Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Specific Aim 1: Conduct a pilot, small-scale randomized controlled trial to examine feasibility and preliminary efficacy of LTW, compared to TAU. Outcomes related to feasibility include percentage of eligible patients recruited, study attrition, study retention, and mental health and substance use treatment appointment attendance. Outcomes related to preliminary efficacy will include participation in screening, referral and treatment at baseline, compared to TAU.
Specific Aim 2: Conduct a randomized controlled trial to examine the effectiveness of LTW, compared to TAU. Outcomes related to effectiveness include screening, screening positive, referred to and attendance to treatment at baseline, compared to TAU.
Participants: 450 adult, pregnant or postpartum women
Intervention: Listening to Women is a mobile phone-based program designed to enhance delivery of Screening, Brief Intervention, and Referral to Treatment (SBIRT), an evidence-based approach for mental health and substance use screening and treatment for perinatal women. This program was created as a result of key informant interviews with obstetric providers and pregnant and postpartum women with opioid use disorders. The program utilizes mobile phone 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.
Design: Specific aim 1: A two arm pilot RCT (N=35) with 2:1 allocation will examine feasibility and preliminary efficacy of LTW, compared to TAU. Specific aim 2: A RCT (N=415) with 1:1 allocation will examine effectiveness of LTW, compared to TAU.
This study is part of the HEAL Initiative (https://heal.nih.gov/).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Listening to Women and Pregnant and Postpartum People | Experimental | 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 | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Listening to Women and Pregnant and Postpartum People | Behavioral | Participants are enrolled in text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to telemedicine mental health and substance use disorder treatment services. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of SBIRT (Specific Aim 1) | 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. | Baseline |
| Screened Positive (Specific Aim 1) | We will compare the proportion of those screening positive that are referred to treatment among those assigned to LTWP, compared to TAU. | Baseline |
| Referred to Treatment (Specific Aim 1) | We 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. | Baseline |
| Treatment Attendance (Specific Aim 1) | Treatment 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) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Screened Positive (Specific Aim 2) | Among those that completed a screen, proportion of participants that screened positive. | Baseline |
| Referred to Treatment (Specific Aim 2) | Among those that completed a screen, proportion of participants that were referred to treatment. |
Not provided
Inclusion Criteria:
1) age 18-41; 2) currently pregnant or postpartum; 3) if pregnant, receiving prenatal care; 4) English fluency; 5) owner of a cell phone with short message service (SMS) text-message based capability; 6) access to Wireless Fidelity (WIFI) and a device to allow audio and video teleconferencing; 7) able to provide informed consent.
Exclusion Criteria: None
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion of SBIRT (Specific Aim 1) | 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. | Posted | Count of Participants | Participants | Baseline |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization etiology unknown | Nervous system disorders | Non-systematic Assessment |
Not provided
Limited data capture of primary outcomes in EHR, particularly for treatment attendance. Treatment may have occurred in other settings not captured by EHR. It is possible that participants in TAU were screened and referred but findings were not recorded in the EHR. The study took place within a single health system and findings may not be generalizable. It is unknown whether the screening completion rates within LTWP would differ in settings where staff do not enroll patients into LTWP.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Constance Guille | The Medical University of South Carolina | 843-792-6489 | guille@musc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2024 | Jul 29, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2024 | Apr 26, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2022 | Nov 20, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D020073 | Gravidity |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D011247 | Pregnancy |
| D012098 | Reproduction |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline |
| Treatment Attendance (Specific Aim 2) | Among those that completed a screen, proportion of participants that attended a mental health or substance use treatment appointment. | Baseline |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Annual Household Income | Count of Participants | Participants |
|
| Rurality of Patient's Residence | Count of Participants | Participants |
|
| Number of Living Children | Median | Inter-Quartile Range | children |
|
| Number of Pregnancies | Median | Inter-Quartile Range | pregnancies |
|
| Currently Pregnant | Count of Participants | Participants |
|
| Number of Weeks Pregnant | Pregnant participants only. | Median | Inter-Quartile Range | weeks |
|
| Number of Months Postpartum | Postpartum participants only. | Median | Inter-Quartile Range | months |
|
| Self-Reported Psychiatric Diagnoses | Count of Participants | Participants |
|
| Self-Reported EPDS Score | Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report screening questionnaire where each item is scored from 0 to 3 with a range of possible scores totaling between 0 and 30. The scores measure the severity of postpartum depression. Higher scores indicate greater severity with a total score higher than 10 indicating possible depression. | Median | Inter-Quartile Range | units on a validated scale |
|
| Self-Reported GAD-7 Score | The Generalized Anxiety Disorder scale-7 (GAD-7) is a 7 item diagnostic tool with each item receiving a score between 0 and 3 measure the severity of anxiety symptoms. The total possible range of scores is between 0 and 21 with 0-4 indicating minimal anxiety, 5-9 indicating mild anxiety, 10-14 indicating moderate anxiety and 15-21 indicating severe anxiety. | Median | Inter-Quartile Range | units on a validated scale |
|
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. |
|
|
| Primary | Screened Positive (Specific Aim 1) | We will compare the proportion of those screening positive that are referred to treatment among those assigned to LTWP, compared to TAU. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Referred to Treatment (Specific Aim 1) | We 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Treatment Attendance (Specific Aim 1) | Treatment 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) | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Screened Positive (Specific Aim 2) | Among those that completed a screen, proportion of participants that screened positive. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Referred to Treatment (Specific Aim 2) | Among those that completed a screen, proportion of participants that were referred to treatment. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Treatment Attendance (Specific Aim 2) | Among those that completed a screen, proportion of participants that attended a mental health or substance use treatment appointment. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 0 |
| 224 |
| 3 |
| 224 |
| 0 |
| 224 |
| EG001 | Treatment as Usual | 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. | 0 | 191 | 3 | 191 | 0 | 191 |
| Cholecystectomy | Hepatobiliary disorders | Non-systematic Assessment | event not related to the intervention |
|
| Percutaneous umbilical blood sampling-Intrauterine Transfusion (PUBS-IUT) | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Mastitis with Abscess | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
| D017584 | Reproductive History |
| D015981 | Epidemiologic Factors |
| D011634 | Public Health |
| D004778 | Environment and Public Health |