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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Substance Use Disorders; Substance Abuse
• Intervention / Treatment: Behavioral: Senyo App; Behavioral: Follow-up

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Substance Craving Scale (BSCS)	The 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.	Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months
Timeline Follow Back	Timeline Follow Back is an assessment to document substance use over a specific period of time	Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder-7 (GAD-7)	The 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.	Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months
Patient Health Questionnaire-9 (PHQ-9)	The 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.	Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Tyler Oesterle, Mayo Clinic

Publications and helpful links

General Publications

• Oesterle TS, Bormann NL, Paul MM, Breitinger SA, Lai B, Smith JL, Stoppel CJ, Arndt S, Williams MD. Treatment of Substance Use Disorders With a Mobile Phone App Within Rural Collaborative Care Management (Senyo Health): Protocol for a Mixed Methods Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 26;14:e65693. doi: 10.2196/65693.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Organization and Administration; Health Services Administration; Appointments and Schedules; Waiting Lists
• Other Study ID Numbers: 24-007758; 1R18HS029774-01 (U.S. AHRQ Grant/Contract)

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
• product manufactured in and exported from the U.S.: No