Self-Administered “Flow” Transcranial Direct Current Stimulation (tDCS) Depression Treatment in a Crisis Resolution & Home Treatment (CRT) Service: Functioning, and Health-Related Quality of Life Outcomes
Background: Transcranial direct current stimulation (tDCS) has research evidence that it can reduce symptoms of depression. 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. Purpose/aim: The purpose of this study was to investigate if Flow can be introduced to a Crisis Resolution & Home Treatment (CRT) service and the impact of Flow in treating depression. The study addresses the questions: 1) “what are the depression reliable improvement and remission rates?” and 2) “can Flow significantly reduce depressive symptoms and improve real world functioning (every-day, social and occupational functioning) and health-related quality of life?”. Methods: An open-label patient cohort design with no control group. Pre-intervention and 6-week follow-up intervention assessments using the participant self-report measures: Patient Health Questionnaire (PHQ-9), Work and Social Adjustment Scale (WSAS), and EuroQol five-dimension (EQ-5D-5L). Participants were 49 CRT patients, 19 males and 30 females, with an age range of 20 to 66 years, and average age of 42 years. Results: PHQ-9 reliable improvement and remission rates were 57.1% and 14.3%. PHQ-9 scores significantly improved, from 23.1 (SD 3.44) to 14.8 (SD 6.82) at 6 weeks, with a large effect size. PHQ-9 suicide/self-harm related question significantly improved from 2.51 (SD 0.77) to 1.08 (SD 1.17), with a large effect size. WSAS scores significantly improved, from 33.6 (SD 5.22) to 21.9 (SD 10.82) at 6 weeks, with a large effect size. EQ-5D-5L results showed significant improvements in the health index score, global assessment of health EQ-VAS from 34.2 (22.26) to 51.6 (24.95), and three EQ-5D-5L dimensions (“self-care”, “usual activity”, and “anxiety/depression”). Conclusion: A CRT service effectively integrated Flow tDCS treatment. Flow was beneficial in terms of improving functioning and quality of life and reducing depression symptoms and thoughts of suicide/self-harm. Flow FL100 tDCS and wellbeing behaviour therapy training could be offered through all CRT services to treat depression, reduce thoughts of suicide/self-harm, enable better functioning, and improve quality of life.
References
[1]
World Health Organisation (WHO) (2023) Depressive Disorder (Depression)—Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/depression
[2]
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
[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]
Harris, E.C. and Barraclough, B. (1997) Suicide as an Outcome for Mental Disorders: A Meta-Analysis. British Journal of Psychiatry, 170, 205-228. https://doi.org/10.1192/bjp.170.3.205
[6]
Public Health England (2018) Severe Mental Illness (SMI) and Physical Health in E-qualities: Briefing. https://www.gov.uk/government/publications/severe-mental-illness-smi-physical-health-inequalities/severe-mental-illness-and-physical-health-inequalities-briefing
[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 ID: 694203. https://doi.org/10.3389/fpsyg.2021.694203
[8]
Fregni, F., El-Hagrassy, M.M., Pacheco-Barrios, K., Carvalho, S., Leite, J., Simis, M., et al. (2020) 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., Boucher, M., Leaver, A., Hellemann, G., et al. (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
[10]
Mutz, J., Edgcumbe, D.R., Brunoni, A.R. and Fu, C.H.Y. (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
[11]
Mutz, J., Vipulananthan, V., Carter, B., Hurlemann, R., Fu, C.H.Y. 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. BMJ, 364, l1079. https://doi.org/10.1136/bmj.l1079
[12]
Moffa, A.H., Martin, D., Alonzo, A., Bennabi, D., Blumberger, D.M., Benseñor, I.M., 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 and Biological Psychiatry, 99, Article ID: 109836. https://doi.org/10.1016/j.pnpbp.2019.109836
[13]
Razza, L.B., Palumbo, P., Moffa, A.H., Carvalho, A.F., Solmi, M., Loo, C.K., et al. (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
[14]
Chhabra, H., Bose, A., Shivakumar, V., Agarwal, S.M., Sreeraj, V.S., Shenoy, S., et al. (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
[15]
Berlim, M.T. and Turecki, G. (2007) What Is the Meaning of Treatment Resistant/Refractory Major Depression (TRD)? A Systematic Review of Current Randomized Trials. European Neuropsychopharmacology, 17, 696-707. https://doi.org/10.1016/j.euroneuro.2007.03.009
[16]
Li, J., Kung, S., Croarkin, P. and Lapid, M. (2024) Transcranial Direct Current Stimulation (tDCS) for Treatment Resistant Depression (TRD): A Systematic Review. The American Journal of Geriatric Psychiatry, 32, S99. https://doi.org/10.1016/j.jagp.2024.01.181
[17]
Woodham, R.D., Selvaraj, S., Lajmi, N., Hobday, H., Sheehan, G., Ghazi-Noori, A., et al. (2024) Home-Based Transcranial Direct Current Stimulation Treatment for Major Depressive Disorder: A Fully Remote Phase 2 Randomized Sham-Controlled Trial. Nature Medicine. https://doi.org/10.1038/s41591-024-03305-y
[18]
Griffiths, C., Silva, K.M.d., Jiang, H., Smart, D. and Zafar, A. (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]
Griffiths, C., Jiang, H., Smart, D. and Zafar, A. (2024) “Flow” Transcranial Direct Current Stimulation (tDCS) for Depression Treatment in a Primary Healthcare General Practice—An Open-Label Cohort Study Measuring Montgomery-Åsberg Depression Rating Scale (MADRS-S) Outcomes. Open Journal of Psychiatry, 14, 386-399. https://doi.org/10.4236/ojpsych.2024.144024
[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.
[21]
Griffiths, C., Walker, K., Jiang, H. and Noel-Johnson, 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]
Montgomery, S.A. and Åsberg, M. (1979) A New Depression Scale Designed to Be Sensitive to Change. British Journal of Psychiatry, 134, 382-389. https://doi.org/10.1192/bjp.134.4.382
[24]
Marks, I. (1986) Behavioural Psychotherapy: Maudsley Pocket Book of Clinical Management. John Wright.
[25]
Mundt, J.C., Marks, I.M., Shear, M.K. and Greist, J.M. (2002) The Work and Social Adjustment Scale: A Simple Measure of Impairment in Functioning. British Journal of Psychiatry, 180, 461-464. https://doi.org/10.1192/bjp.180.5.461
[26]
Hammond, G.C., Croudace, T.J., Radhakrishnan, M., Lafortune, L., Watson, A., McMillan-Shields, F., et al. (2012) Comparative Effectiveness of Cognitive Therapies Delivered Face-to-Face or over the Telephone: An Observational Study Using Propensity Methods. PLOS ONE, 7, e42916. https://doi.org/10.1371/journal.pone.0042916
[27]
Kroenke, K., Spitzer, R.L. and Williams, J.B.W. (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
[28]
Richards, D.A. and 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
[29]
EuroQol Group (1990) EuroQol—A New Facility for the Measurement of Health-Related Quality of Life. Health Policy, 16, 199-208.
[30]
EuroQol Research Foundation (2024) EQ-5D-5L|About. https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/
[31]
Peasgood, T., Brazier, J. and 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. https://doi.org/10.31234/osf.io/xfvwq
[32]
Brooks, R. (1996) Euroqol: The Current State of Play. Health Policy, 37, 53-72. https://doi.org/10.1016/0168-8510(96)00822-6
[33]
Herdman, M., Gudex, C., Lloyd, A., Janssen, M., 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
[34]
NICE (2019) Position Statement on Use of the EQ-5D-5L Value Set for England (up-Dated October 2019). https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/eq-5d-5l
[35]
Griffiths, C.A. (2009) Sense of Coherence and Mental Health Rehabilitation. Clinical Rehabilitation, 23, 72-78. https://doi.org/10.1177/0269215508095360
[36]
Morgan, V.A., Waterreus, A., Jablensky, A., Mackinnon, A., McGrath, J.J., Carr, V. and Saw, S. (2011) People Living with Psychotic Illness 2010. Australian Government.
[37]
Fliege, H., Lee, J., Grimm, A. and Klapp, B.F. (2009) Risk Factors and Correlates of Deliberate Self-Harm Behavior: A Systematic Review. Journal of Psychosomatic Research, 66, 477-493. https://doi.org/10.1016/j.jpsychores.2008.10.013
[38]
Hawton, K., Saunders, K., Topiwala, A. and Haw, C. (2013) Psychiatric Disorders in Patients Presenting to Hospital Following Self-Harm: A Systematic Review. Journal of Affective Disorders, 151, 821-830. https://doi.org/10.1016/j.jad.2013.08.020
[39]
Victor, S.E. and Klonsky, E.D. (2014) Correlates of Suicide Attempts among Self-Injurers: A Meta-Analysis. Clinical Psychology Review, 34, 282-297. https://doi.org/10.1016/j.cpr.2014.03.005
[40]
Hawton, K. and Van Heeringen, K. (2000) The International Handbook of Suicide and Attempted Suicide. John Wiley & Sons.
[41]
Yiu, H.W., Rowe, S. and Wood, L. (2021) A Systematic Review and Meta-Analysis of Psychosocial Interventions Aiming to Reduce Risks of Suicide and Self-Harm in Psychiatric Inpatients. Psychiatry Research, 305, Article ID: 114175. https://doi.org/10.1016/j.psychres.2021.114175
[42]
Huang, X., Harris, L.M., Funsch, K.M., Fox, K.R. and Ribeiro, J.D. (2022) Efficacy of Psychotropic Medications on Suicide and Self-Injury: A Meta-Analysis of Randomized Controlled Trials. Translational Psychiatry, 12, Article No. 400. https://doi.org/10.1038/s41398-022-02173-9
[43]
Cochrane Common Mental Disorders Group, Hawton, K., Witt, K.G., Taylor Salisbury, T.L., Arensman, E., Gunnell, D. and van Heeringen, K. (1996) Pharmacological Interventions for Self-Harm in Adults. Cochrane Database of Systematic Reviews, No. 9, 1-63.
[44]
Makowska, I., Rymarczyk, K., Puzio, D., Pałka-Szafraniec, K. and Garnier, J. (2022) Emotional Regulation in Non-Suicidal Self-Injury—Research on the Use of Transcranial Direct Current Stimulation (tDCS). European Psychiatry, 65, S445-S446. https://doi.org/10.1192/j.eurpsy.2022.1132
[45]
Jakubovski, E., Johnson, J.A., Nasir, M., Müller-Vahl, K. and Bloch, M.H. (2018) 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
[46]
Wang, J., Luo, H., Schülke, R., Geng, X., Sahakian, B.J. and Wang, S. (2021) Is Transcranial Direct Current Stimulation, Alone or in Combination with Antidepressant Medications or Psychotherapies, Effective in Treating Major Depressive Disorder? A Systematic Review and Meta-Analysis. BMC Medicine, 19, Article No. 319. https://doi.org/10.1186/s12916-021-02181-4
[47]
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
