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

N/AEnrolling By InvitationNCT06743282

Mayo Clinic60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Substance Use Disorders Substance Abuse

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

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

Secondary Outcomes

Generalized Anxiety Disorder-7 (GAD-7)

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.

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

Patient Health Questionnaire-9 (PHQ-9)

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.

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

Data from ClinicalTrials.gov

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