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

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

经颅电刺激（Transcranial electrical stimulation，tES）被认为对抑郁症具有一定疗效与安全性，尽管效果较为温和，且在外部医疗机构开展时存在较高的后勤实施负担。针对便携式经颅电刺激（portable tES，ptES）的相关研究，以及联合远程心理干预强化ptES效果的方案，已展现出积极但仍属初步的研究结果。本研究报告一项正在进行的具备数字化特性的多臂、随机、双盲、假对照临床试验的研究依据与试验设计，该试验针对重度抑郁症（major depressive disorder，MDD）采用ptES联合基于互联网的行为疗法（internet-based behavioral therapy，iBT），临床试验编号为NCT04889976。

本研究将评估三种干预方案在基线汉密尔顿抑郁量表17项版（Hamilton Depression Rating Scale – 17 item version，HDRS-17）评分≥17的成年MDD患者中，为期6周干预后的疗效、安全性、耐受性与可用性：（1）活性ptES+活性iBT（“双活性组”）；（2）活性ptES+假对照iBT（“仅ptES组”）；（3）假对照ptES+假对照iBT（“双假对照组”）。试验期间允许患者维持稳定剂量的抗抑郁药物治疗。

我们的主要共同假设有三：其一，“双活性组”的HDRS-17评分改善幅度优于“仅ptES组”；其二，“双活性组”的HDRS-17评分改善幅度优于“双假对照组”；其三，“仅ptES组”的HDRS-17评分改善幅度优于“双假对照组”。本研究计划招募210名受试者（每组70例）。本研究结果有望为数字化心理健康领域中，联合ptES与iBT治疗MDD的疗效与可扩展性提供全新的研究视角。