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

ABSTRACT

Background

Transcranial electrical stimulation (tES) is considered effective and safe for depression, albeit modestly, and prone to logistical burdens when performed in external facilities. Investigation of portable tES (ptES), and potentiation of ptES with remote psychological interventions have shown positive, but preliminary, results.

Research design

We report the rationale and design of an ongoing multi-arm, randomized, double-blind, sham-controlled clinical trial with digital features, using ptES and internet-based behavioral therapy (iBT) for major depressive disorder (MDD) (NCT04889976).

Methods

We will evaluate the efficacy, safety, tolerability and usability of (1) active ptES + active iBT (‘double-active’), (2) active ptES + sham iBT (‘ptES-only’), and (3) sham ptES + sham iBT (‘double-sham’), in adults with MDD, with a Hamilton Depression Rating Scale – 17 item version (HDRS-17) score ≥ 17 at baseline, during 6 weeks. Antidepressants are allowed in stable doses during the trial.

Results

We primarily co-hypothesize changes in HDRS-17 will be greater in (1) ‘double-active’ compared to ‘ptES-only,’ (2) ‘double-active’ compared to ‘double-sham,’ and (3) ‘ptES-only’ compared to ‘double-sham.’ We aim to enroll 210 patients (70 per arm).

Conclusions

Our results should offer new insights regarding the efficacy and scalability of combined ptES and iBT for MDD, in digital mental health.

KEYWORDS:

• Digital mental health
• internet-based behavioral therapy
• major depressive disorder
• portable transcranial direct current stimulation
• portable transcranial electrical stimulation

Acknowledgments

We would like to express our special gratitude to the nurse practitioner, Ms. Valquiria Aparecida da Silva, and to the administrative official, Ms. Sandra Aparecida de Lima Falcon, for substantial logistical and operational support in PSYLECT.

Author contributions

LB, MSL, SG and ARB contributed to the conception and design of the paper. LB, MSL, SG and ARB performed the analysis and interpretation of the data. LB, PCC, BAC, MSL, BB, MV, ZD, IMB and ARB performed the initial drafting of the paper. All authors performed the critical revision of the paper. All authors agree to be accountable for all aspects of the work.

Declaration of interest

A R Brunoni receives scholarships and support from FAPESP, the Brazilian National Council of Scientific Development (CNPq CNPq-1B), University of São Paulo Medical School (FMUSP), the UK Academy of Medical Sciences (Newton Advanced Fellowship), and the International Health Cohort Consortium (IHCC). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed here

Additional information

Funding

The trial is sponsored by the public governmental agency FAPESP (São Paulo Research State Foundation) Thematic Grant (2019/06009 6). Flow NeuroscienceTM donated a small budget that was used solely for paying clinical and research staff directly involved in the trial. Flow NeuroscienceTM and FAPESP have no role in the study design, statistical analysis, and manuscript writing of any publication from PSYLECT.