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

NCT07556861 | Not Yet Recruiting

• 1 other identifier: 25-013880
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder; Substance Use (Drugs, Alcohol)

Keywords

Bipolar; Substance Use; SUD; Alcohol

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (5)

• Change in Brief Substance Craving Scale (BSCS) score

  Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months

• Change in Generalized Anxiety Disorder-7 (GAD-7) score

  Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months

• Change in Patient Health Questionnaire-9 (PHQ-9) score

  Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months

• Change in Patient Mania Questionnaire-9 (PMQ-9) score

  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

  Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 1 year

Study Arms (1)

Senyo Health app

EXPERIMENTAL

Patients will utilize the Senyo Health app daily, for 12 weeks

Other: Senyo Health App

Interventions

Senyo Health App OTHER

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.

Senyo Health app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Bipolar Disorder; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Mark A. Frye, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Tyler S. Oesterle, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Tuen

CONTACT

507-284-2088; tuen.kelsey@mayo.edu

Bryce Leatherman

CONTACT

5074222079; leatherman.bryce@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): May 16, 2026
• Primary Completion (Estimated): January 20, 2029
• Study Completion (Estimated): January 20, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)