Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04617132 |
| Other study ID # |
H20-01884 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 20, 2020 |
| Est. completion date |
September 2023 |
Study information
| Verified date |
February 2023 |
| Source |
British Columbia Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to explore the feasibility of delivering clinical mindfulness groups
for families affected with postpartum depression and anxiety (PPDA). Families with PPDA are a
vulnerable population who already face challenges during the postpartum period, but now the
Covid-19 era has brought extra challenges - lower availability of family members or support
systems to help in person, older children at home as childcare facilities are closed, etc.
Clinical mindfulness groups are now being run online to support this population, with the
current barriers of having to stay at home. Through this study, we want to capture the
challenges that both clinicians and participants might face using virtual platforms (e.g.
technical difficulties), to see whether online delivery of clinical mindfulness groups is
feasible.
Description:
Postpartum depression and anxiety (PPDA) is a prevalent condition, affecting about every 1 in
5 families. This not only impacts the parent diagnosed with PPDA but also affects
relationships with the rest of the family, ability to bond with her child, and can cause
tension between the parents. Thus, it is important that steps are taken to effectively treat
and support families affected by PPDA in a timely manner. On top of the struggles with a
newborn baby, the Covid era has brought along some new challenges. One such challenge is that
many healthcare providers and clinics have limited capacities or the care they provide may be
limited due to lockdown and Covid-19. Another challenge is the decreased in-person support
from family and other support systems, as well as having older children at home all the time
due to childcare facilities being closed.
As it is important to offer this population some support, this study is being conducted to
see if continuing the clinical groups and turning them onto a distant, online format would be
possible, and if it would work for both clinicians and the postpartum population.
The aim of the study is to determine the feasibility of running online clinical mindfulness
groups, particularly examining whether patients are able to access and continue with the
online sessions. Feasibility will be assessed by frequency of technical difficulties faced by
patients or clinicians and number of disruptions or episodes of parents leaving their screens
(e.g. to calm their child), self-report items of how participants found attending online
sessions and following the program, and attendance and drop-out rates. Secondary outcomes of
this study include reasons for drop-outs, satisfaction and acceptability, couple
interactions, and mental health outcomes.
The mindfulness groups will be rooted in the evidence-based 8-week programs, including
Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), and
adapted for this population needs. The mindfulness groups will run once a week, totalling 8
sessions over the course of 8 weeks. These groups will be run by trained clinicians and
mindfulness facilitators and will be a part of the RMH clinical program.
