Public Health Nurse-Peer Co-Led Group Cognitive Behavioral Therapy for Postpartum Depression
NCT ID: NCT06597448
Last Updated: 2025-12-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
170 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-09-16
Study Completion Date
2028-01-01
Brief Summary
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The purpose of this study is to determine the effectiveness of an online 9-week group Cognitive Behavioural Therapy (CBT; a type of talking therapy) intervention that is co-led by public health nurses (PHNs) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (PPD) for treating PPD when delivered in addition to treatment as usual (TAU) compared to TAU alone. The study will also assess the impact of the intervention on common comorbidities (anxiety) and complications (parenting stress, mother-infant relationship, social support, and infant temperament) of PPD and whether it is cost-effective.
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Detailed Description
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The primary objective of the Randomized Controlled Trial (RCT) is to determine if a 9-week group Cognitive Behavioral Therapy (CBT) intervention delivered online and co-led by public health nurses (PHNs) and peers added to treatment as usual (TAU) can improve postpartum depression (PPD) more than TAU alone. Peers are individuals who have previously recovered from PPD and received training to deliver the intervention. The secondary objective of the RCT is to determine if the intervention can effectively treat its common comorbidities (anxiety) and complications (parenting stress, social support, mother-infant relationship, and infant temperament) and whether the intervention is cost-effective. 170 mothers/birthing parents will take part in the study with 50% being randomly assigned to the intervention group. All participants complete online questionnaires at 3 time points: baseline (T1), 9 weeks later (T2-immediately post-intervention in the experimental group to assess effectiveness) and 6 months later (T3-intervention durability).
Conditions
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Postpartum Depression
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants who have met the eligibility requirements and signed the consent form are randomized and allocated in a 1:1 ratio to one of two groups: Intervention (those who participate in the 9-week CBT group along with treatment as usual) and Control (continue with treatment as usual alone). Control group participants receive a list of mental health resources. Both groups complete online questionnaires at 3 timepoints: enrollment (T1), 9 weeks later (T2-post intervention for those in the intervention group) and 6 months later (T3).
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Data analysts will be blinded. Data is deidentified and a study ID number is assigned. Research assistants following up with T2 and T3 questionnaires and phone interviews will be blinded.
Study Groups
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Online CBT Group
Participants randomized to the Intervention group will attend a 9-week online CBT group co-led by a Public Health Nurse and a Peer (individual who has recovered from PPD and received training to deliver the intervention) in addition to receiving usual care.
Group Type
EXPERIMENTAL
Cognitive Behavioral Therapy for Postpartum Depression (PPD)
Intervention Type
BEHAVIORAL
Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The intervention consists of 9- 2hr sessions, the first half involves teaching and practice of CBT skills (cognitive restructuring, thinking errors, problem solving etc) followed by one hour of unstructured discussion around topics relevant to participants with Postpartum Depression (PPD) (sleep, supports, transitions, etc). Each group will be delivered by one randomly selected PHN and one randomly selected peer using our intervention manual.
Treatment as Usual
Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Cognitive Behavioral Therapy for Postpartum Depression (PPD)
Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The intervention consists of 9- 2hr sessions, the first half involves teaching and practice of CBT skills (cognitive restructuring, thinking errors, problem solving etc) followed by one hour of unstructured discussion around topics relevant to participants with Postpartum Depression (PPD) (sleep, supports, transitions, etc). Each group will be delivered by one randomly selected PHN and one randomly selected peer using our intervention manual.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
Mothers or birthing parents, 18 years old, have an infant under 12 months of age at recruitment, fluent in written/spoken English, have a Edinburgh Postnatal Depression Scale (EPDS) score ≥10 and live in Ontario, Canada.
Exclusion Criteria
Bipolar, psychotic, or current substance use disorders and borderline personality disorder as assessed during screening when study coordinator administers the Mini International Neuropsychiatric Interview (MINI).
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Niagara Region Public Health
OTHER
Sponsor Role
collaborator
McMaster University
OTHER
Sponsor Role
lead
Responsible Party
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Ryan Van Lieshout, MD, PhD
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ryan J Van Lieshout, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University
Hamilton, Ontario, Canada
Site Status
Countries
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Canada
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PHN-Peer Co-Led CBT for PPD
Identifier Type: -
Identifier Source: org_study_id
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