A Study Of Senyo Health With Comorbid Alcohol Use Disorder Treatment In Bipolar Patients

April 22, 2026 updated by: Mark Frye, Mayo Clinic

Senyo Health App - Comorbid Substance Use Disorder Treatment In Bipolar Patients Using A Telehealth Collaborative Care Platform

The purpose of this study is to examine the effectiveness of a digital integrated behavioral health (IBH) platform in improving substance use outcomes, including treatment retention and substance use frequency and severity in patients with Bipolar Disorder.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of bipolar I disorder, bipolar II disorder, or schizoaffective disorder of the bipolar type
  • Alcohol use disorder.
  • 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

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 ASAM[36] assessment;
  • Decline to answer suicidality questions;
  • Already admitted into or about to initiate treatment in another addiction treatment program.
  • Currently attending High School.
  • Pregnancy confirmed by self-report

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Senyo Health app
Patients will utilize the Senyo Health app daily, for 12 weeks
Other: Senyo Health App

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
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
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.
Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Mark A. Frye, MD, Mayo Clinic
  • Principal Investigator: Tyler S. Oesterle, MD, MPH, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 16, 2026

Primary Completion (Estimated)

January 20, 2029

Study Completion (Estimated)

January 20, 2029

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-013880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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