Telehealth Group Intervention for Perinatal Depressive Symptoms

NCT03932760 | Completed Results DMC

• 2 other identifiers: IRB_00113917R01NR017620
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Anxiety Symptoms Over Time

  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

Study Arms (2)

UPLIFT Program

EXPERIMENTAL

Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.

Behavioral: UPLIFT Program

Pregnancy Skills Group

ACTIVE COMPARATOR

Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.

Behavioral: Attention Control Group

Interventions

UPLIFT Program BEHAVIORAL

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.

UPLIFT Program

Attention Control Group BEHAVIORAL

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.

Pregnancy Skills Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant and postpartum women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Iacob E, Kausler R, Williams M, Simonsen S, Smid M, Weissinger K, Latendresse G. Protocol for a randomized controlled trial to evaluate the effectiveness of a telehealth group intervention to reduce perinatal depressive symptoms. Contemp Clin Trials. 2024 Dec;147:107738. doi: 10.1016/j.cct.2024.107738. Epub 2024 Nov 13.

  PMID: 39542133 DERIVED

Limitations and Caveats

Limitations included low recruitment (largely due to COVID-19), difficulty in identifying participation in either group as the cause of lower EPDS scores 8 months after participation, and difficulty in accounting for factors impacting personal changes that can occur in the 10 months of involvement in the study.

Results Point of Contact

• Title: Gwen Latendresse
• Organization: University of Utah

Gwen.Latendresse@nurs.utah.edu

801-587-9636

Study Officials

• Gwen Latendresse, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Dean, Associate Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 1, 2019
• Study Start: May 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 4, 2024
• Results First Posted: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)