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

RCT of At-Home tDCS for Depression in Pregnancy

Major Depression

Pregnancy

Postpartum Depression

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.

active tDCS

workbook

sham tDCS

Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy

Depressive symptoms are measured with the 10-item rater-administered Montgomery Asberg
Depression Rating Scale (MADRS).The MADRS is a standard rater-administered measure with
good reliability and validity in clinical populations; interviewers can achieve and
maintain high levels of inter-rater reliability. Nine items are based upon patient report
and one on rater observation. Items are rated on a 0-6 continuum (0=no abnormality,
6=severe; score range 0-60). A MADRS score of <11 indicates remission

Principal Investigator, Professor of Psychiatry, Senior Scientist

Measured with the 10-item rater-administered Montgomery Asberg Depression Rating Scale
(MADRS).The MADRS is a standard rater-administered measure with good reliability and
validity in clinical populations; interviewers can achieve and maintain high levels of
inter-rater reliability. Nine items are based upon patient report and one on rater
observation. Items are rated on a 0-6 continuum (0=no abnormality, 6=severe; score range
0-60). A MADRS score of <11 indicates remission

measured with the 10-item rater-administered Montgomery Asberg Depression Rating Scale
(MADRS).The MADRS is a standard rater-administered measure with good reliability and
validity in clinical populations; interviewers can achieve and maintain high levels of
inter-rater reliability. Nine items are based upon patient report and one on rater
observation. Items are rated on a 0-6 continuum (0=no abnormality, 6=severe; score range
0-60). A lower score indicates less severe symptoms.

Depressive symptoms will be measured using the Edinburgh Postnatal Depressive Scale
(EPDS), a self-report scale that has been validated for use in pregnancy and postpartum.
EPDS scores range from 0 to 30. EPDS scores >12 are predictive of a diagnosis of
depression, with higher scores indicating more severe symptoms

Measured using the Generalized Anxiety Disorder-7 (GAD-7) scale which is a self-report
scale with good discriminate validity in perinatal populations. GAD-7 scores range from 0
to 21, with higher scores indicating more severe symptoms

Measured using 12-Item Short Form Survey (SF-12), a 12-item measure often used to
estimate quality-adjusted life year (QALY), a preference-based utility measure of
health-related QoL as perceived by the patient and the gold standard measure of
effectiveness recommended for economic evaluation. SF12 scores consist of Physical and
Mental Component Summaries. Scores range from 0-100 with higher scores indicating better
functioning

Calculated from participant self-report of medical costs such as hospitalization, visits
with health professionals and medications

Calculated from participant self-report of activities and time commitment related to
attending appointments and obtaining services, work absences of the patient and family
members

Calculated from participant self-report of costs related to attending appointments and
obtaining services

Relationship satisfaction measured using the Dyadic Consensus Subscale, a 13-item
subscale of the 32-item Dyadic Adjustment Scale (DAS). This self-report measure of the
extent of agreement between partners is valid for measuring overall dyadic adjustment.
Higher scores indicate a higher degree of dyadic consensus

Self-reported pregnancy and birth complications querying indicators recommended by the
Canadian Perinatal Surveillance System (CPSS)

Self-reported neonatal birth outcomes including medical conditions and complications
querying indicators recommended by the Canadian Perinatal Surveillance System (CPSS)

Parenting stress is measured by the Parenting Stress Index Short Form (PSI-SF) which is a
36-item measure consisting of 6 sub-scales: parental distress, dysfunction in the
parent-child relations and difficult child. Scores range from 36 to 180. Higher scores
indicate higher levels of parenting stress

Measured using the Infant Characteristics Questionnaire (ICQ). The ICQ is a 27-item
questionnaire with each item coded 1-7. Higher scores indicate higher parental
perceptions of difficult infant temperament

Assessed using the Ages and Stages Questionnaire (ASQ-3), a 30-item instrument that
screens for child development from 1 to 60 months

2mA of direct current delivered to the dorsolateral prefrontal cortex for 30 minutes
each, 5 times per week for 3 weeks, for a total of 15 sessions using the Soterix Medical
tDCS mini-CT model 1601-LTE.

Sham stimulation where the current is turned off after 30 seconds in a slow ramp down,
delivered to the dorsolateral prefrontal cortex for 30 minutes each, 5 times per week for
3 weeks, for a total of 15 sessions using the Soterix Medical tDCS mini-CT model
1601-LTE.

RCT of At-Home tDCS for Depression in Pregnancy

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status