- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Constance Guille, MD
- Phone Number: 8437926489
- Email: guille@musc.edu
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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.
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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.
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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
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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.
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Screening through 3-months post study enrollment
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Time to Treatment (specific aim 1)
Time Frame: Screening through 3-months post study enrollment
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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.
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Screening through 3-months post study enrollment
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Attendance to Treatment (specific aim 2)
Time Frame: During pregnancy and the postpartum year
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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)
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During pregnancy and the postpartum year
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Change in Mental Health Symptoms (specific aim 1)
Time Frame: Change from baseline EPDS at 3-months post study enrollment
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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.
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Change from baseline EPDS at 3-months post study enrollment
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Change in Substance Use (specific aim 1)
Time Frame: Change from baseline substance use at 3-months post study enrollment
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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).
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Change from baseline substance use at 3-months post study enrollment
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Change in Maternal Functioning (specific aim 1)
Time Frame: Change from baseline maternal functioning at 3-months post study enrollment
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Change in maternal functioning measured by the Medical Outcomes Study Short Form 36 (SF-36v2).
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Change from baseline maternal functioning at 3-months post study enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment (specific aim 1)
Time Frame: 24 months
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The proportion of patients who agree to participate as compared to the total number solicited to enroll for each recruitment approach
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24 months
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Attrition (specific aim 1)
Time Frame: Through study completion, an average of 3 months
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Proportion of study participants that prematurely terminate i.e., do not complete screenings, or are unable to be contacted for referral and/or treatment.
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Through study completion, an average of 3 months
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Study Retention (specific aim 1)
Time Frame: Through study completion, an average of 3 months
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Proportion of study participants that complete all assessment points associated with the protocol.
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Through study completion, an average of 3 months
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Treatment Attendance (specific aim 1)
Time Frame: Through study completion, an average of 3 months
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Proportion of participants that attended a mental health or substance use treatment appointment.
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Through study completion, an average of 3 months
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Voice Biomarkers (specific aim 1)
Time Frame: Baseline through 3-months post study enrollment
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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
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Baseline through 3-months post study enrollment
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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
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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
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Change from baseline Health-Related Social Needs use at 3-months post study enrollment
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Change in Mental Health Symptoms-Depression (specific aim 2)
Time Frame: Change from baseline mental health symptoms (depression) at 3-months post study enrollment
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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.
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Change from baseline mental health symptoms (depression) at 3-months post study enrollment
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Change in Mental Health Symptoms-Anxiety (specific aim 2)
Time Frame: Change from baseline mental health symptoms (anxiety) at 3-months post study enrollment
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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.
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Change from baseline mental health symptoms (anxiety) at 3-months post study enrollment
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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
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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.
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Change from baseline mental health symptoms (suicidal ideation) at 3-months post study enrollment
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Change in Substance Use-NIDA Modified Assist (specific aim 2)
Time Frame: Change from baseline substance use at 3-months post study enrollment
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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).
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Change from baseline substance use at 3-months post study enrollment
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Change in Substance Use-Timeline Follow Back (specific aim 2)
Time Frame: Change from baseline substance use at 3-months post study enrollment
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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.
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Change from baseline substance use at 3-months post study enrollment
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Change in Maternal Functioning (specific aim 2)
Time Frame: Change from baseline maternal functioning at 3-months post study enrollment
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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.
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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.
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Change from baseline Health-Related Social Needs use at 3-months post study enrollment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00103742
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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