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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary:

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

Detailed Summary:
Sponsor: Ming-Chyi Huang

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Taipei City Hospital

Dates:
Date Received: February 26, 2015
Date Started: September 2013
Date Completion: July 2017
Last Updated: March 5, 2015
Last Verified: March 2015