Senyo Health App - Comorbid Substance Use Disorder Treatment In Bipolar Patients Using A Telehealth Collaborative Care Platform
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- System Usability Scale (SUS) score
Overview
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.
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
- •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
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.
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