Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03285139 |
| Other study ID # |
PL CBT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2018 |
| Est. completion date |
February 28, 2020 |
Study information
| Verified date |
March 2022 |
| Source |
McMaster University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers
and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based
care. This is at least partly due to significant difficulties faced by women in accessing
cognitive behavioural therapy (CBT), a preferred 1st line treatment. In Ontario at present,
there is a significant lack of personnel trained to deliver CBT. This study will utilize a
randomized controlled trial design (with wait list controls) and recruit 70 participants to
determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver
effective group CBT to women with current PPD. If peers can be trained to provide effective
CBT, more women would receive treatment and the burden of PPD on women, families, and the
healthcare system would be significantly reduced.
Description:
Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers
and their infants. Indeed, the cost of one case of PPD is estimated to exceed $150,000.
Unfortunately, fewer than 15% of women with PPD receive evidence-based care and this is at
least partly due to difficulties accessing treatment, particularly those that are most
preferred (e.g., psychotherapy).
Clinical practice guidelines recommend that the majority of women with PPD receive
psychotherapy (e.g., cognitive behavioural therapy (CBT)) as a 1st-line treatment and that
screening only occur in settings where CBT is readily available. In order to increase access
to treatment, screening efforts have been undertaken by public health units province-wide.
This is despite recommendations that this only be conducted in the setting of timely access
to evidence-based psychotherapies (e.g., CBT). The purpose of this study is to apply task
shifting to the treatment of PPD by determining if women with a past history of PPD (i.e.,
lay peers) living in the community can be trained to deliver effective group CBT to women
with current PPD.
A group CBT intervention for PPD has been developed and validated as well as a training
program that pilot data suggests is capable of successfully training public health nurses
with little background psychiatric training. This intervention is brief, effective, and
generalizable to women with PPD in community. Peer administered interventions (PAIs), those
delivered by recovered former patients are increasingly recognized as potentially effective
alternatives to traditional mental health care services. Eight lay peers will be trained to
deliver our 9-week group CBT treatment. 74 women will be recruited and using a randomized
controlled trial design (with wait list controls), it will be determined if lay peers can
deliver effective group CBT for PPD.
If peers can be trained to provide effective CBT, 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.
