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

Overview

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

• Device active tDCS
  2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks
• Other workbook
  Self-directed depression in pregnancy workbook completed during each session to control the in-session brain state
• Device sham 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

Primary outcome measures

• Depressive symptoms post treatment [Time frame: End of Week 3 of treatment]

Secondary outcome measures (12)

• Remission of depression [Time frame: 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]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• Neonatal Birth Outcomes [Time frame: 4 weeks postpartum (up to 32 weeks)]
• Maternal Child Relationship [Time frame: 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Canada · 2 centers

• Sunnybrook Health Sciences Centre — Toronto
• Women's College Hospital — Toronto

Identifiers

NCT: NCT05097586 · CTO Project ID: 3263

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗