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Clinical Trials/NCT06743282
NCT06743282
Enrolling By Invitation
Not Applicable

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

Mayo Clinic2 sites in 1 country60 target enrollmentStarted: September 22, 2025Last updated:

Overview

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
60
Locations
2
Primary Endpoint
Brief Substance Craving Scale (BSCS)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

Senyo

Experimental

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

Intervention: Senyo App (Behavioral)

Senyo

Experimental

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

Intervention: Follow-up (Behavioral)

Outcomes

Primary Outcomes

Brief Substance Craving Scale (BSCS)

Time Frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months

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.

Timeline Follow Back

Time Frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months

Timeline Follow Back is an assessment to document substance use over a specific period of time

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tyler S. Oesterle

Principal Investigator

Mayo Clinic

Study Sites (2)

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