Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07556861

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Chemically-Induced Disorders Mental Disorders Mood Disorders Substance Use (Drugs, Alcohol) Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bryce Leatherman

CONTACT

[email protected]

5074222079

Kelsey Tuen

CONTACT

[email protected]

507-284-2088

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.