The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Taipei, Taiwan, 110
- Rekrytering
- Ming-Chyi
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Kontakt:
- Ming-Chyi Huang, M.D., Ph.D
- Telefonnummer: 1219 886-2-27263141
- E-post: mch@tpech.gov.tw
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Kontakt:
- Galen Hung, M.D.
- Telefonnummer: 1305 886-2-27263141
- E-post: galenhung@gmail.com
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Huvudutredare:
- Ming-Chyi Huang, M.D., Ph.D.
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Underutredare:
- Chuan-Wen Yu, Ph.D
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Underutredare:
- Hao-Hua Chu, Ph.D
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Intervention group
This group of subjects receives mobile support system and conventional treatment
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Inget ingripande: Control group
This group of patients receive conventional treatment only
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Time to first lapse
Tidsram: 12 weeks
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12 weeks
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Time to first relapse
Tidsram: 12 weeks
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12 weeks
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Cumulative abstinence days
Tidsram: 12 weeks
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12 weeks
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Number of drinks per drinking days
Tidsram: 12 weeks
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each visit during the 12 weeks: week 1, 2, 4, 8, 12
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12 weeks
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VAS craving measurement
Tidsram: 12 weeks
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each visit during the 12 weeks: week 1, 2, 4, 8, 12
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12 weeks
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complete abstinence rate
Tidsram: 12 weeks
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12 weeks
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Drop-out rate
Tidsram: 12 weeks
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each visit during the 12 weeks: week 1, 2, 4, 8, 12
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12 weeks
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ming-Chyi Huang, MD, PhD, Taipei City Psychiatric Center
- Studiestol: Hao-Hua Chu, PhD, Department of Computer Science and Information Engineering, National Taiwan University
- Studierektor: Chuang-Wen You, PhD, Intel-NTU Connected Context Computing Center, National Taiwan University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MOST 103-2628-B-532 -001 -MY3
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