Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597448
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Public Health Nurse-Peer Co-Led Group Cognitive Behavioral Therapy for Postpartum Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Public Health Nurse-Peer Co-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 mothersbirthing 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None