Bipolar DisorderNCT07556861
Senyo Health App - Comorbid Alcohol Use Disorder Treatment in Individuals With Bipolar Disorder Using a Telehealth Collaborative Care Platform
A study testing Senyo Health App in people with Bipolar Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of a digital integrated behavioral health (IBH) platform in improving alcohol use outcomes, including treatment retention and substance use frequency and severity in patients with Bipolar Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Senyo Health App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2026to 20 Jan 2029
- 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
- Age>=18 years;
- History of bipolar I disorder, bipolar II disorder, or schizoaffective disorder of the bipolar type. Can be clinical diagnosis
- Ability to read, write, and understand English;
- Minimum DAST (1+) or AUDIT-C score (3+)
- Access and willingness to use a mobile device for asynchronous (text) and synchronous (video) engagement with care;
- Eligibility determined by ASAM Assessment as completed by a LADC.
Who cannot join
- 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 ASAM[36] assessment; - completed by LADC or MD investigators
- Already admitted into or about to initiate treatment in another addiction treatment program.
- Currently attending High School. (can be 18 though)
- Pregnancy confirmed by self-report
- Inability to provide written informed consent.
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- Inability to understand English.
- Clinically unstable medical disease.
- Otherwise excluded for administrative reasons and/or clinician judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The purpose of this study is to examine the effectiveness of a digital integrated behavioral health (IBH) platform in improving alcohol use outcomes, including treatment retention and substance use frequency and severity in patients with Bipolar Disorder.
- Conditions
- Bipolar Disorder
- Being tested
- Senyo Health App
- Keywords
- Bipolar, Substance Use, SUD, Alcohol
- Medical subject headings
- Bipolar Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senyo Health AppOther
The Senyo Health app includes asynchronous cognitive behavioral therapy (CBT) modules, contingency management, behavioral activation, and an interface to interact with the care manager for support in treating the comorbidities of bipolar disorder and substance use disorder.
Patients will engage with the app daily and have weekly check-in visits with the care manager. After the initial 12 week intervention phase, subjects will be followed for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Senyo Health app | Experimental | Patients will utilize the Senyo Health app daily, for 12 weeks Receives: Other: Senyo Health App |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS) score
The System Usability Scale (SUS) is a 10-item scale to assess usability of the app. Statements are rated on a 5 point scale where 1 = 'strongly disagree' and 5 = 'strongly agree'. Higher total scores indicates higher perception of app usability by patients.
Measured: 12 weeks
Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) is a 12 question survey that assesses acceptability, appropriateness, and feasibility of the app. Responses are on a 5 point scale where 1 = 'completely disagree' and 5 = 'completely agree'. Higher scores indicate greater acceptance of the app.
Measured: 12 weeks
Intervention Appropriatness Measure
The Intervention Appropriateness Measure (IAM) is a tool consisting of 4 items designed to assess the suitability and relevance of an intervention without specifying a particular purpose, person, or situation. It aims to provide a generalizable assessment of the appropriateness of interventions by capturing individual perspectives on the alignment of the intervention with professional values and perceived efficacy in meeting patient needs.
Measured: 12 weeks
Feasibility of Intervention Measure
Measuring the feasibility or extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting.
Measured: 12 weeks
Timeline Follow Back
Gather the history of substance use, such as how much you used each day.
Measured: Baseline, Weekly for 12 weeks, then monthly for 3 months. 9 months and 1 year.
Secondary outcomes (5)
Change in Brief Substance Craving Scale (BSCS) score
The Brief Substance Craving Scale (BSCS) survey assesses the intensity, frequency, number of times, and length of time a subject craves a substance over a 24 hour period. The statements are rated on a 5 point scale, where 0 = 'never/none' and 4 = 'extreme/constant'. Higher overall scores indicates a greater deal of craving for substances of abuse.
Measured: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months
Change in Generalized Anxiety Disorder-7 (GAD-7) score
The General Anxiety Disorder is a 7-item 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, 9 months, 12 months
Change in Patient Health Questionnaire-9 (PHQ-9) score
The Patient Health Questionnaire 9-item (PHQ-9) scale is 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, 9 months, 12 months
Change in Patient Mania Questionnaire-9 (PMQ-9) score
The Patient Mania Questionnaire-9 (PMQ-9) questionnaire is a 9 item scale to assess symptoms of mania. Statements are rated on a 4 point scale where 0 = 'not at all' and 3 = 'nearly every day'. Higher overall scores indicate a greater presence of mania type symptoms.
Measured: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months
Change in Brief Assessment of Recovery Capital (BARC-10) score
The Brief Assessment of Recovery Capital (BARC-10) survey is a 10 item questionnaire used to assess the tools and resources a patient has available to support recovery. Statements are rated on a 6 point scale, where 1 = 'strongly disagree' and 6 = 'strongly agree'. Higher scores indicate a greater level of support available to the patient.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start16 Sep 2026 (estimated)
- Primary completion20 Jan 2029 (estimated)
- Study completion20 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Frye, Mayo Clinic
- Investigators
- Mark A. Frye, MD, Principal investigator, Mayo ClinicTyler S. Oesterle, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556861
- Sponsor's protocol ID
- 25-013880
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senyo Health App - Comorbid Alcohol Use Disorder Treatment in Individuals With Bipolar Disorder Using a Telehealth Collaborative Care Platform
- ClinicalTrials.gov ID
- NCT07556861
- Acronym / sponsor ID
- 25-013880
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar, Substance Use, SUD, Alcohol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 20 Jan 2029 (estimated)
- Study completion
- 20 Jan 2029 (estimated)
- First posted
- 29 Apr 2026 (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 effectiveness of a digital integrated behavioral health (IBH) platform in improving alcohol use outcomes, including treatment retention and substance use frequency and severity in patients with Bipolar Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Senyo Health app | Experimental | Other: Senyo Health AppPatients will utilize the Senyo Health app daily, for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>=18 years;
- History of bipolar I disorder, bipolar II disorder, or schizoaffective disorder of the bipolar type. Can be clinical diagnosis
- Ability to read, write, and understand English;
- Minimum DAST (1+) or AUDIT-C score (3+)
- Access and willingness to use a mobile device for asynchronous (text) and synchronous (video) engagement with care;
Key exclusion criteria (9 listed)
- 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 ASAM[36] assessment; - completed by LADC or MD investigators
- Already admitted into or about to initiate treatment in another addiction treatment program.
- Currently attending High School. (can be 18 though)
- Pregnancy confirmed by self-report
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 Health AppThe Senyo Health app includes asynchronous cognitive behavioral therapy (CBT) modules, contingency management, behavioral activation, and an interface to interact with the care manager for support in treating the comorbidities of bipolar disorder and substance use disorder. Patients will engage with the app daily and have weekly check-in visits with the care manager. After the initial 12 week intervention phase, subjects will be followed for 1 year. | Other | Senyo Health app |
Primary outcome
System Usability Scale (SUS) score
Time frame: 12 weeks
The System Usability Scale (SUS) is a 10-item scale to assess usability of the app. Statements are rated on a 5 point scale where 1 = 'strongly disagree' and 5 = 'strongly agree'. Higher total scores indicates higher perception of app usability by patients.
Acceptability of Intervention Measure (AIM)
Time frame: 12 weeks
The Acceptability of Intervention Measure (AIM) is a 12 question survey that assesses acceptability, appropriateness, and feasibility of the app. Responses are on a 5 point scale where 1 = 'completely disagree' and 5 = 'completely agree'. Higher scores indicate greater acceptance of the app.
Intervention Appropriatness Measure
Time frame: 12 weeks
The Intervention Appropriateness Measure (IAM) is a tool consisting of 4 items designed to assess the suitability and relevance of an intervention without specifying a particular purpose, person, or situation. It aims to provide a generalizable assessment of the appropriateness of interventions by capturing individual perspectives on the alignment of the intervention with professional values and perceived efficacy in meeting patient needs.
Feasibility of Intervention Measure
Time frame: 12 weeks
Measuring the feasibility or extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting.
Timeline Follow Back
Time frame: Baseline, Weekly for 12 weeks, then monthly for 3 months. 9 months and 1 year.
Gather the history of substance use, such as how much you used each day.
5 secondary outcomes
Change in Brief Substance Craving Scale (BSCS) score
Time frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months
Change in Generalized Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months
Change in Patient Mania Questionnaire-9 (PMQ-9) score
Time frame: Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months
Change in Brief Assessment of Recovery Capital (BARC-10) score
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 1 year
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 31 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Mark A. Frye, MD principal investigator
Mayo Clinic
Tyler S. Oesterle, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senyo Health App in people with Bipolar Disorder, run by Mayo Clinic at 1 site 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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Kelsey Tuen (507-284-2088, tuen.kelsey@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) score (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.