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

5. marts 2015 opdateret af: Ming-Chyi Huang

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 110
        • Rekruttering
        • Ming-Chyi
        • Kontakt:
          • Ming-Chyi Huang, M.D., Ph.D
          • Telefonnummer: 1219 886-2-27263141
          • E-mail: mch@tpech.gov.tw
        • Kontakt:
        • Ledende efterforsker:
          • Ming-Chyi Huang, M.D., Ph.D.
        • Underforsker:
          • Chuan-Wen Yu, Ph.D
        • Underforsker:
          • Hao-Hua Chu, Ph.D

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention group
This group of subjects receives mobile support system and conventional treatment
Adfærdsmæssigt: SmartPhone Support System
Ingen indgriben: Control group
This group of patients receive conventional treatment only

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ming-Chyi Huang

Efterforskere

  • Ledende efterforsker: Ming-Chyi Huang, MD, PhD, Taipei City Psychiatric Center
  • Studiestol: Hao-Hua Chu, PhD, Department of Computer Science and Information Engineering, National Taiwan University
  • Studieleder: Chuang-Wen You, PhD, Intel-NTU Connected Context Computing Center, National Taiwan University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2013

Primær færdiggørelse (Forventet)

1. juli 2017

Studieafslutning (Forventet)

1. juli 2017

Datoer for studieregistrering

Først indsendt

26. februar 2015

Først indsendt, der opfyldte QC-kriterier

5. marts 2015

Først opslået (Skøn)

11. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MOST 103-2628-B-532 -001 -MY3

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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