Improving Maternal Mental Health & SUD Screening and Treatment

NCT05764213 | Active Not Recruiting DMC

• 1 other identifier: 00123833
• Study Type: interventional
• Target: 10,470
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in Treatment Attendance

  Treatment attendance is defined as attending at least 1 or more visits with a mental health or substance use disorder treatment provider.

  Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months

• Change in Retention in Treatment

  Retention in treatment for PMADs: defined as 6 or more psychotherapy visits and/or 4 or more medication management visits; and PSUDs: are defined as continuous pharmacological and/or behavioral treatment \> 2 months.

  Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months

Secondary Outcomes (3)

• Change in depressive symptoms

  Change from baseline depression screening symptoms to follow-up depression screening symptoms during the postpartum year, approximately over 21 months.

• Change in Substance Use

  Change from baseline substance use to follow-up substance use during the postpartum year, approximately over 21 months.

• Change in Maternal Functioning and Wellbeing

  Change from baseline maternal functioning to follow-up maternal functioning during the postpartum year, approximately over 21 months.

Study Arms (2)

Screening Brief Intervention & Referral to Treatment (SBIRT)

NO INTERVENTION

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

Listening to Women & Pregnant & Postpartum People (LTWP)

EXPERIMENTAL

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.

Behavioral: Listening to Women & Pregnant and Postpartum People

Interventions

Listening to Women & Pregnant and Postpartum People 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.

Listening to Women & Pregnant & Postpartum People (LTWP)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• a.) primary language is not English or Spanish
• Aim 2:
• Study Assessments at baseline and 2, 5, 8, and 11 months postpartum (PPP):
• Age 18-45 years
• pregnant
• attended an initial prenatal appointment at an MUSC OB clinic
• Unable to complete study assessments
• primary language is not English or Spanish

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute: collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Depression, Postpartum

Interventions

Gravidity

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Pregnancy; Reproduction; Reproductive History; Epidemiologic Factors; Public Health; Environment and Public Health

Study Officials

• Constance Guille, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 10, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2025-11

Locations

US (1)