产后抑郁症和婴儿情绪调节的 CBT
治疗产后抑郁症对婴儿情绪调节的影响
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Hamilton、Ontario、加拿大、L8S 4L8
- McMaster University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 18 岁或以上的女性
- 理解和说英语(以便他们可以参加 CBT 小组并完成学习措施)
- 住在安大略省(主要 WHCC 集水区)
- EPDS 得分为 10 分或以上
- 符合合并精神疾病的诊断标准。
- 婴儿在入学时必须年满 4-8 个月。
排除标准:
- 躁郁症
- 当前的精神障碍
- 物质或酒精使用障碍
- 反社会或边缘型人格障碍。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:对照(照常治疗)
对照组将接受产科医生、助产士和/或家庭医生的标准产后护理
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实验性的:治疗(9周在线CBT组)
分配到治疗组的参与者将继续接受他们可能已经接受的任何医疗保健(例如,
家庭医生、助产士、妇产科医生等),并参加由两名训练有素的心理学家、社会工作者、护士和/或精神科医生通过 Zoom 提供的为期 9 周的针对产后抑郁症 (PPD) 的集体认知行为疗法 (CBT) 干预。
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由两名训练有素的心理学家通过 Zoom 提供为期 9 周的针对产后抑郁症 (PPD) 的团体认知行为疗法 (CBT) 干预。
该干预措施由圣约瑟夫医疗保健中心汉密尔顿妇女健康问题诊所 (WHCC) 的 Van Lieshout 博士(首席研究员)开发。
它旨在简明扼要,适用于社区环境中的女性。
它包括每周 9 节 2 小时的课程,每周学习和练习核心 CBT 技能。
每节课的前半部分专门介绍核心 CBT 内容,包括认知重构。
下半场由参与者共同主持小组讨论,讨论与 PPD 母亲相关的话题(例如,睡眠、支持、角色转换)。
每节课都会布置家庭作业。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Infant Temperament
大体时间:Enrollment, 9 weeks and 6 months
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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.
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Enrollment, 9 weeks and 6 months
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Infant emotion regulation
大体时间:Enrollment, 9 weeks and 6 months
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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.
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Enrollment, 9 weeks and 6 months
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Maternal Depression
大体时间:Enrollment, 9 weeks, 6 and 30 months later
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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.
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Enrollment, 9 weeks, 6 and 30 months later
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Maternal Anxiety
大体时间:Enrollment, 9 weeks, 6 and 30 months later
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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.
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Enrollment, 9 weeks, 6 and 30 months later
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Brain-to-brain Synchrony (fNIRS)
大体时间:Enrollment, 9 weeks and 6 months
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Changes in Mother-Infant Synchrony: Physiological and behavioural synchrony patterns are thought to shape infant ER development and explain how treating PPD may exert its effects on infants.
Brain-to-brain Synchrony (fNIRS): The fNIRS pre-scanning technique will be used.
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Enrollment, 9 weeks and 6 months
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The Face-to-Face Stillage Paradigm (FFSP)
大体时间:Enrollment, 9 weeks and 6 months
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The Face-to-Face Stillage Paradigm (FFSP) will be used to observe infant emotion regulatory patterns.
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Enrollment, 9 weeks and 6 months
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Parent-Child Early Relational Assessment (PCERA)
大体时间:Enrollment, 9 weeks and 6 months
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Parent-Child Early Relational Assessment (PCERA) will be used to observe infant emotion regulatory patterns.
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Enrollment, 9 weeks and 6 months
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Epigenetic Analyses
大体时间:Enrollment, 9 weeks and 6 and 30 months later
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One saliva sample will be taken from infants and from mothers at each study visit will be used for epigenetic analyses.
Epigenetic modifications will be used to mediate and assess the effect of early life interactions on development.
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Enrollment, 9 weeks and 6 and 30 months later
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mPFC Activity (Dense-array functional near-infrared spectroscopy)
大体时间:30 months post T3
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mPFC Activity (Dense-array functional near-infrared spectroscopy): Measures of oxy- and deoxygenated hemoglobin within the mPFC (medial section of Brodmann areas 9-12 and 25) will be assessed.
Hemodynamic activity generated specifically in the mPFC will be acquired using our Gowerlabs® dense array fNIRS system, which utilizes high density diffuse optical tomography (DOT) to produce 3-D images of targeted brain regions and functional connectivity.
High density-DOT fNIRS technology yields superior temporal and compatible spatial resolution to fMRI, but without needing to examine infants while sedated or asleep.
Adverse mPFC development is one of the most prominent mechanisms underlying later mental disorder risk.
Studies examining fNIRS test-retest and are robust to changes in head size.
In three pilot dyads, it demonstrated exceptional spatial specificity for infant mPFC activity.
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30 months post T3
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Corticolimbic Brain Activity: Electroencephalographic (EEG) Frontal Alpha Asymmetry (FAA)
大体时间:30 months post T3
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Corticolimbic Brain Activity: Electroencephalographic (EEG) Frontal Alpha Asymmetry (FAA).
Portable EEG headbands provide valid EEG activity assessments in adult and infant populations, and do not interfere with fNIRS caps/recordings.
These headbands will be used to examine asymmetric patterns of EEG activity over the frontal lobes.
These patterns reflect the activity of multiple corticolimbic brain areas underlying affective tendencies and regulatory capacity, including the prefrontal cortex, amygdala, hippocampus, anterior cingulate and insula.
Greater relative right FAA in infancy reflects a predisposition to negative emotions and difficulties regulating them, is considered a marker of psychopathology vulnerability and is linked to increased risk for depression and anxiety across the lifespan.
Measures of FAA are stable across infancy and into childhood.
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30 months post T3
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PSNS Activity: High-frequency Heart Rate Variability (HF-HRV)
大体时间:30 months post T3
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PSNS Activity: High-frequency Heart Rate Variability (HF-HRV).
HF-HRV, obtained by the Mindware LTD electrocardiogram (ECG), reflects greater flexibility of the PSNS to handle stress and enables infants to utilize social interactions to regulate physiological states.
HRV is linked to the integrated activity of multiple brain regions, including the mPFC and amygdala.
HRV is an index of coordinated activity in top-down regulatory brain regions and sub-cortical emotion generation networks that serve to guide flexible, adaptive control of behaviour.
Low HRV in infancy is among the earliest emerging markers of poor ER and is linked to risk for depression, anxiety and even physical health problems in adulthood.
HF-HRV shows robust test-retest reliability across infancy.
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30 months post T3
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Dyadic regulation of frustration
大体时间:30 months post T3
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Parent-Child Play Task: Birthing parents and their child will be given a 3D puzzle comprised of 7 wooden pieces of different lengths and colours (Castle Logix, Smart Games).
The puzzle can be solved in different ways based on a guidebook.
Parents will be given the guidebook and asked to instruct the child (using only their words) to design two versions of the puzzle.
This task aims to challenge the dyad through a problem solving situation, and assesses dyadic regulation of frustration.
The dyad will play with this activity for 5 minutes.
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30 months post T3
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Frustration and flexible attention regulation
大体时间:30 months post T3
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Tower of Patience task: This task will be used to measure frustration and flexible attention regulation.
The child and the tester (research assistant) will work together to build a tower out of blocks.
They will take turns placing blocks on top of one another.
Each time it is the tester's turn to place a block, they will delay their turn by intervals of 10 seconds (i.e., wait 10 seconds to place block one, wait 20 seconds to place block two, wait 30 seconds to place block three, and so on until 8 blocks have been placed or 4 turns have passed).
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30 months post T3
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Higher-order flexibility capacity
大体时间:30 months post T3
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Pet-Store Stroop Task: Using a touch screen computer, children are tasked with putting animals which had escaped from a pet store back into their cages (bring a dog back to the other dogs).
In control conditions, animals are identified by both their appearance and sound (a dog will bark).
However, in conditions designed to assess neurobehavioural flexibility, animals will utter the sound of a different species (a dog will say "meow")- and children are required to sort the animal based on the sound, not appearance.
This task is sensitive to early emerging higher-order flexibility capacity (shifting attention between competing demands) and activates the PFC brain regions that appear to be affected by exposure to PPD, and that underly ER2.
The task takes approximately 5 minutes to complete.
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30 months post T3
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Child Temperament
大体时间:30 months post T3
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Child behavior Questionnaire Very Short Form (CBQ-VSF): Birthing parents will complete the 36-item CBQ-VSF, which captures three broad dimensions of child temperament, each of which contribute to ER capacity.
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30 months post T3
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Irritability Behaviours
大体时间:30 months post T3
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Multidimensional Assessment Profile Temper Loss (MAPS-TL) Scale: Children's mothers will complete the 22-item Temper Loss Scale of the MAP, which uses a Likert-Type Scale (never=0, many times per day=6) to assess the intensity and duration of key irritability behaviours, including mood and tantrums (e.g., "gets quite frustrated when prevented from doing something s/he wants to do").
Importantly, this scale is specifically designed to decipher between typical and atypical levels of irritability in early childhood.
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30 months post T3
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Child Emotion Regulation
大体时间:30 months post T3
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Child Behavior Questionnaire (CBCL 1.5-5):
The CBCL is a validated, well recognized scale which measures multiple problem behaviours associated with poor ER capacity.
Birthing parents will complete this 99-item scale to assess these potential problem behaviours in their child4.
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30 months post T3
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Mechanisms underlying changes to infant ER
大体时间:30 months post T3
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Changes in Mother-Infant Synchrony Brain-to-brain Synchrony (fNIRS): We will use fNIRS hyperscanning techniques to target synchronized right dorsolateral (Brodmann's area 9 and 46) and frontopolar activity (Brodmann's area 10) of the PFC within dyads. Frontal EEG Asymmetry Synchrony PSNS Synchrony Behavioural Synchrony will be quantified by examining the duration of mismatched emotions and behaviours within dyads during the FFSP paradigm during the free play task at T4. Maternal Regulatory Parenting: At T4, regulatory parenting (appropriate limit setting, resourcefulness) will be examined using the coding interactive behaviour (CIB) scale during the free play task |
30 months post T3
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Maternal Emotion Regulation
大体时间:30 months post T3
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Maternal Emotion Regulation: At T4, the Difficulties in Emotion Regulation Scale (DERS) will be used to assess emotion regulation in mothers.
This is a 36-item self-report measure that assesses one's ability to understand, accept, and manage their emotions.
It assesses difficulties in six areas of emotion regulatory capacity in adults: non-acceptance of negative emotions, inability to engage in goal-directed behaviors when distressed, difficulties with impulse control, lack of awareness of emotional responses, limited access to regulation strategies, and difficulty understanding and clarifying.
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30 months post T3
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Diagnostic Assessment Research Tool
大体时间:30 months post T3
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The DART will be used to determine probable diagnosis of MDD and GAD.
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30 months post T3
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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NEO-FFI: the NEO Five-Factor Inventory
大体时间:30 months post T3
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NEO-FFI is a self-report questionnaire that assesses an individual's personality.
It is based on the five-factor model of personality (Openness to Experience, Conscientiousness, Extraversion, Agreeableness, and Neuroticism), and consists of 60 items.
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30 months post T3
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Maternal Mood Variability
大体时间:30 months post T4
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Maternal Mood Variability: Questionnaire of unpredictability in childhood-brief-QUIC-5 will be used to capture unpredictable experiences in the mother's own childhood.
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30 months post T4
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Maternal Sleep
大体时间:30 months post T3
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Maternal Sleep: Sleep disturbances are common during the peripartum, and have adverse effects on maternal mood, behaviour and mother-infant interactions.
Therefore, the Insomnia Symptom Questionnaire (ISQ) will be used to assess maternal insomnia symptoms, and overall sleep quality.
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30 months post T3
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Maternal Sleep Quality
大体时间:30 months post T3
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Maternal Sleep: Sleep disturbances are common during the peripartum, and have adverse effects on maternal mood, behaviour and mother-infant interactions.
Therefore, the Pittsburgh Sleep Quality Index (PSQI) will be used to assess maternal insomnia symptoms, and overall sleep quality.
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30 months post T3
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合作者和调查者
调查人员
- 首席研究员:Ryan Van Lieshout, MD, PHD、Mcmaster
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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