Improving Maternal Mental Health & SUD Screening and Treatment

N/AActive Not RecruitingNCT05764213

Medical University of South Carolina10,470 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

10,470

Conditions

Mental Health Issue Substance Use Disorders

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

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.

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

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).

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

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.

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