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

Study Overview
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Brief Summary
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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.

Detailed Description
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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/).

Official Title
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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

Conditions
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Pregnancy, Substance Use, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Listening to Women


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Listening to Women<br>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. | Behavioral: Listening to Women<br>* 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.<br>|
| No Intervention: Treatment as Usual<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of SBIRT (specific aim 1) | 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 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 | 
| Change in Mental Health Symptoms (specific aim 1) | 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) | 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) | 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 | 
| Attendance to Treatment (specific aim 2) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment (specific aim 1) | 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) | 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) | 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) | Proportion of participants that attended a mental health or substance use treatment appointment. | Through study completion, an average of 3 months | 
| Change in Health-Related Social Needs (specific aim 1) | 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 | 
| Voice Biomarkers (specific aim 1) | 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 Mental Health Symptoms-Depression (specific aim 2) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Anxiety, Depression, Substance Use