NCT04630249

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Female
• Age: 18 Years – 41 Years
• Healthy volunteers: Not accepted

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/).

Conditions

• Pregnancy
• Substance Use
• Depression
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	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, referral to telemedicine mental health and substance use disorder treatment services.

Timeline

• Start date: 2020-12-15
• Primary completion: 2023-07-21
• Completion: 2023-07-21
• First posted: 2020-11-16
• Last updated: 2024-10-18
• Results posted: 2024-10-18

Locations

1 site across 1 country: United States