- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05097586
RCT of At-Home tDCS for Depression in Pregnancy
April 22, 2024 updated by: Simone Vigod, Women's College Hospital
Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
156
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Simoe Vigod
- Phone Number: 4080 4163236400
- Email: simone.vigod@wchospital.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Not yet recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Sophie Grigoriadis, MD
- Phone Number: 416-480-5677
- Email: sophie.grigoriadis@sunnybrook.ca
-
Principal Investigator:
- Sophie Grigoriadis, MD
-
Toronto, Ontario, Canada, M5S1B2
- Recruiting
- Women's College Hospital
-
Contact:
- Simone Vigod, MD
- Phone Number: 4080 4163236400
- Email: simone.vigod@wchospital.ca
-
Principal Investigator:
- Simone Vigod
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- Adult, ≥18 years of age
- Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization
- 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)
- 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
- 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:
- Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS
- Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Bipolar disorder as assessed by MINI International Neuropsychiatric Interview
- Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview
- 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
- Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI/Co-I assessment)
- Metal implants in cranium or any electrical implants
- Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS
- Visibly non-intact skin/rash on scalp areas at stimulation electrode sites
- Unable to consent or complete study measures in English, or unable to complete depression in pregnancy workbook (the attention-control) in French or English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: active tDCS
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.
|
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 Comparator: control
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive symptoms post treatment
Time Frame: 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
|
End of Week 3 of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remission of depression
Time Frame: 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
|
4 weeks postpartum
|
Depressive symptoms
Time Frame: 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.
|
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
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)
|
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
|
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
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)
|
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
|
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)
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)
|
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
|
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
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)
|
Calculated from participant self-report of medical costs such as hospitalization, visits with health professionals and medications
|
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
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)
|
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
|
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
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)
|
Calculated from participant self-report of costs related to attending appointments and obtaining services
|
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
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)
|
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
|
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
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)
|
Self-reported pregnancy and birth complications querying indicators recommended by the Canadian Perinatal Surveillance System (CPSS)
|
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
Time Frame: 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)
|
4 weeks postpartum (up to 32 weeks)
|
Maternal Child Relationship
Time Frame: 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
|
4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
|
Infant Temperament
Time Frame: 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
|
12 and 52 weeks postpartum (up to 80 weeks)
|
Child Development
Time Frame: 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
|
12 and 52 weeks postpartum (up to 80 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concurrent Health Service Use
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 concurrent mental health service use such as psychotherapy or antidepressant use that could confound treatment
|
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)
|
Tolerability of Intervention
Time Frame: End of Week 1, Week 2 and Week 3 of treatment
|
Assessed using the rater-administered Toronto Side Effects Scale which is an anti-depressant side effects scale
|
End of Week 1, Week 2 and Week 3 of treatment
|
Stanford Expectancy Scale
Time Frame: Baseline
|
Assesses participant expectations of treatment effectiveness
|
Baseline
|
Integrity of Treatment Blindness Questionnaire
Time Frame: End of session 1, End of Week 3 of treatment
|
Participants report whether they believe they have received the treatment or the sham control.
|
End of session 1, End of Week 3 of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sophie Grigoriadis, MD, PhD, Sunnybrook Health Sciences Centre
- Principal Investigator: Daniel Blumberger, MD, MSc, Centre for Addiction and Mental Health
- Principal Investigator: Simone Vigod, MD, MSc, Women's College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2021
Primary Completion (Estimated)
January 31, 2026
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
October 1, 2021
First Submitted That Met QC Criteria
October 27, 2021
First Posted (Actual)
October 28, 2021
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTO Project ID: 3263
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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