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Postpartum DepressionNCT05269732

CBT for Postpartum Depression and Infant Emotion Regulation

A study testing Group Cognitive Behavioural Therapy (CBT) in people with Postpartum Depression, run by McMaster University at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Postpartum Depression
What is being tested?
Group Cognitive Behavioural Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteCanada
Study dates
17 Jun 2022to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McMaster University

    Hamilton, Ontario, L8S 4L8

Other trials in Canada

About this study

Official title: The Impact of Treating Postpartum Depression on 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.

Read the detailed description

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.

Being tested
Group Cognitive Behavioural Therapy (CBT)
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Cognitive Behavioural Therapy (CBT)Behavioural

    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.

Study groups in NCT05269732
Study groupRoleWhat they receive
Treatment (9-week online CBT group)ExperimentalParticipants assigned to the treatment group will continue to receive any healthcare they might already be receiving (e.g. family doctor, midwife, Obstetrician/Gynecologist, etc.) and participate in a 9-week group Cognitive Behavioral Therapy (CBT) intervention for Postpartum Depression (PPD) delivered via Zoom by two trained psychologists, social workers, nurses, and/or psychiatrists.
Receives: Behavioral: Group Cognitive Behavioural Therapy (CBT)
Control (treatment as usual)No interventionThe control group will receive standard postnatal care from their obstetrician, midwife, and/or family physician

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infant Temperament

    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.

    Measured: Enrollment, 9 weeks and 6 months

  2. Infant emotion regulation

    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.

    Measured: Enrollment, 9 weeks and 6 months

  3. Maternal Depression

    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.

    Measured: Enrollment, 9 weeks, 6 and 30 months later

  4. Maternal Anxiety

    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.

    Measured: Enrollment, 9 weeks, 6 and 30 months later

Secondary outcomes (16)
  1. Brain-to-brain Synchrony (fNIRS)

    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.

    Measured: Enrollment, 9 weeks and 6 months

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

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

    Measured: Enrollment, 9 weeks and 6 months

  3. Parent-Child Early Relational Assessment (PCERA)

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

    Measured: Enrollment, 9 weeks and 6 months

  4. Epigenetic Analyses

    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.

    Measured: Enrollment, 9 weeks and 6 and 30 months later

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

    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.

    Measured: 30 months post T3

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

    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.

    Measured: 30 months post T3

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

    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.

    Measured: 30 months post T3

  8. Dyadic regulation of frustration

    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.

    Measured: 30 months post T3

  9. Frustration and flexible attention regulation

    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).

    Measured: 30 months post T3

  10. Higher-order flexibility capacity

    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.

    Measured: 30 months post T3

  11. Child Temperament

    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.

    Measured: 30 months post T3

  12. Irritability Behaviours

    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.

    Measured: 30 months post T3

  13. Child Emotion Regulation

    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.

    Measured: 30 months post T3

  14. Mechanisms underlying changes to infant ER

    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

    Measured: 30 months post T3

  15. Maternal Emotion Regulation

    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.

    Measured: 30 months post T3

  16. Diagnostic Assessment Research Tool

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

    Measured: 30 months post T3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2022
  2. Study start17 Jun 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to the treatment group (delivered group CBT plus TAU) or the control group (treatment as usual).
Masking
Single blind
Who is masked
Investigator
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05269732
Sponsor's protocol ID
PIER CBT
Status last verified
Jan 2026
First submitted
15 Feb 2022
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group Cognitive Behavioural Therapy (CBT) in people with Postpartum Depression, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant Temperament (time frame: Enrollment, 9 weeks and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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