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

NCT ID: NCT02385643

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-07-31

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 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.

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

This group of subjects receives mobile support system and conventional treatment

Group Type: EXPERIMENTAL

SmartPhone Support System

Intervention Type: BEHAVIORAL

Control group

This group of patients receive conventional treatment only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SmartPhone Support System

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ming-Chyi Huang

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ming-Chyi Huang

Taipei City Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ming-Chyi Huang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei City Psychiatric Center

Hao-Hua Chu, PhD

Role: STUDY_CHAIR

Department of Computer Science and Information Engineering, National Taiwan University

Chuang-Wen You, PhD

Role: STUDY_DIRECTOR

Intel-NTU Connected Context Computing Center, National Taiwan University

Locations

Ming-Chyi

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ming-Chyi Huang, MD, PhD

Role: CONTACT

mingchyihuang@gmail.com

+886-2-27263141 ext. 1219

Facility Contacts

Ming-Chyi Huang, M.D., Ph.D

Role: primary

mch@tpech.gov.tw

886-2-27263141 ext. 1219

Galen Hung, M.D.

Role: backup

galenhung@gmail.com

886-2-27263141 ext. 1305

Other Identifiers

MOST 103-2628-B-532 -001 -MY3

Identifier Type: -

Identifier Source: org_study_id