Senyo Health App - Comorbid Alcohol Use Disorder Treatment in Individuals With Bipolar Disorder Using a Telehealth Collaborative Care Platform
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- System Usability Scale (SUS) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Senyo Health app
Patients will utilize the Senyo Health app daily, for 12 weeks
干预措施: Senyo Health App (Other)
结局指标
主要结局
System Usability Scale (SUS) score
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)