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Group CBT for PPD in the Public Health Setting

Impact of Public Health Nurse Delivered Group CBT for Postpartum Depression on Women and Their Children: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03039530
Enrollment
141
Registered
2017-02-01
Start date
2017-04-01
Completion date
2021-01-01
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Postpartum

Keywords

Postpartum Depression, Cognitive Behavioral Therapy, Public Health, Mother, Infant, Emotion

Brief summary

Postpartum depression (PPD) affects over 14,000 women in Ontario each year and can have profound effects on mothers, their children, and their families. The cost of one case of PPD exceeds $150,000, a significant proportion of which is related to its impact on offspring. However, difficulties accessing preferred treatments (e.g., psychotherapy) result in fewer than 15% of women receiving care. While Public Health Units have played an important role in PPD detection in Ontario, Public Health Nurses (PHNs) currently lack the skills to deliver evidence-based treatment to women. Cognitive Behavioural Therapy (CBT) delivered in group format is effective for treating depression in the perinatal period, and as PHNs are often the first point of contact for women experiencing PPD, with specialized training it is likely that they can deliver high-quality CBT. The primary objective of this study is to determine if PHNs can be trained to deliver group Cognitive Behavioral Therapy (CBT) to acutely treat PPD, reduce relapse and recurrence, improve mother-infant attachment and parenting and optimize infant emotional functioning.

Detailed description

In addition to its effects on maternal health, PPD can adversely affect mother-infant attachment, parenting, and the development and health of her children. The negative effects of PPD on offspring can include an increased risk of insecure attachment, poorer cognitive, language, and behavioral development, as well as an increased risk of emotion regulatory problems. To determine if PHNs can effectively deliver group CBT for PPD that is superior to postnatal care as usual, the investigators will proceed with a randomized controlled trial (RCT). Women in the treatment group will attend a 9-week group CBT intervention delivered by trained PHNs. Those in the control group will receive standard postnatal care. This RCT will compare the effects of group CBT to postnatal care as usual on maternal depression, anxiety, mother-infant attachment, parenting, healthcare utilization and social support, as well as infant development, emotion regulation, and healthcare utilization

Interventions

9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.

Postnatal care as usual will involve treatment from their family physician and midwife or obstetrician, and voluntary participation in programs offered by Niagara Region Public Health and in the community.

Sponsors

Niagara Region Public Health
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Eligible women will be \>18 years of age, understand and speak English (so that they can participate in the CBT group and complete study measures), have an EPDS score between 10 and 23. They will also all be within 12 months of delivering an infant

Exclusion criteria

* Women can have psychiatric comorbidities with the exception of bipolar disorder, a current psychotic, substance or alcohol use disorder, or antisocial or borderline personality disorder.

Design outcomes

Primary

MeasureTime frameDescription
Edinburgh Postnatal Depression Scale (EPDS)6 monthsThe EPDS will be used to assess maternal depression. A score of \>12 is consistent with PPD and changes in scores \>4 are indicative of clinically significant improvement.
Mini International Neuropsychiatric Interview - Current Major Depressive Disorder6 monthsUsed to assess maternal depression.

Secondary

MeasureTime frameDescription
Penn State Worry Questionnaire (PSWQ)6 monthsMaternal Anxiety will be assessed using the Penn State Worry Questionnaire.
Postpartum Bonding Questionnaire6 monthsUsed to detect disorders of the mother-infant relationship.
Parent-Child Early Relational Assessment6 monthsUsed to measure the quality of affect and behavior in parent-child interactions.
Social Provisions Scale6 monthsUsed to measure the degree to which mothers' social relationships provide support
Parasympathetic Nervous System Functioning: Heart Rate Variability6 monthsUsed to asses the flexibility of the central and peripheral nervous system to handle stress.
Maternal & Infant Healthcare Utilization6 monthsAdopted form the Canadian Community Health Survey to track use of healthcare services.
Infant Behaviour Questionnaire-Revised6 monthsThis scale assesses infant temperament
Face-to-Face Still Face Paradigm6 monthsExperimental task used to assess emotion regulation in infants
Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)6 monthsCorticolimbic brain activity at the scalp will be assessed using electroencephalography (EEG). Greater left frontal asymmetry (greater activity in the left frontal hemisphere) is thought to reflect positive emotionality and indicate a greater tendency to engage in more adaptive emotion regulation strategies. However greater right activity reflects a tendency to engage in withdrawn behaviours and negative emotionality.
Ages and Stages Questionnaires - Third Edition6 monthsAssesses infant communication, motor and socioemotional development using age-specific scales.
Salivary Cortisol6 monthsUsed to assess stress reactivity and emotion regulation. Three samples will be taken during each assessment: 10-15 minutes after the beginning of the assessment, 15-20 minutes after the face-to-face still face task and at the end of the visit.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026