Senyo Health With Substance Use Disorder (SUD) in Primary Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2027-12-31

Brief Summary

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The purpose of this study is to examine the barriers, facilitators, and optimal processes for implementing a digitally enhanced screening, brief intervention, and referral to treatment (SBIRT) model for Substance Use Disorder SUD treatment among Mayo primary care clinics.

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Detailed Description

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Conditions

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Substance Use Disorders Substance Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Senyo

Subjects randomized to the Senyo group will begin receiving intervention immediately, and will move to the follow-up phase after 12 weeks.

Group Type EXPERIMENTAL

Senyo App

Intervention Type BEHAVIORAL

Subjects will engage with the Senyo Health platform for 12 weeks to deliver Integrated Behavioral Healthcare (IBH) treatment. The Senyo Health platform consists of asynchronous cognitive behavioral therapy modules and weekly check-ins with the IBH care manager. Subjects will also complete a monthly urine test for substances, the Timeline Follow Back (TLFB) to gather substance abuse history, and complete weekly questionnaires.

Follow-up

Intervention Type BEHAVIORAL

Subjects will have monthly check-in meetings with the Integrated Behavioral Healthcare manager, complete monthly urine tests for substance use, the Timeline Follow Back (TLFB) to gather substance abuse history, and complete monthly questionnaires.

Waitlist

Subjects randomized to the waitlist group will serve as a control group and receive intervention after 12 weeks on the waitlist.

Group Type ACTIVE_COMPARATOR

Waitlist

Intervention Type BEHAVIORAL

Subjects will have monthly check-in meetings with the Integrated Behavioral Healthcare manager, complete monthly urine tests for substance use, the Timeline Follow Back (TLFB) to gather substance abuse history, and complete baseline questionnaires.

Senyo App

Intervention Type BEHAVIORAL

Subjects will engage with the Senyo Health platform for 12 weeks to deliver Integrated Behavioral Healthcare (IBH) treatment. The Senyo Health platform consists of asynchronous cognitive behavioral therapy modules and weekly check-ins with the IBH care manager. Subjects will also complete a monthly urine test for substances, the Timeline Follow Back (TLFB) to gather substance abuse history, and complete weekly questionnaires.

Interventions

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Waitlist

Subjects will have monthly check-in meetings with the Integrated Behavioral Healthcare manager, complete monthly urine tests for substance use, the Timeline Follow Back (TLFB) to gather substance abuse history, and complete baseline questionnaires.

Intervention Type BEHAVIORAL

Senyo App

Subjects will engage with the Senyo Health platform for 12 weeks to deliver Integrated Behavioral Healthcare (IBH) treatment. The Senyo Health platform consists of asynchronous cognitive behavioral therapy modules and weekly check-ins with the IBH care manager. Subjects will also complete a monthly urine test for substances, the Timeline Follow Back (TLFB) to gather substance abuse history, and complete weekly questionnaires.

Intervention Type BEHAVIORAL

Follow-up

Subjects will have monthly check-in meetings with the Integrated Behavioral Healthcare manager, complete monthly urine tests for substance use, the Timeline Follow Back (TLFB) to gather substance abuse history, and complete monthly questionnaires.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Ability to read, write, and understand English
* Minimum DAST (1+), audit-C score (3+)
* Access and willingness to use a mobile device for asynchronous (text) and synchronous (video) engagement with care.
* Access to or willingness to obtain a Primary care provider at a participating Mayo Clinic site;
* Eligibility determined by ASAM Assessment

Exclusion Criteria

* Diagnosed personality pathology as the primary presenting concern based on clinical judgment, severe cognitive impairment (e.g., intellectual disability or dementia), or psychosis
* Inability to actively participate in and learn from psychotherapeutic interaction based on clinical evaluation and clinical judgment
* Needing a higher level of mental health care as demonstrated by ASAM32 assessment.
* Decline to answer suicidality questions.
* Already admitted into or about to initiate treatment in another addiction treatment program.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No