Remotely supervised transcranial direct current stimulation

Postpartum Depression (PPD) is a Major Depressive Disorder (MDD) diagnosed within the first 12 months after delivery (7-9) with an estimated prevalence in Europe between 10-15% (10) and long-lasting negative effects to mothers and babies (11,12). Psychotherapy is the first line treatment for mild/moderate PPD, and Sertraline is suggested to severe cases. Although Psychotherapy is widely accepted, its efficacy is suboptimal (14-15], and is hardly scalable. Additionally, Sertraline is frequently prescribed regardless symptoms’ severity, but shows limited efficacy (50-67%), response by 6-8th week (14) and low acceptability rates (14,18,19). Transcranial Direct Current Stimulation (tDCS) has been suggested as an alternative (16-18) as it combines antidepressant efficacy (19), high tolerability and low risks (20-22), showing equivalency to pharmacotherapy (26) and faster response than psychotherapy (19). Clinic-based tDCS treatments intensiveness (with daily sessions for 3-6 weeks) led to the development of home-based tDCS solutions that have been successfully tested in MDD (28).

In my proposal I aim to extend current knowledge by adapting a remotely supervised tDCS intervention to the postpartum period (32). The intervention combines home-based tDCS, e-health for self-monitoring of mental health status and reading materials, a training program for self-delivered tDCS and a tele-health system to supervise and support selfapplication. During the first half of the research plan, I will assess the feasibility of the intervention in PPD (Study 1 application. During the first half of the research plan, I will assess the feasibility of the intervention in PPD (Study 1 [S1]) to determine a) the feasibility of the procedure, b) the feasibility of the outcomes assessment procedures and to c) estimate the parameters to inform the subsequent study. S1 will be crucial in the pathway towards Study 2 (S2), a randomized controlled trial to be conducted in the second half of the research plan. In S2, I will determine the effects of the intervention on PPD within a multicentre, parallel arm (active tDCS vs sham tDCS) randomized controlled design, using traditional mental health outcomes added by epigenetic and pro-inflammatory biomarkers, contributing to a precision-oriented approach in mental health. My proposal further tackles advances in cutting-edge home-based tDCS technology which is one of the vectors of innovation in non-invasive brain science. The adoption of e-health and tele-health solutions are novel mental health care strategies meant to promote self-management strategies and improve the engagement of patients.

Together, the project will widen women choices, and benefit women, babies and family’s mental health while reducing burden to health care systems. Ultimately, the project will progress the access barrier to high standard care that many women experience in the postpartum period due to their location and/or limited resources, towards the universal access to specialized perinatal mental health care.