Tailored Mobile Text Messaging to Reduce Problem Drinking
12. oktober 2016 opdateret af: Northwell Health
This study is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in stopping or reducing their alcohol consumption; and test and compare it to tailored but static, once a day messaging, gain framed messaging, and ecological momentary assessment only.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The proposed development study entitled, Tailored Mobile Text Messaging to Reduce Problem Drinking is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in stopping or reducing their alcohol consumption.
This intervention includes messages tailored to baseline assessment results (including drinking times) that are adaptive to ongoing drinking patterns and goal achievement via interactive ecological momentary assessment (EMA).
Other features include participant initiated help messaging and support network alerts.
We will conduct beta research with 40 problem drinkers to assess messaging preferences and acceptability, and then conduct a pilot test with 10 PDs.
In Stage 1b, we aim to test this intervention and understand the mechanisms of action of different text messaging interventions with 200 problem drinkers over a 12-week period.
We propose to compare four types of messaging: 1) Tailored content and timed messaging adaptive to the participants current state (Stage 1a intervention); 2) Tailored content messaging (not adaptive or timed) sent at 3 pm every day; 3) Untailored consequence based messages sent at 3 pm every day; and 4) Brief feedback and EMA only.
Assessments will be completed at baseline, through weekly EMA via SMS and at week 12 via a web-based follow-up assessment.
Primary outcomes include drinks per drinking day, days of heavy drinking, and average drinks per week as measured through weekly EMA.
Additional outcomes will include drinking related consequences, goal commitment and intervention satisfaction.
Outcomes will be used to modify the intervention and to prepare for a larger Stage 1c RCT.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
174
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
Great Neck, New York, Forenede Stater, 11021
- Feinstein Institute for Medical Research / North Shore-LIJ Health System
-
-
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
21 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Participants must:
- be fluent and able to read in English at the eighth grade level
- be between the ages of 21 and 65
- have an estimated average weekly consumption of greater than 15 or 24 standard drinks per week for women and men, respectively
- be willing to reduce their drinking to non-hazardous levels
- be willing to provide informed consent
- own a mobile phone and have an active email address and are willing to receive and respond to up to 115 text messages total per month (average = 50)
Exclusion Criteria:
- Participants will be excluded from the study if they
- present with significant substance use or a current substance use disorder (for any substance other than alcohol, nicotine, or caffeine), which is defined as greater than once weekly use in the past month
- present with a serious psychiatric illness or suicide risk as measured by previous inpatient treatment, medications for psychosis or recent suicidality; demonstrate clinically severe alcoholism, as evidenced by physical withdrawal symptoms or a history of serious withdrawal symptoms (e.g., hallucinations, seizures, or delirium tremens), and score greater than 12 on the Short Alcohol Withdrawal Scale (SAWS)
- express a desire or intent to obtain additional substance abuse treatment while in the study
- report a medical condition that precludes drinking any alcohol; or
- demonstrate cognitive impairment as evidenced a score of less than 7 out of 10 on the consent form quiz
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 |
|---|---|
|
Aktiv komparator: Tailored not adaptive based Intervention
Tailored Text Messaging - not adaptive in the moment and once a day intervention to reduce problem drinking
|
Baseline tailored not adaptive
|
|
Andet: Ecological Momentary Assessment
Mobile Assessment only
|
EMA only
|
|
Eksperimentel: Tailored Adaptive Text Messaging
Tailored Adaptive Text Messaging intervention to reduce problem drinking
|
Adaptive
|
|
Aktiv komparator: Consequence based text messaging
Consequence based Text Messaging intervention to reduce problem drinking
|
Loss Framed
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Days of Heavy Drinking (DHD)
Tidsramme: 12 weeks
|
12 weeks
|
|
Average Drinks per Week (ADW)
Tidsramme: 12 weeks
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Drinking Related Consequences
Tidsramme: 12 weeks
|
12 weeks
|
|
Goal Commitment
Tidsramme: 12 weeks
|
12 weeks
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Intervention Satisfaction
Tidsramme: 12 weeks
|
12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Fred Muench, PhD, Feinstein Institute for Medical Research / North Shore-LIJ Health System
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. februar 2014
Primær færdiggørelse (Faktiske)
1. december 2015
Studieafslutning (Faktiske)
1. august 2016
Datoer for studieregistrering
Først indsendt
20. juni 2013
Først indsendt, der opfyldte QC-kriterier
21. juni 2013
Først opslået (Skøn)
24. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AA021502-2
- 1R34AA021502-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
Once cleaned and published will make available
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 .