Clinical trial NCT03039530: Group CBT for PPD in the Public Health Setting
Official title: Impact of Public Health Nurse Delivered Group CBT for Postpartum Depression on Women and Their Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Keywords: Postpartum Depression
Cognitive Behavioral Therapy
Public Health
Mother
Infant
Emotion
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Niagara Region Public Health
First posted: 2017-02-01
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 6 months
measure: Mini International Neuropsychiatric Interview - Current Major Depressive Disorder
timeFrame: 6 months
Secondary outcomes:
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: 6 months
measure: Postpartum Bonding Questionnaire
timeFrame: 6 months
measure: Parent-Child Early Relational Assessment
timeFrame: 6 months
measure: Social Provisions Scale
timeFrame: 6 months
measure: Ages and Stages Questionnaires - Third Edition
timeFrame: 6 months
measure: Maternal & Infant Healthcare Utilization
timeFrame: 6 months
measure: Infant Behaviour Questionnaire-Revised
timeFrame: 6 months
measure: Face-to-Face Still Face Paradigm
timeFrame: 6 months
measure: Parasympathetic Nervous System Functioning: Heart Rate Variability
timeFrame: 6 months
measure: Salivary Cortisol
timeFrame: 6 months
measure: Corticolimbic Brain Function: EEG-Based Frontal Lobe Asymmetry (via MUSE Headband)
timeFrame: 6 months
Other outcomes:
Locations:
city: Thorold
country: Canada
facility: Niagara Region Public Health
state: Ontario
Study officials:
References:
citation: Van Lieshout RJ, Layton H, Savoy CD, Haber E, Feller A, Biscaro A, Bieling PJ, Ferro MA. Public Health Nurse-delivered Group Cognitive Behavioural Therapy for Postpartum Depression: A Randomized Controlled Trial. Can J Psychiatry. 2022 Jun;67(6):432-440. doi: 10.1177/07067437221074426. Epub 2022 Jan 21.