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Enrolling by invitation NCT06743282

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

No phase Interventional Substance Use Disorders Substance Abuse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Senyo App, Follow-up.
Who it may be relevant to
Registry conditions: Substance Use Disorders, Substance Abuse. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Brief Substance Craving Scale (BSCS) [Time frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months]
  • Timeline Follow Back [Time frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months]
Secondary outcome measures (2)
  • Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months]
  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Rochester — Rochester

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. PMID 40138685

Identifiers

NCT: NCT06743282 · 24-007758 · 1R18HS029774-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗