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

November 20, 2023 updated by: Constance Guille, Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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=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 Type

Interventional

Enrollment (Actual)

415

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Constance Guille, MD
  • Phone Number: 8437926489
  • Email: guille@musc.edu

Study Locations

    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Listening to Women
This group will receive text-message based SBIRT with phone based assessment and referral to treatment. The SBIRT is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
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.
No Intervention: Treatment as Usual
This group will receive in-person screening and referral to treatment assessment. The same screening tools are used to assess substance abuse and mental health problems in LTW and TAU groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of SBIRT (specific aim 1)
Time Frame: Screening through 3-months post study enrollment
We will compare the proportion of participants that complete a screen for mental health and substance use, the proportion of those screening positive that are referred to treatment, and the proportion of those referred to treatment that had at least one mental health and/or substance use disorder treatment appointment among those assigned to LTW, compared to TAU.
Screening through 3-months post study enrollment
Time to Treatment (specific aim 1)
Time Frame: Screening through 3-months post study enrollment
Time from completion of screening positive to time of first mental health or substance use treatment appointment (if a referral to treatment was appropriate) among those assigned to LTW, compared to TAU.
Screening through 3-months post study enrollment
Attendance to Treatment (specific aim 2)
Time Frame: During pregnancy and the postpartum year
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)
During pregnancy and the postpartum year
Change in Mental Health Symptoms (specific aim 1)
Time Frame: Change from baseline EPDS at 3-months post study enrollment
Mean change in the Edinburgh Postnatal Depression Scale (EPDS) among women referred for treatment. A score of 10 or more on the Edinburgh Postnatal Depression Scale suggests clinically elevated depressive symptoms requiring further evaluation.
Change from baseline EPDS at 3-months post study enrollment
Change in Substance Use (specific aim 1)
Time Frame: Change from baseline substance use at 3-months post study enrollment
Change in substance use frequency and amount as measured by the National Institute on Drug Abuse (NIDA)-Modified Assist among women referred for treatment. A score of 0-3 (0-4 for cannabis) has an indicated response for Brief Education, a score of 4-26 (5-26 for cannabis) has an indicated response for Brief Intervention and a score of 27+ has an indicated response for Brief Intervention (offer options that include treatment).
Change from baseline substance use at 3-months post study enrollment
Change in Maternal Functioning (specific aim 1)
Time Frame: Change from baseline maternal functioning at 3-months post study enrollment
Change in maternal functioning measured by the Medical Outcomes Study Short Form 36 (SF-36v2).
Change from baseline maternal functioning at 3-months post study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment (specific aim 1)
Time Frame: 24 months
The proportion of patients who agree to participate as compared to the total number solicited to enroll for each recruitment approach
24 months
Attrition (specific aim 1)
Time Frame: Through study completion, an average of 3 months
Proportion of study participants that prematurely terminate i.e., do not complete screenings, or are unable to be contacted for referral and/or treatment.
Through study completion, an average of 3 months
Study Retention (specific aim 1)
Time Frame: Through study completion, an average of 3 months
Proportion of study participants that complete all assessment points associated with the protocol.
Through study completion, an average of 3 months
Treatment Attendance (specific aim 1)
Time Frame: Through study completion, an average of 3 months
Proportion of participants that attended a mental health or substance use treatment appointment.
Through study completion, an average of 3 months
Voice Biomarkers (specific aim 1)
Time Frame: Baseline through 3-months post study enrollment
Voice analysis will be completed using an online platform SurveyLex (owned by NeuroLex, Inc.). Among women referred for treatment, we will analyze voice recordings for characteristics (acoustic, linguistic, or meta-feature) which may be compared between those assigned to LTW and those assigned to TAU
Baseline through 3-months post study enrollment
Change in Health-Related Social Needs (specific aim 1)
Time Frame: Change from baseline Health-Related Social Needs use at 3-months post study enrollment
Change in health-related social needs measured by the Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool among those assigned to LTW, compared to TAU
Change from baseline Health-Related Social Needs use at 3-months post study enrollment
Change in Mental Health Symptoms-Depression (specific aim 2)
Time Frame: Change from baseline mental health symptoms (depression) at 3-months post study enrollment
Among women referred for treatment, we will compare the mean change in the Edinburgh Postnatal Depression Scale (EPDS) among those assigned to LTW, compared to TAU. A score of 10 or more on the Edinburgh Postnatal Depression Scale suggests clinically elevated depressive symptoms requiring further evaluation. A higher score on the EPDS is a worse outcome.
Change from baseline mental health symptoms (depression) at 3-months post study enrollment
Change in Mental Health Symptoms-Anxiety (specific aim 2)
Time Frame: Change from baseline mental health symptoms (anxiety) at 3-months post study enrollment
Among women referred for treatment, we will compare the mean change in the Generalized Anxiety Disorder-7 (GAD-7) among those assigned to LTW, compared to TAU. A score of 1-4 on the GAD-7 indicates minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety and 15-21 is severe anxiety. A higher score on the GAD-7 is a worse outcome.
Change from baseline mental health symptoms (anxiety) at 3-months post study enrollment
Change in Mental Health Symptoms-Suicidal Ideation (specific aim 2)
Time Frame: Change from baseline mental health symptoms (suicidal ideation) at 3-months post study enrollment
Among women referred for treatment, we will compare the mean change in the Columbia Suicide Severity Rating Scale (CSSRS) among those assigned to LTW, compared to TAU. There are no specified clinical cutoffs due to the binary nature of the responses to items.
Change from baseline mental health symptoms (suicidal ideation) at 3-months post study enrollment
Change in Substance Use-NIDA Modified Assist (specific aim 2)
Time Frame: Change from baseline substance use at 3-months post study enrollment
Among women referred for treatment, we will compare change in substance use frequency and amount as measured by the NIDA-Modified Assist among those assigned to LTW, compared to TAU. A score of 0-3 (0-4 for cannabis) has an indicated response for Brief Education, a score of 4-26 (5-26 for cannabis) has an indicated response for Brief Intervention and a score of 27+ has an indicated response for Brief Intervention (offer options that include treatment).
Change from baseline substance use at 3-months post study enrollment
Change in Substance Use-Timeline Follow Back (specific aim 2)
Time Frame: Change from baseline substance use at 3-months post study enrollment
Among women referred for treatment, we will compare change in substance use frequency and amount as measured by Timeline Follow-Back (TLFB) among those assigned to LTW, compared to TAU.
Change from baseline substance use at 3-months post study enrollment
Change in Maternal Functioning (specific aim 2)
Time Frame: Change from baseline maternal functioning at 3-months post study enrollment
Among women referred for treatment, we will compare the change in maternal functioning measured by the Medical Outcomes Study Short Form 36 (SF-36v2) among those assigned to LTW, compared to TAU.
Change from baseline maternal functioning at 3-months post study enrollment
Change in Health-Related Social Needs
Time Frame: Change from baseline Health-Related Social Needs use at 3-months post study enrollment
Among women referred for treatment, we will compare the change in health-related social needs measured by the Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool among those assigned to LTW, compared to TAU.
Change from baseline Health-Related Social Needs use at 3-months post study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

July 21, 2023

Study Completion (Actual)

July 21, 2023

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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