Group CBT for PPD in the Public Health Setting

Depression, Postpartum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039530
• Other study ID #: PH CBT
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Behavioral:
• Group Cognitive Behavioral Therapy
9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.
• Postnatal Care As Usual
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.

Locations

Country	Name	City	State
Canada	Niagara Region Public Health	Thorold	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Niagara Region Public Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edinburgh Postnatal Depression Scale (EPDS)	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.	6 months
Primary	Mini International Neuropsychiatric Interview - Current Major Depressive Disorder	Used to assess maternal depression.	6 months
Secondary	Penn State Worry Questionnaire (PSWQ)	Maternal Anxiety will be assessed using the Penn State Worry Questionnaire.	6 months
Secondary	Postpartum Bonding Questionnaire	Used to detect disorders of the mother-infant relationship.	6 months
Secondary	Parent-Child Early Relational Assessment	Used to measure the quality of affect and behavior in parent-child interactions.	6 months
Secondary	Social Provisions Scale	Used to measure the degree to which mothers' social relationships provide support	6 months
Secondary	Ages and Stages Questionnaires - Third Edition	Assesses infant communication, motor and socioemotional development using age-specific scales.	6 months
Secondary	Maternal & Infant Healthcare Utilization	Adopted form the Canadian Community Health Survey to track use of healthcare services.	6 months
Secondary	Infant Behaviour Questionnaire-Revised	This scale assesses infant temperament	6 months
Secondary	Face-to-Face Still Face Paradigm	Experimental task used to assess emotion regulation in infants	6 months
Secondary	Parasympathetic Nervous System Functioning: Heart Rate Variability	Used to asses the flexibility of the central and peripheral nervous system to handle stress.	6 months
Secondary	Salivary Cortisol	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.	6 months
Secondary	Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)	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.	6 months