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Telehealth Group Intervention for Perinatal Depressive Symptoms (TePOP)

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ClinicalTrials.gov Identifier: NCT03932760
Recruitment Status : Not yet recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Utah

Brief Summary:
Our goal 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.

Condition or disease Intervention/treatment Phase
Perinatal Depression Behavioral: UPLIFT Program Behavioral: Attention Control Group Not Applicable

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. We 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 at 3 time points in pregnancy and 3 time points in postpartum.

Our 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 proposed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Telehealth Group Intervention to Reduce Perinatal Depressive Symptoms in Diverse Populations
Estimated Study Start Date : April 22, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Depressive Symptoms Over Time [ Time Frame: Time 1 = pre-intervention; T2 = post-intervention, approximately 12 weeks after pre-intervention; T3= 35 weeks gestations; T4 = 2 months postpartum; T5 = 4 months postpartum; T6 = 6 months postpartum ]
    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.


Secondary Outcome Measures :
  1. Change in Anxiety Symptoms Over Time [ Time Frame: Time 1 = pre-intervention; T2 = post-intervention, approximately 12 weeks after pre-intervention; T3= 35 weeks gestations; T4 = 2 months postpartum; T5 = 4 months postpartum; T6 = 6 months postpartum ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant and postpartum women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women age 18 and older
  • have a viable pregnancy, less than or equal to 20 weeks of pregnancy
  • have an 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
  • are taking any medications for a mental health condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932760


Contacts
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Contact: Susan Dearden, MPH 8016318025 susan.dearden@utah.edu
Contact: Ryoko Pentecost, BSN, MS 2089942806 ryoko.pentecost@utah.edu

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

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03932760     History of Changes
Other Study ID Numbers: IRB_00113917
R01NR017620 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The PI agrees to make available data within one year of the completion of the funded project period
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms