Senyo Health App - Comorbid Alcohol Use Disorder Treatment in Individuals With Bipolar Disorder Using a Telehealth Collaborative Care Platform
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- System Usability Scale (SUS) score
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Senyo Health app
Patients will utilize the Senyo Health app daily, for 12 weeks
Intervention: Senyo Health App (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Mark Frye
Principal Investigator
Mayo Clinic