Substance Use DisordersNCT06743282
Senyo Health With Substance Use Disorder (SUD) in Primary Care
A study testing Senyo App and Follow-up in people with Substance Use Disorders and Substance Abuse, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Substance Abuse
- What is being tested?
- Senyo App and Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Senyo Health App - Connecting Primary Care to Substance Use Disorder Treatment Using a Telehealth Collaborative Care Platform
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.
- Conditions
- Substance Use Disorders, Substance Abuse
- Being tested
- Senyo App, Follow-up
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senyo AppBehavioural
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-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Senyo | Experimental | Subjects to the Senyo group will begin receiving intervention immediately, and will move to the follow-up phase after 12 weeks. Receives: Behavioral: Senyo App; Behavioral: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start22 Sep 2025
- Primary completion20 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Tyler S. Oesterle, Mayo Clinic
- Investigators
- Tyler Oesterle, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743282
- Sponsor's protocol ID
- 24-007758
- Other IDs
- 1R18HS029774-01
- Status last verified
- May 2026
- First submitted
- 16 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40138685
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senyo Health App - Connecting Primary Care to Substance Use Disorder Treatment Using a Telehealth Collaborative Care Platform
- ClinicalTrials.gov ID
- NCT06743282
- Acronym / sponsor ID
- 24-007758
- Conditions
- Substance Use Disorders, Substance Abuse
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Senyo | Experimental | Behavioral: Senyo App, Behavioral: Follow-upSubjects to the Senyo group will begin receiving intervention immediately, and will move to the follow-up phase after 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senyo AppSubjects 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. | Behavioural | Senyo |
| Follow-upSubjects 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. | Behavioural | Senyo |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 40138685Oesterle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tyler Oesterle principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senyo App and Follow-up in people with Substance Use Disorders and Substance Abuse, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Substance Craving Scale (BSCS) (time frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.