Home-based transcranial direct current stimulation in dual active treatments for symptoms of depression and anxiety: A case series

Abstract

Transcranial direct current stimulation (tDCS) is a potential treatment strategy across some psychiatric conditions. However, there is high heterogeneity in tDCS efficacy as a stand-alone treatment. To increase its therapeutic potential, researchers have begun to explore the efficacy of combining tDCS with psychological and pharmacological interventions. The current case series details the effect of 6–10 weeks of self-administered tDCS paired with a behavioral therapy smartphone app (Flow™), on depressive and anxiety symptoms, in seven patients (26–51 years old; four female) presenting distinctive psychiatric disorders (major depression, dysthymia, illness anxiety disorder, obsessive-compulsive disorder, and anxiety disorders). tDCS protocol consisted of an acute phase of daily 30 min sessions, across 10 workdays (2 weeks Monday-to-Friday; Protocol 1) or 15 workdays (3 weeks Monday-to-Friday; Protocol 2). A maintenance phase followed, with twice-weekly sessions for 4 or 3 weeks, corresponding to 18 or 21 sessions in total (Protocol 1 or 2, respectively). The Flow tDCS device uses a 2 mA current intensity, targeting the bilateral dorsolateral prefrontal cortex. The Flow app offers virtually guided behavioral therapy courses to be completed during stimulation. We assessed depressive symptoms using MADRS-S and BDI-II, anxious symptoms using STAI-Trait, acceptability using ACCEPT-tDCS, and side effects using the Adverse Effects Questionnaire, at baseline and week 6 of treatment. Six patients underwent simultaneous cognitive-behavioral psychotherapy and two were on antidepressants and benzodiazepines. According to the Reliable Change Index (RCI), for depressive symptoms, we found clinically reliable improvement in five patients using MADRS-S (out of seven; RCI: −1.45, 80% CI; RCI: −2.17 to −4.82, 95% CI; percentage change: 37.9–66.7%) and in four patients using BDI-II (out of five; RCI: −3.61 to −6.70, 95% CI; percentage change: 57.1–100%). For anxiety symptoms, clinically reliable improvement was observed in five patients (out of six; RCI: −1.79, 90% CI; RCI: −2.55 to −8.64, 95% CI; percentage change: 12.3–46.4%). Stimulation was well-tolerated and accepted, with mild tingling sensation and scalp discomfort being the most common side effects. This case series highlights the applicability, acceptability, and promising results when combining home-based tDCS with psychotherapy and pharmacotherapy to manage depression and anxiety symptoms in clinical practice.

TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study

“…2 (sham): travel, loss of interest Changes from baseline to week 2,4, 8 in the BDI-II (primary Outcome), QOLIE-31 and HAM-A score (secondary Outcome), improvement over time but no group difference S: active and sham, monitoring of technical parameters. W: different groups of medications A = yes Q = yes S = yes T = yes V = yes Sobral et al [ 28 ] Case series, open label, combination of home-based tDCS with App based psychological intervention, MDD and/or comorbidities N = 7, 4 female, 26–51 years old; Single condition, active + app-based intervention: one-size-fits-all cap, prefrontal, anode left, cathode right, 2 mA, 30 min, 18 or 21 sessions in 6 weeks Supervised training, self-administered by patients, clinical progress monitoring in person and remotely using Zoom No SAEs, most common AEs: scalp irritation, tingling, itching, and burning sensation. Adherence and acceptability overall high (ACCEPT-tDCS scores), 2 patients missed > 50% tDCS sessions (personal challenges), 1 drop-out (compliance) Changes from baseline to week 6 in: MADRS-Self rating and BDI-II, STAI-Trait clinical improvement in MADRS-S in 5 patients and in STAI-Y2 5 patients S: combination with app-based intervention W: 2 patients initiated CBT at same time as study, no control group A = yes Q = no S = yes T = no V = yes Woodham et al [ 30 ] Open label, single-arm study of home-based tDCS in MDD N = 26, 19 female, 40.9 ± 14.2 years Single condition, active tDCS, F3 anode, F4 cathode, 2 mA, 30 min, 21 sessions in 6 weeks Self-administered, research team member was present in person or by real-time video call at each session No SAEs, most common side effects were skin redness, tingling, itching, mild burning sensation, headache.…”

“…Two recent case series of interventions involving tDCS combined with app-based behavioural therapy reported antidepressant effects, feasibility and safety. [ 27 , 28 ]. Some problems of adherence, with only one patient completing the course per protocol, were also reported by Sobral and colleagues.…”

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

“…Patients in CMHTs typically have severe mental illness and more than one a mental illness diagnosis, and they may need other treatments at the same time as (Sobral et al, 2022;Woodham et al, 2022;Rimmer et al, 2022;Griffiths et al, 2023). Some participants did not use the training modules; autism, ADHD, and unwillingness to try prevented use.…”

“…Flow is a product that can be purchased by anyone over the age of 18; it is combined tDCS (delivered by Flow FL-100) and software app-based wellbeing behaviour training (training module titles include: physical exercise, nutrition, mindfulness, sleep, and choosing actions). In a case series study of Flow, reliable change index (RCI) improvements were reported in depressive symptoms in five out of seven patients with depression (Sobral et al, 2022). In a 24-participant open-label single-arm feasibility study, a significant improvement in depressive symptoms after 6 weeks of treatment was reported, which was maintained at 3 and 6 months, and most participants reported that Flow was acceptable and that they would recommend it to others (Woodham et al, 2022).…”

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

“…The commercially available product "Flow", which is combined tDCS (delivered by Flow FL-100) and software app-based well-being behaviour training (exercise, nutrition, mindfulness, sleep, choosing actions), has been subject to investigation. In a case series study, reliable change index (RCI) improvements were reported in depressive symptoms in five out of seven patients with depression (Sobral et al, 2022). In a 24-participant open-label single-arm feasibility study, there was a significant improvement in depressive symptoms after 6 weeks of treatment, which was maintained at 3 and 6 months, with most participants stating that Flow was acceptable and that they would recommend it (Woodham et al, 2022;Rimmer et al, 2022).…”