Maternal Mental Health in the Hospital Setting

NCT03777046 | Completed

• 1 other identifier: H44040
• Study Type: interventional
• Target: 545
• Locations: 1 country
• Sites: 2

Brief Summary

Perinatal (around the time of birth) mental health disorders are common difficulties of pregnancy. Perinatal depression is made up of major and minor depressive events during pregnancy and the first 12 months after delivery. It is estimated that 11%-19% of mothers suffer from perinatal depression. However, rates may be significantly higher among some subpopulations. Left untreated, post partum depression (PPD) is linked with several significant negative health impacts on the mother, her infant, and their families. PPD is linked with lower quality maternal-child relationship, and this change in emotional attachment can lead to physiologic changes and poorer cognitive outcomes in the infant. The purpose of this study is to determine the maternal mental health effect of postpartum depression screening and intervention during infants' short term hospitalizations. The study is also aiming to define effects of PPD short term hospitalization interventions on maternal PPD follow up and child health based on well child care (WCC), emergency department (ED) visits, hospital readmissions, and parent's feelings on child's health.

Conditions

Post Partum Depression

Keywords

PPD; Post Partum; Post Partum Depression

Outcome Measures

Primary Outcomes (1)

• Difference in PPD score

  PPD score will be measured using the Edinburgh Postnatal Depression Scale (EPDS). A score less than 8 suggests depression is not likely. A score of 9-11 suggests depression is possible. A score of 12-13 indicates fairly high possibility of depression. A score of 14 and higher suggest probable depression. Positive score of 1, 2 or 3 on question 10 suggests there is a suicidality risk.

  at Month 1

Study Arms (3)

Screen fail subjects

NO INTERVENTION

Mothers and their babies that meet inclusion criteria for the study, but score less than 10 on the Edinburgh Postpartum Depression Scale (EPDS)

PPD Control subjects

ACTIVE COMPARATOR

Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD.

Behavioral: Standard of Care (SOC)

PPD Intervention subjects

EXPERIMENTAL

Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital.

Behavioral: SOC with Psychology Therapy (CBT)

Interventions

Standard of Care (SOC) BEHAVIORAL

Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD.

PPD Control subjects

SOC with Psychology Therapy (CBT) BEHAVIORAL

Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital.

PPD Intervention subjects

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on the population being studied, only females with children that have given birth will be included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years old.
• Mothers of infants ≤365 days of age admitted to the acute care floors at Texas Children's Hospital Medical Center Campus and their infant based on date of birth in Epic.
• English or Spanish speaking mother.
• Willing and able to provide informed consent.
• Mothers with Edinburgh Postpartum Depression Scale (EPDS) score more than or equal to 10
• Ability to complete study protocol.

You may not qualify if:

• Mother and infant(s) reside outside 50-mile radius of Texas Children's Hospital Medical Center Campus based on address on demographic form.
• Mother is not the primary caregiver of infant(s) confirmed at time of informed consent.
• Enrollment in this study during previous hospitalization based on duplicate identified in database.
• Currently under care of psychiatrist or psychologist as reported in screening questionnaire.

Sponsors & Collaborators

• Michelle Lopez: lead

Study Sites (2)

Texas Children's Hospital - Women's Pavilion

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michelle Lopez, MD

  Texas Children's Hospital/Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 17, 2018
• Study Start: January 24, 2019
• Primary Completion: March 13, 2020
• Study Completion: May 22, 2020
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)