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The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients

2015年3月5日 更新者:Ming-Chyi Huang

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

地位

未知

条件

研究类型

介入性

注册 (预期的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taipei、台湾、110
        • 招聘中
        • Ming-Chyi
        • 接触:
          • Ming-Chyi Huang, M.D., Ph.D
          • 电话号码:1219 886-2-27263141
          • 邮箱:mch@tpech.gov.tw
        • 接触:
        • 首席研究员:
          • Ming-Chyi Huang, M.D., Ph.D.
        • 副研究员:
          • Chuan-Wen Yu, Ph.D
        • 副研究员:
          • Hao-Hua Chu, Ph.D

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age between 20 and 50 years;
  2. 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;
  3. Fulfilling the Diagnostic and Statistical Manual version IV (DSM-IV) criteria of alcohol dependence assessed by the Structured Clinical Interview;
  4. Complete abstinence for at least 10 days and free of any withdrawal symptoms; and
  5. Drug screening test results negative opiates, amphetamines, and ketamine.

Exclusion Criteria:

  1. 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;
  2. A current mental or psychiatric impairment or disease that required psychotropic medication or inpatient treatment on a psychiatric ward;
  3. A history of opioid or psychostimulant abuse;
  4. A history of psychosis, including schizophrenia, bipolar I or bipolar II disorder, and major depressive disorder with psychotic features;
  5. Current use of any antipsychotics;
  6. Homelessness;
  7. Pregnancy, nursing, or refusal to use a reliable method of birth control in women;
  8. Cognitive deficit and not thus being able to comprehend the informed consent and study procedure

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Intervention group
This group of subjects receives mobile support system and conventional treatment
无干预:Control group
This group of patients receive conventional treatment only

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
Time to first lapse
大体时间:12 weeks
12 weeks
Time to first relapse
大体时间:12 weeks
12 weeks
Cumulative abstinence days
大体时间:12 weeks
12 weeks
Number of drinks per drinking days
大体时间:12 weeks
each visit during the 12 weeks: week 1, 2, 4, 8, 12
12 weeks
VAS craving measurement
大体时间:12 weeks
each visit during the 12 weeks: week 1, 2, 4, 8, 12
12 weeks
complete abstinence rate
大体时间:12 weeks
12 weeks
Drop-out rate
大体时间:12 weeks
each visit during the 12 weeks: week 1, 2, 4, 8, 12
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年9月1日

初级完成 (预期的)

2017年7月1日

研究完成 (预期的)

2017年7月1日

研究注册日期

首次提交

2015年2月26日

首先提交符合 QC 标准的

2015年3月5日

首次发布 (估计)

2015年3月11日

研究记录更新

最后更新发布 (估计)

2015年3月11日

上次提交的符合 QC 标准的更新

2015年3月5日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • MOST 103-2628-B-532 -001 -MY3

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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