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Not yet recruiting NCT07556861

Senyo Health App - Comorbid Alcohol Use Disorder Treatment in Individuals With Bipolar Disorder Using a Telehealth Collaborative Care Platform

No phase Interventional Bipolar Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Senyo Health App.
Who it may be relevant to
Registry conditions: Bipolar Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • System Usability Scale (SUS) score [Time frame: 12 weeks]
  • Acceptability of Intervention Measure (AIM) [Time frame: 12 weeks]
  • Intervention Appropriatness Measure [Time frame: 12 weeks]
  • Feasibility of Intervention Measure [Time frame: 12 weeks]
  • Timeline Follow Back [Time frame: Baseline, Weekly for 12 weeks, then monthly for 3 months. 9 months and 1 year.]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Inability to understand English.
  • Clinically unstable medical disease.
  • Otherwise excluded for administrative reasons and/or clinician judgment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07556861 · 25-013880

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗