Major Depression, Postpartum Depression, Pregnancy
Conditions
Keywords
Pregnancy, Depression, Transcranial direct current stimulation
Brief 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
Detailed 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.
Interventions
DEVICEactive tDCS
2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks
OTHERworkbook
Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state
DEVICEsham tDCS
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
Sponsors
Women's College Hospital
Centre for Addiction and Mental Health
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult, ≥18 years of age 2. Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization 3. In a major depressive episode (MDE) with at least moderate symptom severity (PHQ-9 ≥10 and confirmed using MINI International Neuropsychiatric Interview as MDE without psychotic features) 4. Assessed by a psychiatrist at one of the study recruitment sites during pregnancy, and offered the option of antidepressant medication for treatment but declined to use 5. No new treatments for depression (i.e. psychological or somatic) and no pharmacological treatment for depression in the 4 weeks prior to starting treatment
Exclusion criteria
1. Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS 2. Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) 3. Bipolar disorder as assessed by MINI International Neuropsychiatric Interview 4. Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview 5. Major unstable or life-threatening medical illness (e.g. such as advanced cancer), pre-eclampsia/eclampsia in current pregnancy or neurologic illness or seizure history 6. Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI/Co-I assessment) 7. Metal implants in cranium or any electrical implants 8. Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS 9. Visibly non-intact skin/rash on scalp areas at stimulation electrode sites 10. Unable to consent or complete study measures in English, or unable to complete depression in pregnancy workbook (the attention-control) in French or English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms post treatment | End of Week 3 of 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. With 80% power, and a type 1 error rate of 0.05 we would require a sample size of 104 (52/group) to detect a statistically significant difference between tDCS and Sham on the primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission of depression | 4 weeks postpartum | 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. With 80% power, and a type 1 error rate of 0.05 we would require a sample size of 124 (62/group) to detect a statistically significant difference between tDCS and Sham on this main secondary outcome. |
| Depressive symptoms | End of Week 1, and Week 2 of treatment, q4 weeks during pregnancy, and 4-, 12-, 26- and 52-weeks postpartum | 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. |
| Self-reported depressive symptoms | 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) | 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 |
| Self-reported anxiety symptoms | 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) | 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 |
| Maternal Quality of Life (QoL) | 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) | 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 |
| Health Service Use: Health System Costs | 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) | Calculated from participant self-report of medical costs such as hospitalization, visits with health professionals and medications |
| Health Service Use: Productivity Loss | 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) | 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 |
| Health Service Use: Participant Cost | 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) | Calculated from participant self-report of costs related to attending appointments and obtaining services |
| Dyadic Relationship | 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) | 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 |
| Maternal Birth Outcomes | 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) | Self-reported pregnancy and birth complications querying indicators recommended by the Canadian Perinatal Surveillance System (CPSS) |
| Neonatal Birth Outcomes | 4 weeks postpartum (up to 32 weeks) | Self-reported neonatal birth outcomes including medical conditions and complications querying indicators recommended by the Canadian Perinatal Surveillance System (CPSS) |
| Maternal Child Relationship | 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks) | 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 |
| Infant Temperament | 12 and 52 weeks postpartum (up to 80 weeks) | 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 |
| Child Development | 12 and 52 weeks postpartum (up to 80 weeks) | Assessed using the Ages and Stages Questionnaire (ASQ-3), a 30-item instrument that screens for child development from 1 to 60 months |
Countries
Canada
Contacts
CONTACTSimone Vigod
PRINCIPAL_INVESTIGATORSophie Grigoriadis, MD, PhD
Sunnybrook Health Sciences Centre
PRINCIPAL_INVESTIGATORDaniel Blumberger, MD, MSc
Centre for Addiction and Mental Health
PRINCIPAL_INVESTIGATORSimone Vigod, MD, MSc
Women's College Hospital
Outcome results
None listed