A study protocol for an ongoing multi-arm, randomized, double-blind, sham-controlled clinical trial with digital features, using portable transcranial electrical stimulation and internet-based behavioral therapy for major depression disorders: The PSYLECT study

Borrione, Lucas; Cirillo, Patricia; Aparicio, Luana V Marotti; Cavendish, Beatriz Araújo; Valiengo, Leandro; Moura, D O; Souza, Juliana Pereira de; Luethi, Matthias S.; Klein, Izio; Bariani, Bruna; Neto, José Gallucci; Suen, Paulo; Padberg, Frank; Goerigk, Stephan; Vanderhasselt, Marie‐Anne; Deng, Zhi‐De; O’Shea, Jacinta; Lotufo, Paulo A; Brunoni, André R.

doi:10.1080/14737175.2022.2083959

Cited by 5 publications

(6 citation statements)

References 56 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

Section: Methodsmentioning

confidence: 99%

“…Participants could spend additional time in the application when completing daily diaries. All content was offered in Brazilian Portuguese and curated by our team . The sham intervention consisted of free internet browsing delivered through the same interface.…”

Section: Methodsmentioning

confidence: 99%

“…The Portable Transcranial Electrical Stimulation and Internet-Based Behavioral Therapy for Major Depression Study (PSYLECT) trial design and rationale have been previously published. 17 No major changes occurred from the original protocol, which can be found in Supplement 1. The study was approved by the Comitê de Ética em Pesquisa do Hospital Universitário da USP and Comitê de Ética em Pesquisa do Hospital das Clínicas da Faculdade de Medicina da USP and national ethics committees, is registered in ClinicalTrials.gov (NCT04889976), and abides by the Brazilian (Lei Geral de Proteção de Dados) and international data protection laws.…”

Section: Overviewmentioning

confidence: 99%

“…All content was offered in Brazilian Portuguese and curated by our team. 17 The sham intervention consisted of free internet browsing delivered through the same interface.…”

Section: Meaningmentioning

confidence: 99%

See 3 more Smart Citations

Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode

Borrione,

Cavendish,

Aparicio

et al. 2024

JAMA Psychiatry

Self Cite

View full text Add to dashboard Cite

ImportanceTranscranial direct current stimulation (tDCS) is moderately effective for depression when applied by trained staff. It is not known whether self-applied tDCS, combined or not with a digital psychological intervention, is also effective.ObjectiveTo determine whether fully unsupervised home-use tDCS, combined with a digital psychological intervention or digital placebo, is effective for a major depressive episode.Design, Setting, and ParticipantsThis was a double-blinded, sham-controlled, randomized clinical trial with 3 arms: (1) home-use tDCS plus a digital psychological intervention (double active); (2) home-use tDCS plus digital placebo (tDCS only), and (3) sham home-use tDCS plus digital placebo (double sham). The study was conducted between April 2021 and October 2022 at participants’ homes and at Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil. Included participants were aged 18 to 59 years with major depression and a Hamilton Depression Rating Scale, 17-item version (HDRS-17), score above 16, a minimum of 8 years of education, and access to a smartphone and internet at home. Exclusion criteria were other psychiatric disorders, except for anxiety; neurologic or clinical disorders; and tDCS contraindications.InterventionstDCS was administered in 2-mA, 30-minute prefrontal sessions for 15 consecutive weekdays (1-mA, 90-second duration for sham) and twice-weekly sessions for 3 weeks. The digital intervention consisted of 46 sessions based on behavioral therapy. Digital placebo was internet browsing.Main Outcomes and MeasuresChange in HDRS-17 score at week 6.ResultsOf 837 volunteers screened, 210 participants were enrolled (180 [86%] female; mean [SD] age, 38.9 [9.3] years) and allocated to double active (n = 64), tDCS only (n = 73), or double sham (n = 73). Of the 210 participants enrolled, 199 finished the trial. Linear mixed-effects models did not reveal statistically significant group differences in treatment by time interactions for HDRS-17 scores, and the estimated effect sizes between groups were as follows: double active vs tDCS only (Cohen d, 0.05; 95% CI, −0.48 to 0.58; P = .86), double active vs double sham (Cohen d, −0.20; 95% CI, −0.73 to 0.34; P = .47), and tDCS only vs double sham (Cohen d, −0.25; 95% CI, −0.76 to 0.27; P = .35). Skin redness and heat or burning sensations were more frequent in the double active and tDCS only groups. One nonfatal suicide attempt occurred in the tDCS only group.Conclusions and RelevanceUnsupervised home-use tDCS combined with a digital psychological intervention or digital placebo was not found to be superior to sham for treatment of a major depressive episode in this trial.Trial RegistrationClinicalTrials.gov Identifier: NCT04889976

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Overviewmentioning

confidence: 99%

“…All content was offered in Brazilian Portuguese and curated by our team. 17 The sham intervention consisted of free internet browsing delivered through the same interface.…”

Section: Meaningmentioning

confidence: 99%

See 2 more Smart Citations

Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode

Borrione,

Cavendish,

Aparicio

et al. 2024

JAMA Psychiatry

Self Cite

View full text Add to dashboard Cite

show abstract

“…Antidepressant effects were promising and long lasting with 91.3% clinical response and 73.9% remission rates even in the 6-month follow up (28). In addition to the results of these pilot studies, case reports, and smaller monocentric single blinded trials, study protocols of larger RCTs on this topic even with the combination of tDCS with cognitive training or behavioural therapy have been published, though the results of these trials are expected in the future (29,30).…”

Section: Discussionmentioning

confidence: 99%

Transcranial Direct Current Stimulation as Treatment for Major Depression in a Home Treatment Setting (HomeDC Trial): Study Design and Methodology of a Double-blind, Placebo-controlled Pilotstudy

Kumpf

Ezim

Stadler

et al. 2022

Preprint

Self Cite

View full text Add to dashboard Cite

Introduction Transcranial direct current stimulation (tDCS) of prefrontal cortex regions has been reported to exert therapeutic effects in major depressive disorder (MDD). Due to its beneficial safety profile, its easy mode of application and its cost-effectiveness, tDCS has recently been proposed for treatment at home, which would offer new chances for regionally wide spread and long-term application. However, tDCS at home has to meet new methodological challenges of handling and adherence, and data from randomized controlled trials (RCT) investigating this mode of application are still lacking. In this pilot RCT, we therefore investigate feasibility, safety and effectiveness of a new tDCS application set-up in MDD. Methods and analysis The HomeDC trial will be conducted as a double-blind, placebo-controlled, parallel-group design trial. Thirty-two patients with MDD will be randomized to active or sham tDCS. Patients will self-administer prefrontal tDCS for 6 weeks. Active tDCS will be conducted with anode over F3, cathode over F4, for 5 sessions/week, with a duration of 30min/day and 2mA stimulation intensity, whereas sham tDCS follows the identical protocol in electrode montage and timing but with ramp-in and ramp-out periods only without intermittent stimulation. Both conditions will be administered as monotherapy or adjunctive treatment to a stable dose of antidepressant medication. Feasibility, effectiveness and safety will be assessed, and adjunctive fMRI and e-field modelling will be conducted at baseline. Discussion For the HomeDC trial, technical requirements of a placebo-controlled trial in a home-based treatment setting with tDCS have been established. It addresses the crucial points of a home-based treatment approach with tDCS: uniform electrode positioning and frequent monitoring of stimulation parameters and adherence, ensuring an appropriate home treatment environment. This study will allow identifying constraints and further critical topics of this novel mode of application. Trial Registration www.clinicaltrials.gov. Trial registration number: NCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505

show abstract

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

Kumpf

Palm²,

Eder

et al. 2023

Eur Arch Psychiatry Clin Neurosci

Self Cite

View full text Add to dashboard Cite

The application of transcranial direct current stimulation (tDCS) at home for the treatment of major depressive disorder (MDD) is the subject of current clinical trials. This is due to its positive safety profile, cost-effectiveness, and potential scalability for a wide outreach in clinical practice. Here, we provide a systematic review of the available studies and also a report on the results of a randomized controlled trial (RCT) on tDCS at home for the treatment of MDD. This trial had to be prematurely terminated due to safety concerns. The HomeDC trial is a double-blinded, placebo-controlled, parallel-group study. Patients with MDD (DSM-5) were randomized to active or sham tDCS. Patients conducted tDCS at home for 6 weeks with 5 sessions/week (30 min at 2 mA) anode over F3, cathode over F4. Sham tDCS resembled active tDCS, with ramp-in and ramp-out periods, but without intermittent stimulation. The study was prematurely terminated due to an accumulation of adverse events (AEs, skin lesions), so that only 11 patients were included. Feasibility was good. Safety monitoring was not sufficient enough to detect or prevent AEs within an appropriate timeframe. Regarding antidepressant effects, the reduction in depression scales over time was significant. However, active tDCS was not superior to sham tDCS in this regard. Both the conclusions from this review and the HomeDC trial show that there are several critical issues with the use of tDCS at home that need to be addressed. Nevertheless the array of transcranial electric simulation (TES) methods that this mode of application offers, including tDCS, is highly interesting and warrants further investigation in high quality RCTs. Trial registration: www.clinicaltrials.gov. Trial registration number: NCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505. Graphical abstract *Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers) **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71. For more information, visit: http://www.prisma-statement.org/

show abstract

A study protocol for an ongoing multi-arm, randomized, double-blind, sham-controlled clinical trial with digital features, using portable transcranial electrical stimulation and internet-based behavioral therapy for major depression disorders: The PSYLECT study

Cited by 5 publications

References 56 publications

Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode

Home-Use Transcranial Direct Current Stimulation for the Treatment of a Major Depressive Episode

Transcranial Direct Current Stimulation as Treatment for Major Depression in a Home Treatment Setting (HomeDC Trial): Study Design and Methodology of a Double-blind, Placebo-controlled Pilotstudy

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

Contact Info

Product

Resources

About