The Impact of Treating Postpartum Depression on Infant Emotion Regulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Infant Temperament
研究概览
简要总结
The primary objective of this study is to determine if online group cognitive behavioral therapy (CBT) for maternal postpartum depression (PPD) added to treatment as usual (TAU) leads to greater improvements in infant emotion regulation (ER) than maternal receipt of TAU alone immediately post-treatment, 6 and 30 months later. This study will also aim to determine what mechanisms PPD treatment leads to changes in infant ER.
详细描述
A prospective, single-blind, parallel randomized controlled trial (1:1 ratio) that includes an experimental (receipt of a 9-week group CBT intervention delivered online plus TAU) and control group (TAU alone) to address our objectives. Participants will have an EPDS score of 10 or more and an infant 3-12 months of age and be recruited from the community. The experimental group will receive a validated 9-week online group cognitive behavioral therapy (CBT) intervention on Zoom plus TAU. The control group will receive TAU alone. In both groups, TAU will consist of regular care from their family doctor, midwife, OB/GYN an/or any other types of care they may be accessing. The trial intervention consists of nine, 2-hour sessions occurring once per week. The first half of each session is devoted to core CBT content, including cognitive restructuring. The second half is devoted to group discussions co-led by participants on topics relevant to mothers with PPD (e.g., sleep, supports, role transitions). Groups will be delivered by two trained psychologists, social workers, nurses, and/or psychiatrists. Primary objective: Determine if online group cognitive behavioural therapy (CBT) for maternal PPD added to treatment as usual (TAU) lead to greater improvements in infant ER than maternal receipt of TAU alone immediately post-treatment, 6 months and 30 months later. Secondary objective: Determine the putative mechanisms through which PPD treatment leads to changes in infant ER.
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
- Single (Investigator)
盲法说明
The principal investigator, outcome assessors and data analysts will be blinded to participant allocation.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 18 years of age or older
- •understand and speak English (so that they can participate in the CBT group and complete study measures)
- •live in Ontario (the primary WHCC catchment area)
- •have an EPDS score of 10 or more
- •meets diagnostic criteria for comorbid psychiatric conditions.
- •Infants must be between 4-12 months old at enrollment.
排除标准
- •bipolar disorder
- •a current psychotic disorder
- •substance or alcohol use disorder
- •antisocial or borderline personality disorder.
研究组 & 干预措施
Treatment (9-week online CBT group)
Participants assigned to the treatment group will continue to receive any healthcare they might already be receiving (e.g. family doctor, midwife, Obstetrician/Gynecologist, etc.) and participate in a 9-week group Cognitive Behavioral Therapy (CBT) intervention for Postpartum Depression (PPD) delivered via Zoom by two trained psychologists, social workers, nurses, and/or psychiatrists.
干预措施: Group Cognitive Behavioural Therapy (CBT) (Behavioral)
Control (treatment as usual)
The control group will receive standard postnatal care from their obstetrician, midwife, and/or family physician
结局指标
主要结局
Infant Temperament
时间窗: 6 months
Infant Behavior Questionnaire-Revised (IBQ-R): The IBQ-R is a 91-item scale with 14 subscales that measure infant temperament. Temperament refers to the ways individuals think, behave, and react and is heavily influenced by the degree to which infants and toddlers can regulate their emotions. The items on the IBQ ask parents to rate the frequency of specific temperament-related behaviors observed over the past week. Items are scored on a scale of 0-7. Mothers will complete the IBQ-R on their infants immediately before treatment, right after treatment, and at 6 months afterward.
Infant emotion regulation
时间窗: 6 months
Emotional Regulation (ER) is comprised of biological and behavioural domains best measured with validated physiological, observational and informant reports that assess this phenomenon across the full range of infant functioning. Physiological measures: Medial Pre-frontal complex (mPFC) activity using functional near-infrared spectroscopy will be used to observe infant emotion regulatory patterns.
Maternal Depression
时间窗: 6 months
Edinburgh Postnatal Depression Scale (EPDS): The EPDS is the 10-item gold standard measure of maternal depressive symptoms. Scores range from 0-30, with higher scores indicating worse depressive symptoms. Mothers will complete the EPDS immediately before treatment, right after treatment, and at 6 months afterward.
Maternal Anxiety
时间窗: 6 months
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a self-report scale that taps generalized anxiety disorder, the most common comorbidity of Postpartum Depression (PPD). Scores range from 0-21 with higher scores indicating worse anxiety symptoms. Mothers will complete the GAD-7 immediately before treatment, right after treatment, and at 6 months afterward.
Infant Temperament
时间窗: Enrollment, 9 weeks and 6 months
Infant Behavior Questionnaire-Revised (IBQ-R): The IBQ-R is a 91-item scale with 14 subscales that measure infant temperament. Temperament refers to the ways individuals think, behave, and react and is heavily influenced by the degree to which infants and toddlers can regulate their emotions. The items on the IBQ ask parents to rate the frequency of specific temperament-related behaviors observed over the past week. Items are scored on a scale of 0-7. Mothers will complete the IBQ-R on their infants immediately before treatment, right after treatment (9 weeks), and at 6 months afterward.
Infant emotion regulation
时间窗: Enrollment, 9 weeks and 6 months
Emotional Regulation (ER) is comprised of biological and behavioural domains best measured with validated physiological, observational and informant reports that assess this phenomenon across the full range of infant functioning. Physiological measures: Medial Pre-frontal complex (mPFC) activity using functional near-infrared spectroscopy will be used to observe infant emotion regulatory patterns.
Maternal Depression
时间窗: Enrollment, 9 weeks, 6 and 30 months later
Edinburgh Postnatal Depression Scale (EPDS): The EPDS is the 10-item gold standard measure of maternal depressive symptoms. Scores range from 0-30, with higher scores indicating worse depressive symptoms. Mothers will complete the EPDS immediately before treatment, right after treatment, and at 6 months afterward.
Maternal Anxiety
时间窗: Enrollment, 9 weeks, 6 and 30 months later
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a self-report scale that taps generalized anxiety disorder, the most common comorbidity of Postpartum Depression (PPD). Scores range from 0-21 with higher scores indicating worse anxiety symptoms. Mothers will complete the GAD-7 immediately before treatment, right after treatment, and at 6 months afterward.
次要结局
- Brain-to-brain Synchrony (fNIRS)(6 months)
- The Face-to-Face Stillage Paradigm (FFSP)(6 months)
- Parent-Child Early Relational Assessment (PCERA)(6 months)
- Epigenetic Analyses(6 months)
- Brain-to-brain Synchrony (fNIRS)(Enrollment, 9 weeks and 6 months)
- The Face-to-Face Stillage Paradigm (FFSP)(Enrollment, 9 weeks and 6 months)
- Parent-Child Early Relational Assessment (PCERA)(Enrollment, 9 weeks and 6 months)
- Epigenetic Analyses(Enrollment, 9 weeks and 6 and 30 months later)
- mPFC Activity (Dense-array functional near-infrared spectroscopy)(30 months post T3)
- Corticolimbic Brain Activity: Electroencephalographic (EEG) Frontal Alpha Asymmetry (FAA)(30 months post T3)
- PSNS Activity: High-frequency Heart Rate Variability (HF-HRV)(30 months post T3)
- Dyadic regulation of frustration(30 months post T3)
- Frustration and flexible attention regulation(30 months post T3)
- Higher-order flexibility capacity(30 months post T3)
- Child Temperament(30 months post T3)
- Diagnostic Assessment Research Tool(30 months post T3)
- Irritability Behaviours(30 months post T3)
- Child Emotion Regulation(30 months post T3)
- Mechanisms underlying changes to infant ER(30 months post T3)
- Maternal Emotion Regulation(30 months post T3)