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Completed

NCT Number: NCT03039530

Group CBT for PPD in the Public Health Setting

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.

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Key information

Conditions

Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Niagara Region Public Health

Thorold, Ontario, L2V 4Y6, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Group Cognitive Behavioral Therapy

Behavioral

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

Postnatal care as usual

Behavioral

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.

Primary outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: 6 months

    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.

  2. Mini International Neuropsychiatric Interview - Current Major Depressive Disorder

    Time frame: 6 months

    Used to assess maternal depression.

Secondary outcomes

  1. Penn State Worry Questionnaire (PSWQ)

    Time frame: 6 months

    Maternal Anxiety will be assessed using the Penn State Worry Questionnaire.

  2. Postpartum Bonding Questionnaire

    Time frame: 6 months

    Used to detect disorders of the mother-infant relationship.

  3. Parent-Child Early Relational Assessment

    Time frame: 6 months

    Used to measure the quality of affect and behavior in parent-child interactions.

  4. Social Provisions Scale

    Time frame: 6 months

    Used to measure the degree to which mothers' social relationships provide support

  5. Ages and Stages Questionnaires - Third Edition

    Time frame: 6 months

    Assesses infant communication, motor and socioemotional development using age-specific scales.

  6. Maternal & Infant Healthcare Utilization

    Time frame: 6 months

    Adopted form the Canadian Community Health Survey to track use of healthcare services.

  7. Infant Behaviour Questionnaire-Revised

    Time frame: 6 months

    This scale assesses infant temperament

  8. Face-to-Face Still Face Paradigm

    Time frame: 6 months

    Experimental task used to assess emotion regulation in infants

  9. Parasympathetic Nervous System Functioning: Heart Rate Variability

    Time frame: 6 months

    Used to asses the flexibility of the central and peripheral nervous system to handle stress.

  10. Salivary Cortisol

    Time frame: 6 months

    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.

  11. Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Niagara Region Public Health

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2017
Registry last updated
Apr 19, 2021

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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