Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Substance Use; Depression; Anxiety; Pregnancy

Treatments: Behavioral: Listening to Women and Pregnant and Postpartum People

Study type: Interventional

Funder types: Other

Identifiers

NCT04630249

00103742

Details and patient eligibility

About

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.

Full 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/).

Enrollment: 415 patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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415 participants in 2 patient groups

Listening to Women and Pregnant and Postpartum People

Experimental group

Description:

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:

Behavioral: Listening to Women and Pregnant and Postpartum People

Usual Care

No Intervention group

Description:

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.