Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Depressive symptoms post treatment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
active tDCS
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.
干预措施: active tDCS (Device)
active tDCS
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.
干预措施: workbook (Other)
control
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.
干预措施: workbook (Other)
control
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.
干预措施: sham tDCS (Device)
结局指标
主要结局
Depressive symptoms post treatment
时间窗: 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.
次要结局
- Remission of depression(4 weeks postpartum)
- Self-reported depressive symptoms(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(End of Week 1, and Week 2 of treatment, q4 weeks during pregnancy, and 4-, 12-, 26- and 52-weeks postpartum)
- Maternal Birth Outcomes(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(4 weeks postpartum (up to 32 weeks))
- Health Service Use: Participant Cost(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 Child Relationship(4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks))
- Child Development(12 and 52 weeks postpartum (up to 80 weeks))
- Self-reported anxiety symptoms(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(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(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))
- Infant Temperament(12 and 52 weeks postpartum (up to 80 weeks))
- Maternal Quality of Life (QoL)(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))
- Dyadic Relationship(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))
研究者
Simone Vigod
Principal Investigator, Professor of Psychiatry, Senior Scientist
Women's College Hospital