The portable transcranial electrical stimulation and internet-based behavioral therapy for major depression study (PSYLECT): results of the maintenance phase

Aparicio, Luana V.M.; Luethi, Matthias S.; Borrione, Lucas; Moran, Natasha K.S.; Cavendish, Beatriz A.; Silva, Valquiria A.; Valiengo, Leandro; Goerigk, Stephan; Padberg, Frank; Razza, Lais B.; Vidal, Kallene S.M.; Brunoni, Andre R.

doi:10.1016/j.jad.2025.120548

Cited by 1Transcranial Magnetic Stimulation StudiesTreatment of Major DepressionElectroconvulsive Therapy Studies

The portable transcranial electrical stimulation and internet-based behavioral therapy for major depression study (PSYLECT): results of the maintenance phase

Aparicio, Luana V.M., Luethi, Matthias S., Borrione, Lucas, Moran, Natasha K.S., Cavendish, Beatriz A., Silva, Valquiria A., Valiengo, Leandro, Goerigk, Stephan +4 more·2026·Journal of Affective Disorders

DOI 10.1016/j.jad.2025.120548

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Abstract

Background Transcranial direct current stimulation (tDCS) has demonstrated antidepressant efficacy, but optimal strategies for long-term maintenance remain unexplored. While clinic-based maintenance tDCS poses adherence and logistical challenges, home-based protocols may improve accessibility and prevent attrition.Objective To evaluate the efficacy and safety of home-based tDCS for relapse prevention in patients with major depressive disorder (MDD) during the maintenance phase of the PSYLECT trial.Methods Following the randomized controlled trial (Phase I, n = 210) and open-label crossover (Phase II), responders (≥50 % improvement in Hamilton Depression Rating Scale scores) were enrolled in Phase III: a 6-month, open-label continuation protocol involving twice-weekly home-based tDCS sessions (2 mA, 30 min, F3-F4 montage) with or without digital behavioral therapy (BT). The primary outcome was time to relapse, analyzed using Kaplan-Meier survival curves. Cox regression assessed predictors of relapse.Results Seventy-one patients (mean age 37.9 ± 9.0 years; 89 % female) were included in Phase III. At 24 weeks, 75 % (95 % CI, 64.2-82.8) remained without relapse or discontinuation, while survival without relapse alone was 82 %. Six participants (8.5 %) relapsed, and 11 (15.5 %) discontinued. No significant predictors of relapse were identified, nor did BT significantly enhance survivability. Adverse events were predominantly mild; most common were transient scalp itching (21 %) and headaches (18 %), while 40 % of participants reported no adverse events by month 6.Conclusion Home-based maintenance tDCS was safe, feasible, and led to clinically meaningful relapse prevention comparable to clinic-based protocols. Its advantages in terms of scalability, cost-effectiveness and accessibility support its potential as a maintenance strategy for MDD.

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13 of the 20 studies using scales use the Hamilton Depression Rating Scale, with varied score criteria: 8, 12, 14, 16, 18, and up to 20.
“13 of the 20 use the Hamilton Depression Rating Scale, although the score they establish as a criterion is very varied, with some considering a score of 8 points (4) as sufficient for a relapse, others of 12 (20), 14 (13, 14, 44), 16 (17, 18) 18 (47, 49) and up to 20 (9).”
From Administrative criteria in the relapse of depressive disorder: a critical appraisal (2026) · cites this paper as [44]

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Aparicio, L. V. M., Rosa, V. P., Razza, L. B., Sampaio-Júnior, B., Borrione, L., Valiengo, L. D. C. L., Lotufo, P. A., Benseñor, I. M., Fráguas, R., Moffa, A. H., et al. (2019) · Depression and Anxiety · doi:10.1002/da.22878 · Cited by 46 · see citing works
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Authors: Aparicio, L. V. M., Luethi, M. S., Borrione, L., Moran, N. K. S., Cavendish, B. A., Silva, V. A., Valiengo, L., Goerigk, S., Padberg, F., Razza, L. B., Vidal, K. S. M., & Brunoni, A. R.
Affiliations: Universidade de São Paulo (BR)
LMU Klinikum (DE)
ORCID: Aparicio, Luana V.M.
Luethi, Matthias S.
Borrione, Lucas
Cavendish, Beatriz A.
Valiengo, Leandro
Goerigk, Stephan
Vidal, Kallene S.M.
Venue: Journal of Affective Disorders
Publisher: Elsevier BV
Published: 2026-02
Volume: 394
Issue: Pt A
Pages: 120548
ISSN: 0165-0327 (ISSN-L)
DOI: 10.1016/j.jad.2025.120548
OpenAlex: W4415531779
Cited by: 1
References: 36
Citations by year: 2026: 1
FWCI: 0.36
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
doi.org/10.15223/policy-017 (stm-asf)
doi.org/10.15223/policy-037 (stm-asf)
doi.org/10.15223/policy-012 (stm-asf)
doi.org/10.15223/policy-029 (stm-asf)
doi.org/10.15223/policy-004 (stm-asf)
Locations: Journal of Affective Disorders (publishedVersion)
PubMed (publishedVersion)
Funders: State of Sao Paulo Research Foundation (2021/10574-0, 2019/06009-6)
Topics: Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
Keywords: transcranial direct current stimulation, home-based tDCS, major depressive disorder, relapse prevention, maintenance therapy, digital cognitive behavioral therapy, medication adherence, treatment safety, predictors of relapse
MeSH terms: Adult, Behavior Therapy, Combined Modality Therapy, Major Depressive Disorder, Female, Humans, Male, Middle Aged, Treatment Outcome, Cross-Over Studies, Internet, Secondary Prevention, Transcranial Direct Current Stimulation

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The portable transcranial electrical stimulation and internet-based behavioral therapy for major depression study (PSYLECT): results of the maintenance phase

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