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

Status Completed

Clinical Trial 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 as well as reduction in mental health and substance use at 1 and 3 months post-study enrollment, 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 attendance to treatment as well as reduction in mental health and substance use at 1 and 3 months post-study enrollment, compared to TAU.

Clinical Trial 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=100) with 2:1 allocation will examine feasibility and preliminary efficacy of LTW, compared to TAU. Specific aim 2: A RCT (N=350) with 2:1 allocation will examine effectiveness of LTW, compared to TAU. As of the approval of amendment #12 the allocation will switch to 1(LTW):2(TAU) for specific aim 2. This study is part of the HEAL Initiative (https://heal.nih.gov/). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04630249
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	N/A
Start date	December 15, 2020
Completion date	July 21, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.