産後うつ病と幼児の感情調節のためのCBT
産後うつ病の治療が乳児の感情調節に与える影響
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Ontario
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Hamilton、Ontario、カナダ、L8S 4L8
- McMaster University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
説明
包含基準:
- 18歳以上の女性
- 英語を理解し、話す(CBTグループに参加し、学習対策を完了することができるようにするため)
- オンタリオ州に住んでいます (主要な WHCC 流域)
- EPDSスコアが10以上
- 併存する精神疾患の診断基準を満たしています。
- 乳幼児は、登録時に生後 4 ~ 8 か月である必要があります。
除外基準:
- 双極性障害
- 現在の精神障害
- 物質またはアルコール使用障害
- 反社会性または境界性パーソナリティ障害。
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし:コントロール(通常通りの治療)
対照群は、産科医、助産師、および/または家庭医から標準的な産後ケアを受けます
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実験的:治療(9週間のオンラインCBTグループ)
治療グループに割り当てられた参加者は、すでに受けている可能性のある医療(例:
かかりつけ医、助産師、産婦人科医など)を対象に、訓練を受けた心理学者、ソーシャルワーカー、看護師、精神科医 2 名が Zoom 経由で実施する、産後うつ病(PPD)に対する 9 週間のグループ認知行動療法(CBT)介入に参加します。 。
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産後うつ病 (PPD) に対する 9 週間のグループ認知行動療法 (CBT) 介入は、2 人の訓練を受けた心理学者によって Zoom を介して提供されます。
この介入は、St. Joseph's Healthcare Hamilton の Women's Health Concerns Clinic (WHCC) の Dr. Van Lieshout (主任研究者) によって開発されました。
簡潔でシンプルで、地域社会の女性に適用できるように設計されています。
週 9 回の 2 時間のセッションで構成され、コア CBT スキルを毎週学び、実践します。
各セッションの前半は、認知再構築を含むコア CBT コンテンツに専念します。
後半は、PPD を持つ母親に関連するトピック (睡眠、サポート、役割の移行など) について、参加者が共同で主導するグループ ディスカッションに専念します。
宿題は各セッションで割り当てられます。
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Infant Temperament
時間枠: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
時間枠: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
時間枠: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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Brain-to-brain Synchrony (fNIRS)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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NEO-FFI: the NEO Five-Factor Inventory
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Ryan Van Lieshout, MD, PHD、Mcmaster
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。