RCT of At-Home tDCS for Depression in Pregnancy

Status Recruiting

Clinical Trial Summary

This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum

Clinical Trial Description

Transcranial direct current stimulation (tDCS) is a brain stimulation technique for the treatment of depression that has great potential for filling the gap in treatment options for moderate and severe depression in pregnancy. Participants are randomized 1:1 to active tDCS treatment or sham control. After at least one in-person training session with the research team, participants take the tDCS device home and self-administer 30-minute treatments 5 times per week, for 3 weeks, for a total of 15 sessions. Rater-administered and self-report outcomes are collected weekly during the 3-week active treatment phase, every 4 weeks during pregnancy, and at 4-, 12-, 26- and 52-weeks postpartum. A mixed methods process evaluation is embedded into the trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05097586
Study type	Interventional
Source	Women's College Hospital
Contact	Simoe Vigod
Phone	4163236400
Email	simone.vigod@wchospital.ca
Status	Recruiting
Phase	N/A
Start date	November 8, 2021
Completion date	June 2027

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