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OpenTrials
Enrolling by Invitation

NCT Number: NCT06743282

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

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.

Enrolling by Invitation

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance Abuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Senyo App

Behavioral

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.

follow-up

Behavioral

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 outcomes

  1. 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.

  2. 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

  1. Generalized Anxiety Disorder-7 (GAD-7)

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

    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.

  2. Patient Health Questionnaire-9 (PHQ-9)

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

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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