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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senyo Health app | Experimental | Patients will utilize the Senyo Health app daily, for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale (SUS) score | 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. | 12 weeks |
| Acceptability of Intervention Measure (AIM) | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Substance Craving Scale (BSCS) score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Tuen | Contact | 507-284-2088 | tuen.kelsey@mayo.edu | |
| Bryce Leatherman | Contact | 5074222079 | leatherman.bryce@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark A. Frye, MD | Mayo Clinic | Principal Investigator |
| Tyler S. Oesterle, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months |
| Change in Generalized Anxiety Disorder-7 (GAD-7) score | 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. | Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months |
| Change in Patient Health Questionnaire-9 (PHQ-9) score | 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. | Baseline, weekly for 12 weeks, 4 months, 5 months, 6 months, 9 months, 12 months |
| Change in Patient Mania Questionnaire-9 (PMQ-9) score | 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. | 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 | 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. | Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 1 year |