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
NCT number | NCT03039530 |
Other study ID # | PH CBT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2017 |
Est. completion date | January 1, 2021 |
Verified date | April 2021 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Niagara Region Public Health | Thorold | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Niagara Region Public Health |
Canada,
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 |
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