Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Optimizing Smart Technology for Addiction Recovery (STAR)

22. juni 2026 opdateret af: University of Wisconsin, Madison

Optimizing Algorithmic Feedback About Lapse Risk for Trust, Engagement, and Clinical Outcomes for Alcohol Use Disorder

The goal of this study is to develop a machine-learning guided recovery messaging system. The main question it aims to answer is can messages be used to:

  • help people to improve their health
  • make changes in people's lives to address alcohol and substance use

Participants will:

  • complete surveys
  • use a recovery-support digital therapeutic system

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study seeks to optimize messaging components which can be implemented in a recovery support messaging system such as may accompany a digital therapeutic app, in order to determine optimal messaging to increase interaction with recovery support resources, and whether messaging has any effect on clinical outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

416

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53706
        • Rekruttering
        • University of Wisconsin

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • meet criteria for alcohol use disorder with at least moderate severity (>= 4 DSM-5 criteria)
  • in initial remission with most recent use of alcohol between 1 week and 3 months in the past
  • able to read English
  • have a smartphone and cellular plan that supports STAR use (Apple iOS or Android)

Exclusion Criteria:

  • medical or psychiatric co-morbidities that preclude use of a smartphone

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: STAR
Participants will use the STAR automated recover support system for 4 months
Enhed: STAR
Automated recovery support messaging system for participants with alcohol use disorder (AUD), paired with a machine learning guided relapse risk prediction model.
Andre navne:
  • Smart Technology for Addiction Recovery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant engagement with the STAR system
Tidsramme: data collected at 2 and 4 months
Measured as days of engagement with the recovery system.
data collected at 2 and 4 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of heavy drinking days in the previous 28 days
Tidsramme: data collected at baseline, 2, 4 months
Data collected via Timeline Followback (TLFB) conducted by interview at 0, 2, and 4 months. Ecological Momentary Assessment (EMA) lapse reports will be used to supplement the TLFB. These are daily surveys where the participant answers the question "have you had a drink you have not yet reported?" (Yes/No). If yes they are asked to indicate the date of their drinking and how many drinks they consumed that day (less than 1, 1-2, 3, 4, 5-6, 7-8, over 8). Four or more drinks are considered heavy drinking days for women and greater than 4 drinks are considered heavy drinking days for men.
data collected at baseline, 2, 4 months
Number of drinking days in the previous 28 days
Tidsramme: data collected at baseline, 2, 4 months
Data collected via Timeline Followback (TLFB) conducted by interview at 0, 2, and 4 months. EMA lapse reports will be used to supplement the TLFB. These are daily surveys where the participant answers the question "have you had a drink you have not yet reported?" (Yes/No). If yes, they are asked to indicate the date of their drinking.
data collected at baseline, 2, 4 months
Flourishing Scale Score
Tidsramme: data collected at baseline, 2, 4 months
10 items rated on 0-10 Likert scale where lower scores represent worse functioning and higher scores represent better functioning. Total possible range of scores is from 0-100.
data collected at baseline, 2, 4 months
Generalized Anxiety Disorder-7 (GAD-7) Score
Tidsramme: data collected at baseline, 2, 4 months
7 items rated on 0-3 Likert scale where lower scores represent better functioning and higher scores represent worse functioning. Total possible range of scores is from 0-21.
data collected at baseline, 2, 4 months
Multidimensional Inventory of Recovery Capital (MIRC) Score: Total Score
Tidsramme: data collected at baseline, 2, 4 months
1-4 Likert scale. Some items are reverse coded but higher total scores represent better functioning and lower total scores represent worse functioning. Scored as total score 4-56.
data collected at baseline, 2, 4 months
Multidimensional Inventory of Recovery Capital (MIRC) Score: Each Domain
Tidsramme: data collected at baseline, 2, 4 months
1-4 Likert scale. Some items are reverse coded but higher total scores represent better functioning and lower total scores represent worse functioning. Scored in 4 domains (social, physical, human, and cultural), each from 1-14.
data collected at baseline, 2, 4 months
Patient Health Questionnaire (PQH-9) Score
Tidsramme: data collected at baseline, 2, 4 months
9 items rated on 1-4 Likert scale. Total possible range of scores from 0-27 where lower scores represent better functioning and higher scores represent worse functioning.
data collected at baseline, 2, 4 months
Digital Working Alliance Inventory (D-WAI)
Tidsramme: data collected at 2 and 4 months
Six items rated on 1-7 Likert scale. Scored in 3 domains (Goals, Tasks, Bonds, each with 2 items) with possible scores from 2 to 14 where higher scores represent greater alliance with the STAR system in that domain.
data collected at 2 and 4 months
Message Usefulness
Tidsramme: data collected at 2 and 4 months
Seven items rated on 1-7 Likert scale. Total possible scores from 7 to 49 where higher scores represent greater valuation of STAR message usefulness.
data collected at 2 and 4 months
Trust of the System
Tidsramme: data collected at 2 and 4 months
Ten items rated on 1-7 Likert scale. Total possible scores from 10 to 70 where higher scores represent greater trust in the STAR system.
data collected at 2 and 4 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Wisconsin, Madison

Samarbejdspartnere

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Efterforskere

  • Ledende efterforsker: John Curtin, PhD, University of Wisconsin, Madison

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 (Faktiske)

24. september 2025

Primær færdiggørelse (Anslået)

31. januar 2029

Studieafslutning (Anslået)

31. juli 2029

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024-0869
  • A487400 (Anden identifikator: UW Madison)
  • 1R01AA031762-01 (U.S. NIH-bevilling/kontrakt)
  • Protocol Version 4/22/2026 (Anden identifikator: UW Madison)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Abonner