 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 373735. https://doi.org/10.3389/fpsyt.2018.00517
[26]
Cascade, E., Kalali, A.H. and Kennedy, S.H. (2009) Real-World Data on SSRI Antidepressant Side Effects. Psychiatry (Edgmont), 6, 16-18.
[27]
Mark, T.L., Joish, V.N., Hay, J.W., Sheehan, D.V., Johnston, S.S. and 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
[28]
Mochcovitch, M.D., da Rocha Freire, R.C., Garcia, R.F. and 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
[29]
Hansen, R., Gaynes, B., et al. (2008) Meta-Analysis of Major Depressive Disorder Relapse and Recurrence with Second-Generation Antidepressants. Psychiatric Services, 59, 1121-1130. https://doi.org/10.1176/appi.ps.59.10.1121
[30]
Davies, J. and 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
[31]
Hengartner, M.P. and 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
[32]
Gyani, A., Shafran, R., Layard, R. and 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
[33]
Griffiths, C.A. and 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
[34]
Bandelow, B., Sagebiel, A., Belz, M., Görlich, Y., Michaelis, S. and 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
[35]
Svanborg, P. and Åsberg, M. (2001) A Comparison Between the Beck Depression Inventory (BDI) and the Self-Rating Version of the Montgomery Åsberg Depression Rating Scale (MADRS). Journal of Affective Disorders, 64, 203-216. https://doi.org/10.1016/S0165-0327(00)00242-1
[36]
Fantino, B. and Moore, N. (2009) The Self-Reported Montgomery-Åsberg Depression Rating Scale Is a Useful Evaluative Tool in Major Depressive Disorder. BMC Psychiatry, 9, 1-6. https://doi.org/10.1186/1471-244X-9-26
[37]
Jakubovski, E., Johnson, J.A., Nasir, M., Müller-Vahl, K. and Bloch, M.H. (2019) Systematic Review and Meta-Analysis: Dose-Response Curve of SSRIs and SNRIs in Anxiety Disorders. Depress Anxiety, 36, 198-212. https://doi.org/10.1002/da.22854
[38]
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#:~:text=the%20NHS%20Community%20Mental%20Health,support%20by%202023%20to%202024