Public Health Nurse-Peer Co-Led Group Cognitive Behavioral Therapy for Postpartum Depression

McMaster University

Status: Enrolling

Conditions: Postpartum Depression

Treatments: Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD)

Study type: Interventional

Funder types: Other

Identifiers

NCT06597448

PHN-Peer Co-Led CBT for PPD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 170 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

170 participants in 2 patient groups

Online CBT Group

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD)

Treatment as Usual

No Intervention group

Description:

Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed.