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NCT Number: NCT05097586

RCT of At-Home 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

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depression, Postpartum Depressive Disorder Depressive Disorder, Major Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Depression Pregnancy Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active tDCS

Device

2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks

Workbook

Other

Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state

Sham tDCS

Device

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 outcomes

  1. 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. 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 outcomes

  1. 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. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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)

  12. 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

  13. 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

  14. 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

Other outcomes

  1. 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

  2. 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

  3. Stanford Expectancy Scale

    Time frame: Baseline

    Assesses participant expectations of treatment effectiveness

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Simoe Vigod

CONTACT

[email protected]

4163236400 ext. 4080

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • Centre for Addiction and Mental Health
  • Sunnybrook Health Sciences Centre

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Oct 28, 2021
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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