Pilot RCT of Remote Mental Health and Substance Use Screening, Brief Intervention and Referral to Treatment (SBIRT), Compared to In-Person SBIRT for Peripartum Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 415
- Locations
- 1
- Primary Endpoint
- Completion of SBIRT (Specific Aim 1)
Study Overview
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/).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 41 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- Not provided
Arms & Interventions
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.
Intervention: Listening to Women and Pregnant and Postpartum People (Behavioral)
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.
Outcomes
Primary Outcomes
Completion of SBIRT (Specific Aim 1)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Screened Positive (Specific Aim 2)(Baseline)
- Referred to Treatment (Specific Aim 2)(Baseline)
- Treatment Attendance (Specific Aim 2)(Baseline)
Investigators
Constance Guille
Professor
Medical University of South Carolina