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Improving Maternal Mental Health & SUD Screening and Treatment

NCT ID: NCT05764213

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10473 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2027-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mental Health Issue Substance Use Disorders Postpartum Depression Postpartum Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening Brief Intervention & Referral to Treatment (SBIRT)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Listening to Women & Pregnant & Postpartum People (LTWP)

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.

Group Type EXPERIMENTAL

Listening to Women & Pregnant and Postpartum People

Intervention Type BEHAVIORAL

Participants are enrolled in text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, home-based telemedicine mental health and substance use disorder treatment services.

Interventions

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Listening to Women & Pregnant and Postpartum People

Participants are enrolled in text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, home-based telemedicine mental health and substance use disorder treatment services.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Constance Guille

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Constance Guille, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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00123833

Identifier Type: -

Identifier Source: org_study_id