Telehealth Group Intervention for Perinatal Depressive Symptoms (TePOP)

Randomized Trial of Telehealth Group Intervention to Reduce Perinatal Depressive Symptoms in Diverse Populations

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.

Study Overview

• Status: Completed
• Conditions: Perinatal Depression
• Intervention / Treatment: Behavioral: UPLIFT Program; Behavioral: Attention Control Group

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UPLIFT Program; Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.	Behavioral: UPLIFT Program; UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
Active Comparator: Pregnancy Skills Group; Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.	Behavioral: Attention Control Group; Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depressive Symptoms Over Time	Self-completed: Edinburgh Postnatal Depression Scale measures depression symptoms during pregnancy and postpartum. The instrument will measure depressive symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-30, with 0 indicating no symptoms, and 30 indicating the highest severity of symptoms. Scores < 10 = no depressive symptoms; 10-15 = mild; 16-20 = moderate; > 20 = severe.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Symptoms Over Time	Self-completed: Generalized Anxiety Disorder - 7 Item scale measures symptoms of anxiety. The instrument will measures anxiety symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-21, with 0 indicating no symptoms, and 21 indicating the highest severity of symptoms. Scores of < 5 = no anxiety; 5-9 = mild; 10-14 = moderate; > 15 = severe.	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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Gwen Latendresse, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: IRB_00113917; R01NR017620 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI will share de-identified data to other investigators for study, including demographics, outcomes, communication methodology, and design. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. The PI agrees to make available data within one year of the completion of the funded project period and manuscripts pertaining to the aims. The PI agrees to share data in a manner that is fully consistent with NIH data sharing policies and applicable laws and regulations.
• IPD Sharing Time Frame: The PI agrees to make available data within one year of the completion of the funded project period
• IPD Sharing Access Criteria: Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No