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

Primary Purpose

Alcohol Dependence

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
SmartPhone Support System
Sponsored by
Ming-Chyi Huang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring alcohol dependence, abstinence, relapse prevention, mobile support system

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ming-ChyiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

This group of subjects receives mobile support system and conventional treatment

This group of patients receive conventional treatment only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 26, 2015
Last Updated
March 5, 2015
Sponsor
Ming-Chyi Huang
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1. Study Identification

Unique Protocol Identification Number
NCT02385643
Brief Title
The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ming-Chyi Huang

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
alcohol dependence, abstinence, relapse prevention, mobile support system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
This group of subjects receives mobile support system and conventional treatment
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group of patients receive conventional treatment only
Intervention Type
Behavioral
Intervention Name(s)
SmartPhone Support System
Primary Outcome Measure Information:
Title
Time to first lapse
Time Frame
12 weeks
Title
Time to first relapse
Time Frame
12 weeks
Title
Cumulative abstinence days
Time Frame
12 weeks
Title
Number of drinks per drinking days
Description
each visit during the 12 weeks: week 1, 2, 4, 8, 12
Time Frame
12 weeks
Title
VAS craving measurement
Description
each visit during the 12 weeks: week 1, 2, 4, 8, 12
Time Frame
12 weeks
Title
complete abstinence rate
Time Frame
12 weeks
Title
Drop-out rate
Description
each visit during the 12 weeks: week 1, 2, 4, 8, 12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Chyi Huang, MD, PhD
Phone
+886-2-27263141
Ext
1219
Email
mingchyihuang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Chyi Huang, MD, PhD
Organizational Affiliation
Taipei City Psychiatric Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hao-Hua Chu, PhD
Organizational Affiliation
Department of Computer Science and Information Engineering, National Taiwan University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chuang-Wen You, PhD
Organizational Affiliation
Intel-NTU Connected Context Computing Center, National Taiwan University
Official's Role
Study Director
Facility Information:
Facility Name
Ming-Chyi
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Chyi Huang, M.D., Ph.D
Phone
886-2-27263141
Ext
1219
Email
mch@tpech.gov.tw
First Name & Middle Initial & Last Name & Degree
Galen Hung, M.D.
Phone
886-2-27263141
Ext
1305
Email
galenhung@gmail.com
First Name & Middle Initial & Last Name & Degree
Ming-Chyi Huang, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Chuan-Wen Yu, Ph.D
First Name & Middle Initial & Last Name & Degree
Hao-Hua Chu, Ph.D

12. IPD Sharing Statement

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

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