Clinical trial NCT03932760: Telehealth Group Intervention for Perinatal Depressive Symptoms
Official title: Randomized Trial of Telehealth Group Intervention to Reduce Perinatal Depressive Symptoms in Diverse Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-05-01
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* women age 18 and older
* have a viable pregnancy (any gestational age) or postpartum (up to 6 months)
* have an Edinburgh Postpartum Depression Scale (EPDS) score between 9 and 20
* are English or Spanish speaking
* are receiving clinical services at a collaborating prenatal or public health clinic associated with the U of Utah or Utah rural Health Districts

Exclusion Criteria:

* women who have an EPDS score less than 9 or greater than 20
* have a current diagnosis of a serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression, suicidal ideation, homicidal ideation
* begun taking or changed dosage of any medications for a mental health condition within the previous 6 weeks

Primary outcomes:
measure: Change in Depressive Symptoms Over Time
timeFrame: Time 1 = pre-intervention (Baseline); T2 = immediately following week 9 of group intervention classes (Post), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention
Secondary outcomes:
measure: Change in Anxiety Symptoms Over Time
timeFrame: 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
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Gwen Latendresse, PhD
role: PRINCIPAL_INVESTIGATOR
References: