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Completed

NCT Number: NCT04630249

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

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.

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Key information

Conditions

Pregnancy Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Substance Use Substance-Related Disorders

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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/).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

None

Treatment and study plan

Listening to Women and Pregnant and Postpartum People

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Screened Positive (Specific Aim 2)

    Time frame: Baseline

    Among those that completed a screen, proportion of participants that screened positive.

  2. Referred to Treatment (Specific Aim 2)

    Time frame: Baseline

    Among those that completed a screen, proportion of participants that were referred to treatment.

  3. Treatment Attendance (Specific Aim 2)

    Time frame: Baseline

    Among those that completed a screen, proportion of participants that attended a mental health or substance use treatment appointment.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2020
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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