NCT06743282

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

December 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

December 16, 2024

Last Update Submit

February 4, 2026

Conditions

Substance Use DisordersSubstance Abuse

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Generalized Anxiety Disorder-7 (GAD-7)

    Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months

  • Patient Health Questionnaire-9 (PHQ-9)

    Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months

Study Arms (1)

Senyo

EXPERIMENTAL

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

Behavioral: Senyo AppBehavioral: Follow-up

Interventions

Senyo AppBEHAVIORAL

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.

Senyo
Follow-upBEHAVIORAL

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.

Senyo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 40138685DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Tyler Oesterle

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 19, 2024

Study Start

September 22, 2025

Primary Completion (Estimated)

July 20, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)