Clinical trial NCT04630249: Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Substance Use
Depression
Anxiety
Keywords: Pregnancy
Depression
Substance Use
Anxiety
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 415
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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/).

Eligibility 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

Primary outcomes:
measure: Completion of SBIRT (Specific Aim 1)
timeFrame: Baseline
measure: Screened Positive (Specific Aim 1)
timeFrame: Baseline
measure: Referred to Treatment (Specific Aim 1)
timeFrame: Baseline
measure: Treatment Attendance (Specific Aim 1)
timeFrame: Baseline
Secondary outcomes:
measure: Screened Positive (Specific Aim 2)
timeFrame: Baseline
measure: Referred to Treatment (Specific Aim 2)
timeFrame: Baseline
measure: Treatment Attendance (Specific Aim 2)
timeFrame: Baseline
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: