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Active, Not Recruiting

NCT Number: NCT05269732

CBT for Postpartum Depression and Infant Emotion Regulation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • bipolar disorder
  • a current psychotic disorder
  • substance or alcohol use disorder
  • antisocial or borderline personality disorder.

Treatment and study plan

Group Cognitive Behavioural Therapy (CBT)

Behavioral

The 9-week group Cognitive Behavioural Therapy (CBT) intervention for Postpartum Depression (PPD) delivered via Zoom by two trained psychologists. This intervention was developed by Dr. Van Lieshout (Principal Investigator) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced each 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). Homework is assigned at each session.

Primary outcomes

  1. Infant Temperament

    Time frame: 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.

  2. Infant emotion regulation

    Time frame: 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.

  3. Maternal Depression

    Time frame: 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.

  4. Maternal Anxiety

    Time frame: 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.

Secondary outcomes

  1. Brain-to-brain Synchrony (fNIRS)

    Time frame: 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.

  2. The Face-to-Face Stillage Paradigm (FFSP)

    Time frame: Enrollment, 9 weeks and 6 months

    The Face-to-Face Stillage Paradigm (FFSP) will be used to observe infant emotion regulatory patterns.

  3. Parent-Child Early Relational Assessment (PCERA)

    Time frame: Enrollment, 9 weeks and 6 months

    Parent-Child Early Relational Assessment (PCERA) will be used to observe infant emotion regulatory patterns.

  4. Epigenetic Analyses

    Time frame: 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.

  5. mPFC Activity (Dense-array functional near-infrared spectroscopy)

    Time frame: 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.

  6. Corticolimbic Brain Activity: Electroencephalographic (EEG) Frontal Alpha Asymmetry (FAA)

    Time frame: 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.

  7. PSNS Activity: High-frequency Heart Rate Variability (HF-HRV)

    Time frame: 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.

  8. Dyadic regulation of frustration

    Time frame: 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.

  9. Frustration and flexible attention regulation

    Time frame: 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).

  10. Higher-order flexibility capacity

    Time frame: 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.

  11. Child Temperament

    Time frame: 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.

  12. Irritability Behaviours

    Time frame: 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.

  13. Child Emotion Regulation

    Time frame: 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.

  14. Mechanisms underlying changes to infant ER

    Time frame: 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

  15. Maternal Emotion Regulation

    Time frame: 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.

  16. Diagnostic Assessment Research Tool

    Time frame: 30 months post T3

    The DART will be used to determine probable diagnosis of MDD and GAD.

Other outcomes

  1. NEO-FFI: the NEO Five-Factor Inventory

    Time frame: 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.

  2. Maternal Mood Variability

    Time frame: 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.

  3. Maternal Sleep

    Time frame: 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.

  4. Maternal Sleep Quality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

The Impact of Treating Postpartum Depression on Infant Emotion Regulation

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2022
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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