Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2026-01-03 @ 6:52 PM
Study NCT ID:
NCT03654261
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2018-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1-Day CBT Workshops for PPD
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
1-Day Cognitive Behavioural Therapy Workshops for Postpartum Depression
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.
Detailed Description:
Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families (1,2). Indeed, the cost of one case of PPD is estimated to exceed $150,000 (3). Unfortunately, fewer than 15% of women with PPD receive evidence-based care (4), which is at least partly due to difficulties accessing treatment, particularly therapies that are most preferred (e.g., psychotherapy (5)).
Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment (6). Moreover, consensus recommendations such as those made by the US Preventive Services Task Force suggest that screening only occur in settings where evidence-based counselling such as CBT is readily available (7). In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide in Ontario. This has occurred despite the widespread availability of evidence-based psychotherapies.
A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each of 5 settings (Simcoe County, Kitchener-Waterloo Region, Halton Region, Prince Edward County, Elgin County), and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.
If this intervention is eventually proven effective, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.
Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment (6). Moreover, consensus recommendations such as those made by the US Preventive Services Task Force suggest that screening only occur in settings where evidence-based counselling such as CBT is readily available (7). In order to increase access to treatment, screening efforts have been undertaken by public health units province-wide in Ontario. This has occurred despite the widespread availability of evidence-based psychotherapies.
A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each of 5 settings (Simcoe County, Kitchener-Waterloo Region, Halton Region, Prince Edward County, Elgin County), and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.
If this intervention is eventually proven effective, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced. Providing women with PPD with CBT skills at this crucial stage in life also has the capacity to prevent future depressive relapse with significant benefits for patients, families, employers, and the healthcare system.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: