- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05269732
산후우울증과 영아 정서조절을 위한 CBT
산후 우울증 치료가 영아 감정 조절에 미치는 영향
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8S 4L8
- McMaster University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 18세 이상의 여성
- 영어 이해 및 말하기 (CBT 그룹 참여 및 학습 측정 완료)
- 온타리오(주요 WHCC 집수 지역)에 거주
- EPDS 점수가 10 이상이어야 합니다.
- 동반이환 정신과적 상태에 대한 진단 기준을 충족합니다.
- 유아는 등록 시점에 4-8개월 사이여야 합니다.
제외 기준:
- 양극성 장애
- 현재의 정신병적 장애
- 물질 또는 알코올 사용 장애
- 반사회적 또는 경계선 성격 장애.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어(평소와 같이 처리)
대조군은 산부인과 의사, 조산사 및/또는 가정의로부터 표준 산후 관리를 받습니다.
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실험적: 치료(9주 온라인 CBT 그룹)
치료 그룹에 배정된 참가자는 이미 받고 있는 모든 의료 서비스(예:
가정의, 조산사, 산부인과 전문의 등) 및 두 명의 숙련된 심리학자, 사회 복지사, 간호사 및/또는 정신과 의사가 Zoom을 통해 제공하는 산후 우울증(PPD)에 대한 9주 그룹 인지 행동 치료(CBT) 개입에 참여합니다. .
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산후 우울증(PPD)에 대한 9주간의 그룹 인지 행동 치료(CBT) 중재는 숙련된 심리학자 2명이 Zoom을 통해 제공했습니다.
이 중재는 St. Joseph's Healthcare Hamilton에 있는 Women's Health Concerns Clinic(WHCC)의 Dr. Van Lieshout(수석 연구원)에 의해 개발되었습니다.
간단하고 간단하며 지역 사회 환경의 여성에게 적용할 수 있도록 설계되었습니다.
매주 9개의 2시간 세션으로 구성되어 있으며 매주 핵심 CBT 기술을 배우고 연습합니다.
각 세션의 전반부는 인지 재구성을 포함한 핵심 CBT 콘텐츠에 할애됩니다.
후반부는 PPD가 있는 어머니와 관련된 주제(예: 수면, 지원, 역할 전환)에 대해 참가자가 공동으로 진행하는 그룹 토론에 할애됩니다.
숙제는 각 세션에서 할당됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Infant Temperament
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Brain-to-brain Synchrony (fNIRS)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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NEO-FFI: the NEO Five-Factor Inventory
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Ryan Van Lieshout, MD, PHD, Mcmaster
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .