- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00367575
An Internet-based Intervention for Problem Drinking
The main aim of this randomized controlled trial is to evaluate the efficacy of an Internet-delivered self-help intervention for problem drinkers in the general population.
Adult problem drinkers with home access to the Internet will be recruited from the CAMH Monitor. Subjects will be randomly assigned to receive a website address where they can obtain personalized feedback about their drinking, or to a no intervention control group.
Three-month and six-month follow-up surveys will be conducted by mail to assess drinking over the following three month periods. Collaterals will be requested and interviewed after the six-month follow-up. Subjects will be paid $40.00 and collaterals will be paid $20.00 for their participation. Drinking at three- and six-months will be compared between the groups. Subjects in the control group will be provided with the website address following the six-month follow-up.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Self-change interventions have great potential to aid the many problem drinkers who do not seek formal treatment. Because self-change interventions circumvent some of the barriers associated with traditional treatment services, they may help reduce the harm associated with alcohol abuse among untreated individuals, whose number far exceeds that of the minority who ever access formal alcohol treatment programs. Self-change/self-help materials have the added advantage of being relatively inexpensive, increasing their potential for wide distribution and attendant public health impact. The Internet is one promising route for distributing such materials to a large segment of the population. Three-quarters of Canadians and Americans use the Internet, including a large number who seek health-related information on line. Drinking self-change websites abound on the Internet, but because none has been scientifically evaluated it is unknown whether such sites do more good than harm.
By being the first large scale, controlled evaluation, this project intends to advance the science of Internet-mediated intervention as well as provide valuable public health information on the effectiveness of Internet-delivered self-change materials. Specifically, the major objective of this project is to conduct a randomized controlled evaluation of the impact of an Internet-based self-help intervention for problem drinkers in the general population.
Participants will be recruited through the ongoing general population survey - the CAMH Monitor (N = 170 after attrition), and will be randomly assigned to be sent a World Wide Web page Internet address and password for the personalized alcohol feedback program or to a no intervention control group. Three and six-month drinking outcomes will be compared between experimental conditions using structural equation modeling.
The primary hypothesis is that respondents in the Internet personalized alcohol feedback condition will display significantly improved drinking outcomes at three and six-month follow-ups as compared to respondents in the no intervention control condition. Secondary hypotheses will address the mediating or moderating role of perceived drinking norms, perceived risk and the problem drinker's social reasons for drinking.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Alberta
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Edmonton, Alberta, Canada
- University of Alberta
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Ontario
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Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
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California
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Stanford, California, Forenede Stater
- Stanford University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 years or older
- have home access to the Internet
- interested in receiving a computerized assessment of their drinking
- have a score of 8 or higher on the AUDIT.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
frequency of consumption
|
drinks per occasion
|
number of drinks in a typical week
|
frequency of 5+ consumption
|
highest number of drinks on one occasion.
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John A Cunningham, PhD, Centre for Addiction and Mental Health
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 053/2005
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Kliniske forsøg med Internet personalized alcohol feedback (PAF)
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University of HoustonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Afsluttet
-
University of North Carolina, CharlotteRekrutteringAnkelskader | Ankel Inversion ForstuvningForenede Stater
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Loyola Marymount UniversityUniversity of HoustonRekrutteringAlkoholbrugsforstyrrelse | College Drikke | Mindreårige drikkerForenede Stater
-
Butler HospitalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RekrutteringAlkoholbrugsforstyrrelseForenede Stater
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetAlkoholforbrugForenede Stater
-
Abby BraitmanNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetCollege studerende drikker
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University of MinnesotaNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University... og andre samarbejdspartnereAfsluttetCollege studerende drikkerForenede Stater
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Stanford UniversityNational Institute on Drug Abuse (NIDA); University of Wisconsin, Madison; Washington State Health Care AuthorityAktiv, ikke rekrutterendeAfhængighed, OpioidForenede Stater