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CBT til postpartum depression og spædbørns følelsesregulering

13. juli 2026 opdateret af: McMaster University

Indvirkningen af ​​behandling af postpartum depression på spædbørns følelsesregulering

Det primære formål med denne undersøgelse er at afgøre, om online gruppe kognitiv adfærdsterapi (CBT) for moder postpartum depression (PPD) tilføjet til behandling som sædvanlig (TAU) fører til større forbedringer i spædbørns følelsesregulering (ER) end moderens modtagelse af TAU alene umiddelbart efter behandlingen og 6 måneder senere. Denne undersøgelse vil også sigte mod at bestemme, hvilke mekanismer PPD-behandling fører til ændringer i spædbørns ER.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Et prospektivt, enkeltblindt, parallelt randomiseret kontrolleret forsøg (1:1-forhold), der inkluderer en eksperimentel (modtagelse af en 9-ugers gruppe CBT-intervention leveret online plus TAU) og kontrolgruppe (TAU alene) for at opfylde vores mål. Deltagerne vil have en EPDS-score på 10 eller mere og et spædbarn i alderen 4-8 måneder og blive rekrutteret fra fællesskabet. Eksperimentgruppen vil modtage en valideret 9-ugers online gruppe kognitiv adfærdsterapi (CBT) intervention på Zoom plus TAU. Kontrolgruppen vil modtage TAU alene. I begge grupper vil TAU bestå af regelmæssige planlagte besøg hos deres psykiatriske kliniker sammen med eventuelle andre interventioner, der skønnes nødvendige. Forsøgsinterventionen består af ni, 2-timers sessioner, der finder sted en gang om ugen. Den første halvdel af hver session er afsat til CBT-kerneindhold, herunder kognitiv omstrukturering. Anden halvdel er afsat til gruppediskussioner ledet af deltagere om emner, der er relevante for mødre med PPD (f.eks. søvn, støtte, rolleovergange). Grupper vil blive leveret af to uddannede psykologer, socialrådgivere, sygeplejersker og/eller psykiatere. Primært mål: Bestem, om online gruppe kognitiv adfærdsterapi (CBT) for maternal PPD tilføjet til behandling som sædvanlig (TAU) fører til større forbedringer i spædbørns ER end moderens modtagelse af TAU alene umiddelbart efter behandling og 6 måneder senere. Sekundært mål: Bestem de formodede mekanismer, hvorigennem PPD-behandling fører til ændringer i spædbarns ER.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

172

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • McMaster University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år til 95 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • kvinder 18 år eller ældre
  • forstå og tale engelsk (så de kan deltage i CBT-gruppen og gennemføre undersøgelsesforanstaltninger)
  • bor i Ontario (det primære WHCC-opland)
  • har en EPDS-score på 10 eller mere
  • opfylder diagnostiske kriterier for komorbide psykiatriske tilstande.
  • Spædbørn skal være mellem 4-8 måneder gamle ved tilmelding.

Ekskluderingskriterier:

  • maniodepressiv
  • en aktuel psykotisk lidelse
  • stof- eller alkoholmisbrug
  • antisocial eller borderline personlighedsforstyrrelse.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrol (behandling som sædvanlig)
Kontrolgruppen vil modtage standard postnatal pleje fra deres fødselslæge, jordemoder og/eller familielæge
Eksperimentel: Behandling (9 ugers online CBT gruppe)
Deltagere, der er tildelt behandlingsgruppen, vil fortsat modtage enhver sundhedspleje, de måske allerede modtager (f. familielæge, jordemoder, fødselslæge/gynækolog osv.) og deltage i en 9-ugers gruppe kognitiv adfærdsterapi (CBT) intervention for postpartum depression (PPD) leveret via Zoom af to uddannede psykologer, socialrådgivere, sygeplejersker og/eller psykiatere .
Adfærdsmæssigt: Gruppekognitiv adfærdsterapi (CBT)
Den 9-ugers gruppe kognitiv adfærdsterapi (CBT) intervention for postpartum depression (PPD) leveret via Zoom af to uddannede psykologer. Denne intervention blev udviklet af Dr. Van Lieshout (Principal Investigator) ved Women's Health Concerns Clinic (WHCC) ved St. Joseph's Healthcare Hamilton. Den er designet til at være kort, enkel og anvendelig for kvinder i samfundsmiljøer. Den består af 9 ugentlige 2-timers sessioner, hvor centrale CBT-færdigheder læres og øves hver uge. Den første halvdel af hver session er afsat til CBT-kerneindhold, herunder kognitiv omstrukturering. Anden halvdel er afsat til gruppediskussioner ledet af deltagere om emner, der er relevante for mødre med PPD (f.eks. søvn, støtte, rolleovergange). Der tildeles lektier ved hver session.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Infant Temperament
Tidsramme: 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.
Enrollment, 9 weeks and 6 months
Infant emotion regulation
Tidsramme: 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.
Enrollment, 9 weeks and 6 months
Maternal Depression
Tidsramme: 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.
Enrollment, 9 weeks, 6 and 30 months later
Maternal Anxiety
Tidsramme: 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.
Enrollment, 9 weeks, 6 and 30 months later

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Brain-to-brain Synchrony (fNIRS)
Tidsramme: Enrollment, 9 weeks and 6 months
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.
Enrollment, 9 weeks and 6 months
The Face-to-Face Stillage Paradigm (FFSP)
Tidsramme: Enrollment, 9 weeks and 6 months
The Face-to-Face Stillage Paradigm (FFSP) will be used to observe infant emotion regulatory patterns.
Enrollment, 9 weeks and 6 months
Parent-Child Early Relational Assessment (PCERA)
Tidsramme: Enrollment, 9 weeks and 6 months
Parent-Child Early Relational Assessment (PCERA) will be used to observe infant emotion regulatory patterns.
Enrollment, 9 weeks and 6 months
Epigenetic Analyses
Tidsramme: Enrollment, 9 weeks and 6 and 30 months later
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.
Enrollment, 9 weeks and 6 and 30 months later
mPFC Activity (Dense-array functional near-infrared spectroscopy)
Tidsramme: 30 months post T3
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.
30 months post T3
Corticolimbic Brain Activity: Electroencephalographic (EEG) Frontal Alpha Asymmetry (FAA)
Tidsramme: 30 months post T3
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.
30 months post T3
PSNS Activity: High-frequency Heart Rate Variability (HF-HRV)
Tidsramme: 30 months post T3
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.
30 months post T3
Dyadic regulation of frustration
Tidsramme: 30 months post T3
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.
30 months post T3
Frustration and flexible attention regulation
Tidsramme: 30 months post T3
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).
30 months post T3
Higher-order flexibility capacity
Tidsramme: 30 months post T3
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.
30 months post T3
Child Temperament
Tidsramme: 30 months post T3
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.
30 months post T3
Irritability Behaviours
Tidsramme: 30 months post T3
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.
30 months post T3
Child Emotion Regulation
Tidsramme: 30 months post T3
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.
30 months post T3
Mechanisms underlying changes to infant ER
Tidsramme: 30 months post T3

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
Maternal Emotion Regulation
Tidsramme: 30 months post T3
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.
30 months post T3
Diagnostic Assessment Research Tool
Tidsramme: 30 months post T3
The DART will be used to determine probable diagnosis of MDD and GAD.
30 months post T3

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
NEO-FFI: the NEO Five-Factor Inventory
Tidsramme: 30 months post T3
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.
30 months post T3
Maternal Mood Variability
Tidsramme: 30 months post T4
Maternal Mood Variability: Questionnaire of unpredictability in childhood-brief-QUIC-5 will be used to capture unpredictable experiences in the mother's own childhood.
30 months post T4
Maternal Sleep
Tidsramme: 30 months post T3
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.
30 months post T3
Maternal Sleep Quality
Tidsramme: 30 months post T3
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.
30 months post T3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

McMaster University

Efterforskere

  • Ledende efterforsker: Ryan Van Lieshout, MD, PHD, Mcmaster

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juni 2022

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

15. februar 2022

Først indsendt, der opfyldte QC-kriterier

25. februar 2022

Først opslået (Faktiske)

8. marts 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PIER CBT

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Ingen

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