Clinical trial NCT06597448: Public Health Nurse-Peer Co-Led Group Cognitive Behavioral Therapy for Postpartum Depression
Official title: Public Health Nurse-Peer Co-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Keywords: Postpartum depression, PPD
Cognitive Behavioural Therapy
Public Health Nurse
Peer
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Niagara Region Public Health
First posted: 2024-09-19
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Postpartum Depression
timeFrame: 9 weeks (post treatment/intervention)
measure: Major Depressive Disorder
timeFrame: 9 weeks (post treatment/intervention)
measure: Major Depressive Disorder
timeFrame: 6 months (durability of intervention effects)
measure: Postpartum Depression
timeFrame: 6 months (durability of intervention effects)
Secondary outcomes:
measure: Parenting Stress
timeFrame: 9 weeks (post treatment/intervention)
measure: Parenting Stress
timeFrame: 6 months (durability of intervention effects)
measure: Healthcare Resource Utilization Questionnaire
timeFrame: 9 weeks (post treatment/intervention)
measure: Healthcare Resource Utilization Questionnaire
timeFrame: 6 months (durability of intervention effects)
measure: Other Psychiatric Disorders
timeFrame: 9 weeks (post treatment/intervention)
measure: Other Psychiatric Disorders
timeFrame: 6 months (durability of intervention effects)
measure: Postpartum Anxiety
timeFrame: 9 weeks (post treatment/intervention)
measure: Postpartum Anxiety
timeFrame: 6 months (durability of intervention effects)
measure: Social Support
timeFrame: 9 weeks (post treatment/intervention)
measure: Social Support
timeFrame: 6 months (durability of intervention effects)
measure: Infant Temperament
timeFrame: 6 months (durability of intervention effects)
measure: Infant Temperament
timeFrame: 9 weeks (post treatment/intervention)
measure: Mother-Infant Relationship
timeFrame: 9 weeks (post treatment/intervention)
measure: Mother-Infant Relationship
timeFrame: 6 months (durability of intervention effects)
measure: Postpartum Anxiety
timeFrame: 9 weeks (post treatment/intervention)
measure: Postpartum Anxiety
timeFrame: 6 months (durability of intervention effects)
measure: EQ-5D-5L
timeFrame: 9-week (post treatment/intervention)
measure: EQ-5D-5L
timeFrame: 6-month (durability of intervention effects)
Other outcomes:
measure: Fidelity of Intervention Delivery
timeFrame: Weekly during the 9-week intervention
measure: Assess Participant Satisfaction
timeFrame: 9-week (post treatment/intervention)
measure: Psychotherapy Experience
timeFrame: 9 weeks (post treatment/intervention)
measure: Psychotherapy Experience
timeFrame: 6 months (durability of intervention effects)
measure: Personal Attributes
timeFrame: 9 weeks (post treatment/intervention)
measure: Personal Attributes
timeFrame: 6 months (durability of intervention effects)
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Ryan J Van Lieshout, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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