Automated Reinforcement Management System (ARMS): Phase I Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Biochemically Measured Change in Alcohol Abstinence.
研究概览
简要总结
Alcohol abuse remains a significant cause of preventable morbidity and mortality in the US. Yet only 15% of those with alcohol use disorders receive treatment. Contingency Management (CM) is a cost-effective intervention for drug addiction where individuals are rewarded when they submit biological verification of drug abstinence. The researchers propose to develop an integrated CM system capable of incorporating mobile device input, that would allow them to deliver a CM intervention for problematic drinking to anyone who owns a smartphone. The mobile device input will incorporate ecological momentary assessments (EMA), geospatial mapping, and biomarker-based feedback from a portable measuring device.
详细描述
The researchers propose to develop an integrated Contingency Management (CM) system capable of incorporating mobile device input, which would allow them to deliver a CM intervention for problematic drinking to anyone who owns a smartphone. The location of participants through their cell phone will be recorded. The researchers will be using this data to create a "heat-map" to find problem areas of drinking. The application works only on iPhone 7 or a newer version with an (iPhone Operating System) iOS 13.5. If the participant does not have an iPhone 7 or a newer version, the researcher can loan one to the participant if he/she knows how to use it, but it must be returned at the end of the study.
The primary aim is to combine mobile technology, geospatial mapping, and biomarker measurement, with individual goal setting and ecological momentary assessments (EMA) feedback to launch behavioral modification strategies and progress monitoring.
People can participate if they are 1) age 18-65 years; 2) have an Alcohol Use Disorders Identification Test (AUDIT) score of 8 or higher; 3) have the ability to read and speak English; 4) have the ability to provide written informed consent; 5) have a breath alcohol of 0.00 during informed consent, and 6) can operate a smartphone with an active service provider.
The researchers will utilize an A-B-A completely within-subject design with the intent of recruiting twenty total participants from the Community in Spokane.
During the first A phase, participants will receive reinforcement for simply submitting breath samples 3 times per day between 4 and 6 hours apart.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •An Alcohol Use Disorders Identification Test (AUDIT) score of 8 or higher.
- •Ability to read and speak English.
- •Ability to provide written informed consent.
- •Breath alcohol of 0.00 during informed consent.
- •Operate a smartphone with an active service provider.
排除标准
- •Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder, severe type.
- •Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal.
- •Diagnosis of a psychotic disorder.
- •Lifetime suicide attempt or suicidality in the past year.
- •Any other medical or psychiatric condition that would compromise safe participation.
研究组 & 干预措施
Contingency management A-B-A
All participants will be assigned a single arm where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods.
干预措施: Contingency management (Behavioral)
结局指标
主要结局
Biochemically Measured Change in Alcohol Abstinence.
时间窗: Daily during 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)
Change in biochemically measured alcohol abstinence assessed through breath samples submitted three times daily.
次要结局
- Feasibility Indicator of App Usage(8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase))
- Treatment Retention(8 Weeks)
研究者
Sterling McPherson
Professor
Washington State University