Improving Maternal Mental Health & SUD Screening and Treatment

Substance Use Disorders Clinical Trial

Official title:

Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05764213
• Other study ID #: 00123833
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: July 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 the time of referral (baseline=0) and 2, 5, 8, and 11 months postpartum.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 9444
• Est. completion date: October 1, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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:

None

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:

a.) Unable to complete study assessments

Related Conditions & MeSH terms

• Depression, Postpartum
• Mental Health Issue
• Postpartum Anxiety
• Postpartum Depression
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in depressive symptoms	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.	Change from baseline depression screening symptoms to follow-up depression screening symptoms during the postpartum year, approximately over 21 months.
Secondary	Change in Substance Use	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).	Change from baseline substance use to follow-up substance use during the postpartum year, approximately over 21 months.
Secondary	Change in Maternal Functioning and Wellbeing	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.	Change from baseline maternal functioning to follow-up maternal functioning during the postpartum year, approximately over 21 months.