Alcohol Dependence Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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