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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks
Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state
Sham stimulation in which the current turns off after 30 seconds in a slow ramp down that mirrors sensory adaptation in ongoing stimulation, delivered in 15 sessions lasting 30 minutes each over 3 weeks
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
NOT_YET_RECRUITINGWomen's College Hospital
Toronto, Ontario, Canada
RECRUITINGDepressive symptoms post treatment
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
Time frame: End of Week 3 of treatment
Remission of depression
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
Time frame: 4 weeks postpartum
Depressive symptoms
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.
Time frame: End of Week 1, and Week 2 of treatment, q4 weeks during pregnancy, and 4-, 12-, 26- and 52-weeks postpartum
Self-reported depressive 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
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Time frame: End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
Self-reported anxiety 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
Time frame: End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
Maternal Quality of Life (QoL)
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
Time frame: End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
Health Service Use: Health System Costs
Calculated from participant self-report of medical costs such as hospitalization, visits with health professionals and medications
Time frame: End of Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
Health Service Use: Productivity Loss
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
Time frame: End of Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
Health Service Use: Participant Cost
Calculated from participant self-report of costs related to attending appointments and obtaining services
Time frame: End of Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
Dyadic Relationship
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
Time frame: End of Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
Maternal Birth Outcomes
Self-reported pregnancy and birth complications querying indicators recommended by the Canadian Perinatal Surveillance System (CPSS)
Time frame: End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4 weeks postpartum (up to 32 weeks)
Neonatal Birth Outcomes
Self-reported neonatal birth outcomes including medical conditions and complications querying indicators recommended by the Canadian Perinatal Surveillance System (CPSS)
Time frame: 4 weeks postpartum (up to 32 weeks)
Maternal Child Relationship
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
Time frame: 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
Infant Temperament
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
Time frame: 12 and 52 weeks postpartum (up to 80 weeks)
Child Development
Assessed using the Ages and Stages Questionnaire (ASQ-3), a 30-item instrument that screens for child development from 1 to 60 months
Time frame: 12 and 52 weeks postpartum (up to 80 weeks)