Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03932760 |
| Other study ID # |
IRB_00113917 |
| Secondary ID |
R01NR017620 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2020 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of the project is to evaluate for the first time, the effectiveness of using a
telehealth approach to reducing perinatal depressive symptoms in diverse groups of
childbearing women; urban and rural-dwelling, and from Hispanic and predominantly North
European Descent populations. Pregnant women connect for one hour weekly, for 8 weeks, using
their own electronic device, from whatever location they choose (e.g. home), to attend
videoconference groups facilitated by a mental health professional. The approach is cost
effective and reduces barriers to access to mental health services, particularly for women
living in rural, low-resource, and minority communities, and those without adequate
transportation, financial resources, childcare, or work release time.
Description:
Perinatal depression (PD) affects 12-15% of women and contributes to adverse outcomes, e.g.
preterm birth, low birth weight, and impaired cognitive development of the child. Screening
optimizes the detection of PD, but does not reduce barriers to mental health services (MHS)
encountered by women who screen positive. A known shortage of MHS across the nation is a
significant barrier, particularly in low resource and rural settings. Telehealth is a
promising approach to reducing barriers, but there is little research on the effectiveness of
telehealth to reduce perinatal depressive symptoms (PDS). There is high potential for
telehealth to deliver effective, lower cost MHS to childbearing women, particularly those in
low resource settings.
The proposed project is a randomized controlled trial among women with mild to moderate PDS.
The project aims to evaluate; 1) the effectiveness of a group mental health videoconference
intervention (VCI) to reduce PDS across pregnancy and postpartum, and (2) differences in PDS
between diverse groups of childbearing women: rural and urban-dwelling, and Latina and
predominantly North European Descent (NED) populations. The investigators hypothesize that
women participating in the VCI will have significantly lower PDS across pregnancy and
postpartum than women in an equivalent attention control (AC) group, and the results will
differ between diverse groups. A total of 192 women will be enrolled; 48 in each study group.
Participants are randomly assigned to study groups: VCI +standard of care, or AC + standard
of care. Sessions are delivered via Utah Telehealth Network (UTN). Women in both groups
attend weekly one-hour group sessions for 8 weeks using any electronic device (laptop,
tablet, smart phone) from their own home. PDS is measured six times throughout
enrollment--Time 1 = pre-intervention; T2 = immediately following week 9 of group
intervention classes (post-intervention), T3= 2 months post-intervention; T4= 4 months
post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention.
This study is the first to use a VCI to engage women in a facilitated group approach to
reducing PDS, and to evaluate the impact among diverse groups. The approach is cost effective
and reduces barriers to access to MHS, particularly for women living in low-resource, and
minority communities, and those without adequate transportation, childcare, or work release
time. The VCI can be replicated in any setting (e.g. rural or urban), and can be adapted to
the needs of diverse communities. The study advances the field by establishing whether a
group telehealth intervention reduces PDS, and whether this differs based on the population.
If effective and implemented broadly, far fewer women and families would suffer the negative
consequences of depression. The project is in line with NINR's high priority areas, including
the use of technology to promote health, and a focus on self-management and symptom science.
