RCT of At-Home tDCS for Depression in Pregnancy

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Depressive symptoms post treatment [Срок оценки: End of Week 3 of treatment]

Вторичные конечные точки (12)

• Remission of depression [Срок оценки: 4 weeks postpartum]
• Depressive symptoms [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 4 weeks postpartum (up to 32 weeks)]
• Maternal Child Relationship [Срок оценки: 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

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

Идентификаторы

NCT: NCT05097586 · CTO Project ID: 3263

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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