Bipolar Disorder
Conditions
Keywords
Bipolar, Substance Use, SUD, Alcohol
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.
Interventions
OTHERSenyo 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age\>=18 years; 2. History of bipolar I disorder, bipolar II disorder, or schizoaffective disorder of the bipolar type. Can be clinical diagnosis 3. Ability to read, write, and understand English; 4. Minimum DAST (1+) or AUDIT-C score (3+) 5. Access and willingness to use a mobile device for asynchronous (text) and synchronous (video) engagement with care; 6. Eligibility determined by ASAM Assessment as completed by a LADC.
Exclusion criteria
1. Inability to actively participate in and learn from psychotherapeutic interaction based on clinical evaluation and clinical judgment; 2. Needing a higher level of mental health care as demonstrated by ASAM\[36\] assessment; - completed by LADC or MD investigators 3. Already admitted into or about to initiate treatment in another addiction treatment program. 4. Currently attending High School. (can be 18 though) 5. Pregnancy confirmed by self-report 6. Inability to provide written informed consent. 7. Inability to understand English. 8. Clinically unstable medical disease. 9. Otherwise excluded for administrative reasons and/or clinician judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) score | 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) | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Substance Craving Scale (BSCS) score | 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. |
| Change in Generalized Anxiety Disorder-7 (GAD-7) score | 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. |
| Change in Patient Health Questionnaire-9 (PHQ-9) score | 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. |
| Change in Patient Mania Questionnaire-9 (PMQ-9) score | 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. |
| 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 | 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. |
Countries
United States
Contacts
CONTACTKelsey Tuen
CONTACTBryce Leatherman
PRINCIPAL_INVESTIGATORMark A. Frye, MD
Mayo Clinic
PRINCIPAL_INVESTIGATORTyler S. Oesterle, MD, MPH
Mayo Clinic
Outcome results
None listed