Anxiety, Depression, Pregnancy, Substance Use
Conditions
Keywords
Pregnancy, Depression, Substance Use, Anxiety
Brief summary
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.
Detailed description
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/).
Interventions
BEHAVIORALListening 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, referral to telemedicine mental health and substance use disorder treatment services.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of SBIRT (Specific Aim 1) | Baseline | 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. |
| Screened Positive (Specific Aim 1) | Baseline | We will compare the proportion of those screening positive that are referred to treatment among those assigned to LTWP, compared to TAU. |
| Referred to Treatment (Specific Aim 1) | Baseline | 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. |
| Treatment Attendance (Specific Aim 1) | Baseline | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Referred to Treatment (Specific Aim 2) | Baseline | Among those that completed a screen, proportion of participants that were referred to treatment. |
| Treatment Attendance (Specific Aim 2) | Baseline | Among those that completed a screen, proportion of participants that attended a mental health or substance use treatment appointment. |
| Screened Positive (Specific Aim 2) | Baseline | Among those that completed a screen, proportion of participants that screened positive. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 224 |
| 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. | 191 |
| Total | 415 |
Baseline characteristics
| Characteristic | Listening to Women and Pregnant and Postpartum People | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 31 years | 31 years | 31 years |
| Annual Household Income $25,000 per year or more | 178 Participants | 338 Participants | 160 Participants |
| Annual Household Income Under $25,000 per year | 46 Participants | 77 Participants | 31 Participants |
| Currently Pregnant | 102 Participants | 187 Participants | 85 Participants |
| Number of Living Children | 1 children | 1 children | 1 children |
| Number of Months Postpartum | 2.0 months | 2.0 months | 2.0 months |
| Number of Pregnancies | 2 pregnancies | 2 pregnancies | 2 pregnancies |
| Number of Weeks Pregnant | 28.0 weeks | 28.0 weeks | 28.0 weeks |
| Race/Ethnicity, Customized Hispanic | 12 Participants | 20 Participants | 8 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 70 Participants | 141 Participants | 71 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 135 Participants | 245 Participants | 110 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 9 Participants | 2 Participants |
| Rurality of Patient's Residence Data Missing | 14 Participants | 18 Participants | 4 Participants |
| Rurality of Patient's Residence Partially Rural | 154 Participants | 295 Participants | 141 Participants |
| Rurality of Patient's Residence Rural | 14 Participants | 32 Participants | 18 Participants |
| Rurality of Patient's Residence Urban | 42 Participants | 70 Participants | 28 Participants |
| Self-Reported EPDS Score | 5.0 units on a validated scale | 5.0 units on a validated scale | 6.0 units on a validated scale |
| Self-Reported GAD-7 Score | 3.0 units on a validated scale | 3.0 units on a validated scale | 3.0 units on a validated scale |
| Self-Reported Psychiatric Diagnoses Anxiety Disorder | 67 Participants | 119 Participants | 52 Participants |
| Self-Reported Psychiatric Diagnoses Mood Disorder | 35 Participants | 62 Participants | 27 Participants |
| Self-Reported Psychiatric Diagnoses None | 141 Participants | 270 Participants | 129 Participants |
| Self-Reported Psychiatric Diagnoses Psychotic Disorder | 0 Participants | 0 Participants | 0 Participants |
| Self-Reported Psychiatric Diagnoses Substance Use Disorder | 21 Participants | 30 Participants | 9 Participants |
| Sex: Female, Male Female | 224 Participants | 415 Participants | 191 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 224 | 0 / 191 |
| other Total, other adverse events | 0 / 224 | 0 / 191 |
| serious Total, serious adverse events | 3 / 224 | 3 / 191 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Listening to Women and Pregnant and Postpartum People | Completion of SBIRT (Specific Aim 1) | 221 Participants |
| Usual Care | Completion of SBIRT (Specific Aim 1) | 63 Participants |
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Listening to Women and Pregnant and Postpartum People | Referred to Treatment (Specific Aim 1) | 31 Participants |
| Usual Care | Referred to Treatment (Specific Aim 1) | 2 Participants |
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Listening to Women and Pregnant and Postpartum People | Screened Positive (Specific Aim 1) | 121 Participants |
| Usual Care | Screened Positive (Specific Aim 1) | 11 Participants |
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)
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Listening to Women and Pregnant and Postpartum People | Treatment Attendance (Specific Aim 1) | 20 Participants |
| Usual Care | Treatment Attendance (Specific Aim 1) | 1 Participants |
Secondary
Referred to Treatment (Specific Aim 2)
Among those that completed a screen, proportion of participants that were referred to treatment.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Listening to Women and Pregnant and Postpartum People | Referred to Treatment (Specific Aim 2) | 31 Participants |
| Usual Care | Referred to Treatment (Specific Aim 2) | 2 Participants |
Secondary
Screened Positive (Specific Aim 2)
Among those that completed a screen, proportion of participants that screened positive.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Listening to Women and Pregnant and Postpartum People | Screened Positive (Specific Aim 2) | 121 Participants |
| Usual Care | Screened Positive (Specific Aim 2) | 11 Participants |
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Listening to Women and Pregnant and Postpartum People | Treatment Attendance (Specific Aim 2) | 20 Participants |
| Usual Care | Treatment Attendance (Specific Aim 2) | 1 Participants |