- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03039530
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Thorold, Ontario, Canada, L2V 4Y6
- Niagara Region Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Group CBT for PPD.
Women in the treatment group will attend a 9-week group CBT intervention for PPD.
This intervention was developed 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, and a new psychoeducational topic is introduced and discussed by women each week.
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9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.
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Active Comparator: Control Group
Standard Care.
The usual care group will receive standard care from their family physician and midwife or obstetrician.
They will also be made aware of the perinatal programming available to them through Niagara Region Public Health.
Women and family physicians will also receive a copy of the Canadian Practice Guidelines for the Treatment of Perinatal Depression.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: 6 months
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The 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.
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6 months
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Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
Time Frame: 6 months
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Used to assess maternal depression.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postpartum Bonding Questionnaire
Time Frame: 6 months
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Used to detect disorders of the mother-infant relationship.
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6 months
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Penn State Worry Questionnaire (PSWQ)
Time Frame: 6 months
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Maternal Anxiety will be assessed using the Penn State Worry Questionnaire.
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6 months
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Parent-Child Early Relational Assessment
Time Frame: 6 months
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Used to measure the quality of affect and behavior in parent-child interactions.
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6 months
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Social Provisions Scale
Time Frame: 6 months
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Used to measure the degree to which mothers' social relationships provide support
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6 months
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Ages and Stages Questionnaires - Third Edition
Time Frame: 6 months
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Assesses infant communication, motor and socioemotional development using age-specific scales.
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6 months
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Maternal & Infant Healthcare Utilization
Time Frame: 6 months
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Adopted form the Canadian Community Health Survey to track use of healthcare services.
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6 months
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Infant Behaviour Questionnaire-Revised
Time Frame: 6 months
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This scale assesses infant temperament
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6 months
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Face-to-Face Still Face Paradigm
Time Frame: 6 months
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Experimental task used to assess emotion regulation in infants
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6 months
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Parasympathetic Nervous System Functioning: Heart Rate Variability
Time Frame: 6 months
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Used to asses the flexibility of the central and peripheral nervous system to handle stress.
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6 months
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Salivary Cortisol
Time Frame: 6 months
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Used 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.
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6 months
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Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)
Time Frame: 6 months
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Corticolimbic 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.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PH CBT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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