Group CBT for PPD in the Public Health Setting

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03039530
Study type	Interventional
Source	McMaster University
Contact
Status	Completed
Phase	N/A
Start date	April 1, 2017
Completion date	January 1, 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.