Back to resultsImproving Maternal Mental Health & SUD Screening and Treatment
Primary Purpose
Mental Health Issue, Substance Use Disorders, Postpartum Depression
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Listening to Women & Pregnant and Postpartum People
Sponsored by
About this trial
This is an interventional screening trial for Mental Health Issue
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: Age 18-45 pregnant and entering prenatal care in one of MUSC's OB clinics 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: Age 18-45 years pregnant attended an initial prenatal appointment at an MUSC OB clinic Exclusion: a.) Unable to complete study assessments
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Screening Brief Intervention & Referral to Treatment (SBIRT)
Listening to Women & Pregnant & Postpartum People (LTWP)
Arm Description
This group will receive in-person screening and referral to treatment assessment.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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 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 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.
Full Information
NCT ID
NCT05764213
First Posted
February 17, 2023
Last Updated
July 11, 2023
Sponsor
Medical University of South Carolina
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05764213
Brief Title
Improving Maternal Mental Health & SUD Screening and Treatment
Official Title
Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 the time of referral (baseline=0) and 2, 5, 8, and 11 months postpartum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Substance Use Disorders, Postpartum Depression, Postpartum Anxiety
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9444 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Screening Brief Intervention & Referral to Treatment (SBIRT)
Arm Type
No Intervention
Arm Description
This group will receive in-person screening and referral to treatment assessment.
Arm Title
Listening to Women & Pregnant & Postpartum People (LTWP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Listening to Women & Pregnant and Postpartum People
Intervention Description
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 Outcome Measure Information:
Title
Change in Treatment Attendance
Description
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
Title
Change in Retention in Treatment
Description
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 Outcome Measure Information:
Title
Change in depressive symptoms
Description
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.
Title
Change in Substance Use
Description
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.
Title
Change in Maternal Functioning and Wellbeing
Description
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
Age 18-45
pregnant and entering prenatal care in one of MUSC's OB clinics
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:
Age 18-45 years
pregnant
attended an initial prenatal appointment at an MUSC OB clinic
Exclusion:
a.) Unable to complete study assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance Guille, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Maternal Mental Health & SUD Screening and Treatment
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