The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients
Background: Interactive and mobile technology to manage alcohol use problem potentially provide continuing care by offering emotional and instrumental support anywhere and in time, but the effectiveness for maintaining abstinence has not been examined. the investigators will evaluate in this study whether the smartphone-based support system would improve outcomes for people in recovery for alcohol dependence. To enable continuous self-monitoring and self-management, the phone support system prompts subjects to take Breath Alcohol Concentration (BrAC) tests using a phone application and a Bluetooth sensor unit. The system also offers instantaneous feedback, self-management strategies, and anonymous mutual social support from other subjects.
Methods: This three-year project will be conducted in three stages, including pilot study, efficacy evaluation (12 week), and post-intervention follow-up (12 week) stage. Participants will be given a smartphone (if the subject does not have one), breathalyzer and training session. In the pilot study stage,10 subjects will be enrolled to validate the system. In the efficacy evaluation stage, the investigators will conduct a 12-week by enrolling 100 post-detoxification alcohol dependent patients who are randomized to (1) standard treatment (ST) group or (2) standard treatment plus phone-based support group (technology intervention, TI group). Participants will be assessed by Time-Line Follow-Back (TLFB) to record the frequency and quantity of alcohol consumption, visual analogue for craving, Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI), Satisfaction with Life Scale (SWLS), and Quality of life Scale (WHOQOL-BREF) and compared for outcome measures. After the 12-week trial, the investigators will take back the support system and follow the all subjects in both groups for another 12 weeks, i.e. post-intervention stage, to further understand the sustaining benefit from intervention. In addition, the investigators will identify the clinical variables or system factors that are associated with outcome measures.
Expected results: In this study, the investigators expect that in treatment-seeking alcohol dependent patients, a smartphone-supported self-management program, adding on to conventional treatment, will be beneficial in improving the drinking outcomes such as a higher abstinence rate, a lower relapse rate, and a lower drinking frequency and quantity.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Taipei、台湾、110
- 招聘中
- Ming-Chyi
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接触:
- Ming-Chyi Huang, M.D., Ph.D
- 电话号码:1219 886-2-27263141
- 邮箱:mch@tpech.gov.tw
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接触:
- Galen Hung, M.D.
- 电话号码:1305 886-2-27263141
- 邮箱:galenhung@gmail.com
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首席研究员:
- Ming-Chyi Huang, M.D., Ph.D.
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副研究员:
- Chuan-Wen Yu, Ph.D
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副研究员:
- Hao-Hua Chu, Ph.D
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 20 and 50 years;
- Use an Android phone as his/her primary phone, or be willing to use an Android phone provided by National Taiwan University as his/her primary phone during the study;
- Fulfilling the Diagnostic and Statistical Manual version IV (DSM-IV) criteria of alcohol dependence assessed by the Structured Clinical Interview;
- Complete abstinence for at least 10 days and free of any withdrawal symptoms; and
- Drug screening test results negative opiates, amphetamines, and ketamine.
Exclusion Criteria:
- A current DSM-IV diagnosis of dependence or abuse on other substances except nicotine or the use of one to two low-potency benzodiazepine tablets for sleep impairment;
- A current mental or psychiatric impairment or disease that required psychotropic medication or inpatient treatment on a psychiatric ward;
- A history of opioid or psychostimulant abuse;
- A history of psychosis, including schizophrenia, bipolar I or bipolar II disorder, and major depressive disorder with psychotic features;
- Current use of any antipsychotics;
- Homelessness;
- Pregnancy, nursing, or refusal to use a reliable method of birth control in women;
- Cognitive deficit and not thus being able to comprehend the informed consent and study procedure
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Intervention group
This group of subjects receives mobile support system and conventional treatment
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无干预:Control group
This group of patients receive conventional treatment only
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to first lapse
大体时间:12 weeks
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12 weeks
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Time to first relapse
大体时间:12 weeks
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12 weeks
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Cumulative abstinence days
大体时间:12 weeks
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12 weeks
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Number of drinks per drinking days
大体时间:12 weeks
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each visit during the 12 weeks: week 1, 2, 4, 8, 12
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12 weeks
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VAS craving measurement
大体时间:12 weeks
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each visit during the 12 weeks: week 1, 2, 4, 8, 12
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12 weeks
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complete abstinence rate
大体时间:12 weeks
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12 weeks
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Drop-out rate
大体时间:12 weeks
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each visit during the 12 weeks: week 1, 2, 4, 8, 12
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12 weeks
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合作者和调查者
调查人员
- 首席研究员:Ming-Chyi Huang, MD, PhD、Taipei City Psychiatric Center
- 学习椅:Hao-Hua Chu, PhD、Department of Computer Science and Information Engineering, National Taiwan University
- 研究主任:Chuang-Wen You, PhD、Intel-NTU Connected Context Computing Center, National Taiwan University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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