Clinical trial NCT05764213: Improving Maternal Mental Health & SUD Screening and Treatment
Official title: Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mental Health Issue
Substance Use Disorders
Postpartum Depression
Postpartum Anxiety
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-03-10
Enrollment: 9444
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Treatment Attendance
timeFrame: Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months
measure: Change in Retention in Treatment
timeFrame: Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months
Secondary outcomes:
measure: Change in depressive symptoms
timeFrame: Change from baseline depression screening symptoms to follow-up depression screening symptoms during the postpartum year, approximately over 21 months.
measure: Change in Substance Use
timeFrame: Change from baseline substance use to follow-up substance use during the postpartum year, approximately over 21 months.
measure: Change in Maternal Functioning and Wellbeing
timeFrame: Change from baseline maternal functioning to follow-up maternal functioning during the postpartum year, approximately over 21 months.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Constance Guille, MD
role: PRINCIPAL_INVESTIGATOR
References: