Back to resultsRCT of At-Home tDCS for Depression in Pregnancy
Primary Purpose
Major Depression, Pregnancy, Postpartum Depression
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
active tDCS
workbook
sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring Pregnancy, Depression, Transcranial direct current stimulation
Eligibility Criteria
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
Sites / Locations
- Sunnybrook Health Sciences Centre
- Women's College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
active tDCS
control
Arm Description
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.
Outcomes
Primary Outcome Measures
Depressive 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
Secondary Outcome Measures
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
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.
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
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
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
Health Service Use: Health System Costs
Calculated from participant self-report of medical costs such as hospitalization, visits with health professionals and medications
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
Health Service Use: Participant Cost
Calculated from participant self-report of costs related to attending appointments and obtaining services
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
Maternal Birth Outcomes
Self-reported pregnancy and birth complications querying indicators recommended by the Canadian Perinatal Surveillance System (CPSS)
Neonatal Birth Outcomes
Self-reported neonatal birth outcomes including medical conditions and complications querying indicators recommended by the Canadian Perinatal Surveillance System (CPSS)
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
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
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
Full Information
NCT ID
NCT05097586
First Posted
October 1, 2021
Last Updated
April 24, 2023
Sponsor
Women's College Hospital
Collaborators
Centre for Addiction and Mental Health, Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT05097586
Brief Title
RCT of At-Home tDCS for Depression in Pregnancy
Official Title
Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women's College Hospital
Collaborators
Centre for Addiction and Mental Health, Sunnybrook Health Sciences Centre
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Pregnancy, Postpartum Depression
Keywords
Pregnancy, Depression, Transcranial direct current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks
Intervention Type
Other
Intervention Name(s)
workbook
Intervention Description
Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
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
Primary Outcome Measure Information:
Title
Depressive symptoms post treatment
Description
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
Secondary Outcome Measure Information:
Title
Remission of depression
Description
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
Title
Depressive symptoms
Description
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
Title
Self-reported depressive symptoms
Description
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
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)
Title
Self-reported anxiety symptoms
Description
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)
Title
Maternal Quality of Life (QoL)
Description
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)
Title
Health Service Use: Health System Costs
Description
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)
Title
Health Service Use: Productivity Loss
Description
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)
Title
Health Service Use: Participant Cost
Description
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)
Title
Dyadic Relationship
Description
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)
Title
Maternal Birth Outcomes
Description
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)
Title
Neonatal Birth Outcomes
Description
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)
Title
Maternal Child Relationship
Description
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)
Title
Infant Temperament
Description
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)
Title
Child Development
Description
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)
Other Pre-specified Outcome Measures:
Title
Concurrent Health Service Use
Description
Self-reported concurrent mental health service use such as psychotherapy or antidepressant use that could confound treatment
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)
Title
Tolerability of Intervention
Description
Assessed using the rater-administered Toronto Side Effects Scale which is an anti-depressant side effects scale
Time Frame
End of Week 1, Week 2 and Week 3 of treatment
Title
Stanford Expectancy Scale
Description
Assesses participant expectations of treatment effectiveness
Time Frame
Baseline
Title
Integrity of Treatment Blindness Questionnaire
Description
Participants report whether they believe they have received the treatment or the sham control.
Time Frame
End of session 1, End of Week 3 of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simoe Vigod
Phone
4163236400
Ext
4080
Email
simone.vigod@wchospital.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Grigoriadis, MD, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Blumberger, MD, MSc
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simone Vigod, MD, MSc
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Grigoriadis, MD
Phone
416-480-5677
Email
sophie.grigoriadis@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Sophie Grigoriadis, MD
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S1B2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Vigod, MD
Phone
4163236400
Ext
4080
Email
simone.vigod@wchospital.ca
First Name & Middle Initial & Last Name & Degree
Simone Vigod
12. IPD Sharing Statement
Learn more about this trial
RCT of At-Home tDCS for Depression in Pregnancy
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