Trials / Active Not Recruiting
Active Not RecruitingNCT06597448
Public Health Nurse-Peer Co-Led Group Cognitive Behavioral Therapy for Postpartum Depression
Public Health Nurse-Peer Co-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- Sponsor
- McMaster University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2024-09-16
- Primary completion
- 2027-06-01
- Completion
- 2028-01-01
- First posted
- 2024-09-19
- Last updated
- 2025-12-09
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06597448. Inclusion in this directory is not an endorsement.