Clinical trial NCT05097586: 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
Overall status: RECRUITING
Phase: NA
Conditions: Major Depression
Pregnancy
Postpartum Depression
Keywords: Pregnancy
Depression
Transcranial direct current stimulation
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
name: Sunnybrook Health Sciences Centre
First posted: 2021-10-28
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms post treatment
timeFrame: End of Week 3 of treatment
Secondary outcomes:
measure: Remission of depression
timeFrame: 4 weeks postpartum
measure: Depressive symptoms
timeFrame: End of Week 1, and Week 2 of treatment, q4 weeks during pregnancy, and 4-, 12-, 26- and 52-weeks postpartum
measure: Self-reported depressive symptoms
timeFrame: 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)
measure: Self-reported anxiety symptoms
timeFrame: 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)
measure: Maternal Quality of Life (QoL)
timeFrame: 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)
measure: Health Service Use: Health System Costs
timeFrame: 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)
measure: Health Service Use: Productivity Loss
timeFrame: 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)
measure: Health Service Use: Participant Cost
timeFrame: 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)
measure: Dyadic Relationship
timeFrame: 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)
measure: Maternal Birth Outcomes
timeFrame: 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)
measure: Neonatal Birth Outcomes
timeFrame: 4 weeks postpartum (up to 32 weeks)
measure: Maternal Child Relationship
timeFrame: 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
measure: Infant Temperament
timeFrame: 12 and 52 weeks postpartum (up to 80 weeks)
measure: Child Development
timeFrame: 12 and 52 weeks postpartum (up to 80 weeks)
Other outcomes:
measure: Concurrent Health Service Use
timeFrame: 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)
measure: Tolerability of Intervention
timeFrame: End of Week 1, Week 2 and Week 3 of treatment
measure: Stanford Expectancy Scale
timeFrame: Baseline
measure: Integrity of Treatment Blindness Questionnaire
timeFrame: End of session 1, End of Week 3 of treatment
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Sophie Grigoriadis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Daniel Blumberger, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Simone Vigod, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: