Trial Outcomes & Findings for Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT (NCT NCT04630249)
NCT ID: NCT04630249
Last Updated: 2024-10-18
Results Overview
We will compare the proportion of participants that complete a screen for mental health and substance use among those assigned to LTWP, compared to TAU.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
415 participants
Primary outcome timeframe
Baseline
Results posted on
2024-10-18
Participant Flow
Participant milestones
| Measure |
Listening to Women and 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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Usual Care
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
191
|
|
Overall Study
COMPLETED
|
224
|
191
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pregnant participants only.
Baseline characteristics by cohort
| Measure |
Listening to Women and Pregnant and Postpartum People
n=224 Participants
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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Usual Care
n=191 Participants
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Total
n=415 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
n=224 Participants
|
31 years
n=191 Participants
|
31 years
n=415 Participants
|
|
Sex: Female, Male
Female
|
224 Participants
n=224 Participants
|
191 Participants
n=191 Participants
|
415 Participants
n=415 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=224 Participants
|
0 Participants
n=191 Participants
|
0 Participants
n=415 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
70 Participants
n=224 Participants
|
71 Participants
n=191 Participants
|
141 Participants
n=415 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 Participants
n=224 Participants
|
8 Participants
n=191 Participants
|
20 Participants
n=415 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
135 Participants
n=224 Participants
|
110 Participants
n=191 Participants
|
245 Participants
n=415 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=224 Participants
|
2 Participants
n=191 Participants
|
9 Participants
n=415 Participants
|
|
Annual Household Income
Under $25,000 per year
|
46 Participants
n=224 Participants
|
31 Participants
n=191 Participants
|
77 Participants
n=415 Participants
|
|
Annual Household Income
$25,000 per year or more
|
178 Participants
n=224 Participants
|
160 Participants
n=191 Participants
|
338 Participants
n=415 Participants
|
|
Rurality of Patient's Residence
Rural
|
14 Participants
n=224 Participants
|
18 Participants
n=191 Participants
|
32 Participants
n=415 Participants
|
|
Rurality of Patient's Residence
Partially Rural
|
154 Participants
n=224 Participants
|
141 Participants
n=191 Participants
|
295 Participants
n=415 Participants
|
|
Rurality of Patient's Residence
Urban
|
42 Participants
n=224 Participants
|
28 Participants
n=191 Participants
|
70 Participants
n=415 Participants
|
|
Rurality of Patient's Residence
Data Missing
|
14 Participants
n=224 Participants
|
4 Participants
n=191 Participants
|
18 Participants
n=415 Participants
|
|
Number of Living Children
|
1 children
n=224 Participants
|
1 children
n=191 Participants
|
1 children
n=415 Participants
|
|
Number of Pregnancies
|
2 pregnancies
n=224 Participants
|
2 pregnancies
n=191 Participants
|
2 pregnancies
n=415 Participants
|
|
Currently Pregnant
|
102 Participants
n=224 Participants
|
85 Participants
n=191 Participants
|
187 Participants
n=415 Participants
|
|
Number of Weeks Pregnant
|
28.0 weeks
n=102 Participants • Pregnant participants only.
|
28.0 weeks
n=85 Participants • Pregnant participants only.
|
28.0 weeks
n=187 Participants • Pregnant participants only.
|
|
Number of Months Postpartum
|
2.0 months
n=122 Participants • Postpartum participants only.
|
2.0 months
n=106 Participants • Postpartum participants only.
|
2.0 months
n=228 Participants • Postpartum participants only.
|
|
Self-Reported Psychiatric Diagnoses
Mood Disorder
|
35 Participants
n=224 Participants
|
27 Participants
n=191 Participants
|
62 Participants
n=415 Participants
|
|
Self-Reported Psychiatric Diagnoses
Anxiety Disorder
|
67 Participants
n=224 Participants
|
52 Participants
n=191 Participants
|
119 Participants
n=415 Participants
|
|
Self-Reported Psychiatric Diagnoses
Substance Use Disorder
|
21 Participants
n=224 Participants
|
9 Participants
n=191 Participants
|
30 Participants
n=415 Participants
|
|
Self-Reported Psychiatric Diagnoses
Psychotic Disorder
|
0 Participants
n=224 Participants
|
0 Participants
n=191 Participants
|
0 Participants
n=415 Participants
|
|
Self-Reported Psychiatric Diagnoses
None
|
141 Participants
n=224 Participants
|
129 Participants
n=191 Participants
|
270 Participants
n=415 Participants
|
|
Self-Reported EPDS Score
|
5.0 units on a validated scale
n=224 Participants
|
6.0 units on a validated scale
n=191 Participants
|
5.0 units on a validated scale
n=415 Participants
|
|
Self-Reported GAD-7 Score
|
3.0 units on a validated scale
n=224 Participants
|
3.0 units on a validated scale
n=191 Participants
|
3.0 units on a validated scale
n=415 Participants
|
PRIMARY outcome
Timeframe: BaselineWe will compare the proportion of participants that complete a screen for mental health and substance use among those assigned to LTWP, compared to TAU.
Outcome measures
| Measure |
Listening to Women and Pregnant and Postpartum People
n=224 Participants
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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Usual Care
n=191 Participants
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
|---|---|---|
|
Completion of SBIRT (Specific Aim 1)
|
221 Participants
|
63 Participants
|
PRIMARY outcome
Timeframe: BaselineWe will compare the proportion of those screening positive that are referred to treatment among those assigned to LTWP, compared to TAU.
Outcome measures
| Measure |
Listening to Women and Pregnant and Postpartum People
n=224 Participants
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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Usual Care
n=191 Participants
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
|---|---|---|
|
Screened Positive (Specific Aim 1)
|
121 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: BaselineWe will compare the proportion of participants referred to treatment that had at least one mental health and/or substance use disorder treatment appointment among those assigned to LTWP, compared to TAU.
Outcome measures
| Measure |
Listening to Women and Pregnant and Postpartum People
n=224 Participants
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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Usual Care
n=191 Participants
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
|---|---|---|
|
Referred to Treatment (Specific Aim 1)
|
31 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: BaselineTreatment attendance (defined as attending at least 1 or more visits with a mental health and/or substance use disorder (SUD) treatment provider during pregnancy and the postpartum year)
Outcome measures
| Measure |
Listening to Women and Pregnant and Postpartum People
n=224 Participants
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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Usual Care
n=191 Participants
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
|---|---|---|
|
Treatment Attendance (Specific Aim 1)
|
20 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: BaselineAmong those that completed a screen, proportion of participants that screened positive.
Outcome measures
| Measure |
Listening to Women and Pregnant and Postpartum People
n=221 Participants
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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Usual Care
n=63 Participants
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
|---|---|---|
|
Screened Positive (Specific Aim 2)
|
121 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: BaselineAmong those that completed a screen, proportion of participants that were referred to treatment.
Outcome measures
| Measure |
Listening to Women and Pregnant and Postpartum People
n=221 Participants
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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Usual Care
n=63 Participants
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
|---|---|---|
|
Referred to Treatment (Specific Aim 2)
|
31 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: BaselineAmong those that completed a screen, proportion of participants that attended a mental health or substance use treatment appointment.
Outcome measures
| Measure |
Listening to Women and Pregnant and Postpartum People
n=221 Participants
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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Usual Care
n=63 Participants
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
|---|---|---|
|
Treatment Attendance (Specific Aim 2)
|
20 Participants
|
1 Participants
|
Adverse Events
Listening to Women and Pregnant and Postpartum People
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Listening to Women and Pregnant and Postpartum People
n=224 participants at risk
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. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
Treatment as Usual
n=191 participants at risk
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
|
|---|---|---|
|
Nervous system disorders
Hospitalization etiology unknown
|
0.00%
0/224 • Adverse event data was collected from the participant's randomization date through 3 months post randomization.
Events related to hospitalization for labor and delivery were not reported as serious adverse events and adverse events.
|
0.52%
1/191 • Number of events 1 • Adverse event data was collected from the participant's randomization date through 3 months post randomization.
Events related to hospitalization for labor and delivery were not reported as serious adverse events and adverse events.
|
|
Hepatobiliary disorders
Cholecystectomy
|
1.3%
3/224 • Number of events 3 • Adverse event data was collected from the participant's randomization date through 3 months post randomization.
Events related to hospitalization for labor and delivery were not reported as serious adverse events and adverse events.
|
0.00%
0/191 • Adverse event data was collected from the participant's randomization date through 3 months post randomization.
Events related to hospitalization for labor and delivery were not reported as serious adverse events and adverse events.
|
|
Pregnancy, puerperium and perinatal conditions
Percutaneous umbilical blood sampling-Intrauterine Transfusion (PUBS-IUT)
|
0.00%
0/224 • Adverse event data was collected from the participant's randomization date through 3 months post randomization.
Events related to hospitalization for labor and delivery were not reported as serious adverse events and adverse events.
|
0.52%
1/191 • Number of events 1 • Adverse event data was collected from the participant's randomization date through 3 months post randomization.
Events related to hospitalization for labor and delivery were not reported as serious adverse events and adverse events.
|
|
Infections and infestations
Mastitis with Abscess
|
0.00%
0/224 • Adverse event data was collected from the participant's randomization date through 3 months post randomization.
Events related to hospitalization for labor and delivery were not reported as serious adverse events and adverse events.
|
0.52%
1/191 • Number of events 1 • Adverse event data was collected from the participant's randomization date through 3 months post randomization.
Events related to hospitalization for labor and delivery were not reported as serious adverse events and adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Constance Guille
The Medical University of South Carolina
Phone: 843-792-6489
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place