Improving Maternal Mental Health & SUD Screening and Treatment

Medical University of South Carolina (MUSC)

Status: Active, not recruiting

Conditions: Postpartum Anxiety; Mental Health Issue; Substance Use Disorders; Postpartum Depression

Treatments: Behavioral: Listening to Women & Pregnant and Postpartum People

Study type: Interventional

Funder types: Other

Identifiers

NCT05764213

00123833

Details and patient eligibility

About

The purpose of the study is to compare a text message-based mental health and substance use screening and referral to a treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online questionnaires. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.

Full description

Aim 1: To determine differences in rates of treatment attendance and retention for Perinatal Mood and Anxiety Disorders (PMADs) and Perinatal Substance Use Disorders (PSUDs) between participants assigned to LTWP, compared to SBIRT.

Aim 2: To determine differences in Patient-Reported Outcomes (PROs) including depressive symptoms, quality of life, substance use, and maternal functioning and well-being measured at baseline and 2, 5, 8, and 11 months postpartum.

Enrollment: 10,473 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Aim 1:

This study is a cluster RCT step wedge design so we are randomizing on the clinic level, not the individual level. The clinics are made up of 4 "wedges" (3 clinics/wedge). Pregnant women receiving prenatal care in these clinics will receive SBIRT as part of usual care. Clusters of clinics will be randomized to an LTWP start date where they will transition from SBIRT to LTWP for the purposes of screening and referral to treatment.

EHR Data Collection (PPP):

Inclusion:

1. Age 18-45
2. pregnant and entering prenatal care in one of MUSC's OB clinics
3. attended a prenatal appointment at an MUSC clinic

Exclusion:

a.) primary language is not English or Spanish

Aim 2:

Study Assessments at baseline and 2, 5, 8, and 11 months postpartum (PPP):

Inclusion:

1. Age 18-45 years
2. pregnant
3. attended an initial prenatal appointment at an MUSC OB clinic

Exclusion:

1. Unable to complete study assessments
2. primary language is not English or Spanish

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,473 participants in 2 patient groups

Screening Brief Intervention & Referral to Treatment (SBIRT)

No Intervention group

Description:

This group will receive in-person screening and referral to treatment assessment.

Listening to Women & Pregnant & Postpartum People (LTWP)

Experimental group

Description:

This group will receive text-message-based SBIRT with phone-based assessment and referral to treatment. The SBIRT is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, and other drugs including prescription medication), and domestic violence.

Treatment:

Behavioral: Listening to Women & Pregnant and Postpartum People