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

NCT02385643 | Unknown

• 1 other identifier: MOST 103-2628-B-532 -001 -MY3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

alcohol dependence; abstinence; relapse prevention; mobile support system

Outcome Measures

Primary Outcomes (7)

• Time to first lapse

  12 weeks

• Time to first relapse

  12 weeks

• Cumulative abstinence days

  12 weeks

• Number of drinks per drinking days

  each visit during the 12 weeks: week 1, 2, 4, 8, 12

  12 weeks

• VAS craving measurement

  each visit during the 12 weeks: week 1, 2, 4, 8, 12

  12 weeks

• complete abstinence rate

  12 weeks

• Drop-out rate

  each visit during the 12 weeks: week 1, 2, 4, 8, 12

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

This group of subjects receives mobile support system and conventional treatment

Behavioral: SmartPhone Support System

Control group

NO INTERVENTION

This group of patients receive conventional treatment only

Interventions

SmartPhone Support System BEHAVIORAL

Intervention group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ming-Chyi Huang: lead

Study Sites (1)

Ming-Chyi

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ming-Chyi Huang, MD, PhD

  Taipei City Psychiatric Center

  PRINCIPAL INVESTIGATOR

• Hao-Hua Chu, PhD

  Department of Computer Science and Information Engineering, National Taiwan University

  STUDY CHAIR

• Chuang-Wen You, PhD

  Intel-NTU Connected Context Computing Center, National Taiwan University

  STUDY DIRECTOR

Central Study Contacts

Ming-Chyi Huang, MD, PhD

CONTACT

+886-2-27263141; mingchyihuang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Taipei City Hospital

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 11, 2015
• Study Start: September 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

TW (1)