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Active, Not Recruiting

NCT Number: NCT05764213

Improving Maternal Mental Health & SUD Screening and Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mental Health Issue Chemically-Induced Disorders Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Anxiety Postpartum Depression Pregnancy Complications Puerperal Disorders Substance Use Disorders Substance-Related Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • Age 18-45
  • pregnant and entering prenatal care in one of MUSC's OB clinics
  • 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:

  • Age 18-45 years
  • pregnant
  • attended an initial prenatal appointment at an MUSC OB clinic

Exclusion:

  • Unable to complete study assessments
  • primary language is not English or Spanish

Treatment and study plan

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.

Primary outcomes

  1. Change in Treatment Attendance

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

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

  2. Change in Retention in Treatment

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

    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.

Secondary outcomes

  1. Change in depressive symptoms

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

    We will compare the mean change in the Edinburgh Postnatal Depression Scale (EPDS) among those assigned to LTWP compared to SBIRT.

    A score of 10 or more on the EPDS suggests clinically elevated depressive symptoms requiring further evaluation.

    A higher score on the EPDS is a worse outcome.

  2. Change in Substance Use

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

    We will compare the change in substance use frequency and amount as measured by the ASSIST among those assigned to LTWP compared to SBIRT.

    A score of 0-3 (0-4 for cannabis) has an indicated response for brief education, a score of 4-26 (5-26 for cannabis) has an indicated response for brief intervention, a score of 27+ has an indicated response for brief intervention (offer options that include treatment).

  3. Change in Maternal Functioning and Wellbeing

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

    We will compare the change in maternal functioning measured by the Barkin Index of Maternal Functioning among those assigned to LTWP compared to SBIRT.

    Each item is rated on a 7-point likert scale ranging from 0 = "strongly disagree" to 6 = "strongly agree". The total score ranges from 0 to 120. Higher levels of functioning are associated with higher total scores with 120 representing optimal functioning. Lower levels of functioning are associated with lower scores.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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