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

Not Applicable

• Conditions: Substance Use Disorders; Substance Abuse

• Registration Number: NCT06743282
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Study Start: 2025-06-15
• Primary Completion: 2027-07-20
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Brief Substance Craving Scale (BSCS)	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.

Secondary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder-7 (GAD-7)	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.
Patient Health Questionnaire-9 (PHQ-9)	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.

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States