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

Senyo Health App - Connecting Primary Care to Substance Use Disorder Treatment Using a Telehealth Collaborative Care Platform

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06743282
Enrollment
60
Registered
2024-12-19
Start date
2025-09-22
Completion date
2027-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Abuse, Substance Use Disorders

Brief summary

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.

Interventions

BEHAVIORALSenyo 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.

BEHAVIORALFollow-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.

Sponsors

Mayo Clinic
Lead SponsorOTHER
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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. Currently attending High School.

Design outcomes

Primary

MeasureTime frameDescription
Brief Substance Craving Scale (BSCS)Baseline, weekly for 12 weeks, 4 months, 5 months, 6 monthsThe Brief Substance Craving Scale is a 16 item, self-report instrument that assesses craving for substances of abuse over a 24 hour period. Intensity and frequency of craving are recorded on a five-point Likert scale, with 0 = Not at all, 1 = Slight, 2 = Moderate, 3 = Considerable, and 4 = Extreme.
Timeline Follow BackBaseline, weekly for 12 weeks, 4 months, 5 months, 6 monthsTimeline Follow Back is an assessment to document substance use over a specific period of time

Secondary

MeasureTime frameDescription
Generalized Anxiety Disorder-7 (GAD-7)Baseline, weekly for 12 weeks, 4 months, 5 months, 6 monthsThe General Anxiety Disorder 7-item (GAD 7) scale to assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.
Patient Health Questionnaire-9 (PHQ-9)Baseline, weekly for 12 weeks, 4 months, 5 months, 6 monthsThe Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTyler Oesterle

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026