Mental Health IssueNCT05764213
Improving Maternal Mental Health & SUD Screening and Treatment
A study testing Listening to Women & Pregnant and Postpartum People in people with Mental Health Issue and Substance Use Disorders, run by Medical University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Substance Use Disorders, Postpartum Depression
- What is being tested?
- Listening to Women & Pregnant and Postpartum People
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,469 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45
- pregnant and entering prenatal care in one of MUSC's OB clinics
- attended a prenatal appointment at an MUSC clinic
- Age 18-45 years
- pregnant
- attended an initial prenatal appointment at an MUSC OB clinic
Who cannot join
- a.) primary language is not English or Spanish
- Aim 2:
- Study Assessments at baseline and 2, 5, 8, and 11 months postpartum (PPP):
- Unable to complete study assessments
- primary language is not English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Improving Maternal Mental Health & Substance Use Disorder 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.
Read the 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.
- Being tested
- Listening to Women & Pregnant and Postpartum People
- Medical subject headings
- Substance-Related Disorders, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to Women & Pregnant and Postpartum PeopleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening Brief Intervention & Referral to Treatment (SBIRT) | No intervention | This group will receive in-person screening and referral to treatment assessment. |
| Listening to Women & Pregnant & Postpartum People (LTWP) | Experimental | 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. Receives: Behavioral: Listening to Women & Pregnant and Postpartum People |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: Change from baseline maternal functioning to follow-up maternal functioning during the postpartum year, approximately over 21 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start3 Apr 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Constance Guille, Medical University of South Carolina
- Investigators
- Constance Guille, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764213
- Sponsor's protocol ID
- 00123833
- Status last verified
- Oct 2026
- First submitted
- 17 Feb 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment
- ClinicalTrials.gov ID
- NCT05764213
- Acronym / sponsor ID
- 00123833
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,469 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening Brief Intervention & Referral to Treatment (SBIRT) | No intervention | –This group will receive in-person screening and referral to treatment assessment. |
| Listening to Women & Pregnant & Postpartum People (LTWP) | Experimental | Behavioral: Listening to Women & Pregnant and Postpartum PeopleThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45
- pregnant and entering prenatal care in one of MUSC's OB clinics
- attended a prenatal appointment at an MUSC clinic
- Age 18-45 years
- pregnant
Key exclusion criteria (5 listed)
- a.) primary language is not English or Spanish
- Unable to complete study assessments
- primary language is not English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening to Women & Pregnant and Postpartum PeopleParticipants 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. | Behavioural | Listening to Women & Pregnant & Postpartum People (LTWP) |
Primary outcome
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.
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.
3 secondary outcomes
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.
Change in Substance Use
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
Time frame: Change from baseline maternal functioning to follow-up maternal functioning during the postpartum year, approximately over 21 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constance Guille, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to Women & Pregnant and Postpartum People in people with Mental Health Issue and Substance Use Disorders, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Treatment Attendance (time frame: Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.