Ultra-brief Intervention for Problem Drinkers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00688584|
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : April 9, 2013
The major objective of this proposal is to conduct a randomized controlled trial of an ultra-brief, personalized feedback intervention (a pamphlet) for problem drinkers. Subjects will be recruited via a telephone survey which will collect baseline data. The households of half of the subjects will receive the pamphlet as unaddressed ad mail shortly thereafter. Follow-up interviews will be conducted, by telephone, three and six months after the mailing of the pamphlets.
Hypothesis 1: Respondents from households who receive the pamphlet will display significantly improved drinking outcomes at the three-month and six-month follow-ups as compared to respondents from households in the no intervention control condition.
Hypothesis 2: More calls will be received on a help-line listed on the pamphlet (and advertised elsewhere) from residents of households who receive the pamphlet as compared to residents from households who do not receive the pamphlet.
Hypotheses 3 - 6 deal with mediator and moderator hypotheses, exploring the role of perceived risk, perceived drinking norms, and drinking for social reasons.
|Condition or disease||Intervention/treatment||Phase|
|Problem Drinking Alcoholism||Behavioral: Pamphlet-based personalized alcohol feedback (PAF) Behavioral: control pamphlet condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1767 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultra-brief Intervention for Problem Drinkers|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Behavioral: Pamphlet-based personalized alcohol feedback (PAF)
participants in this condition will be mailed their respective pamphlets
|Placebo Comparator: 2||
Behavioral: control pamphlet condition
The goal is to test if it is the specific content of the pamphlet that leads to the change or just the receipt of any pamphlet.
|No Intervention: No intervention control|
- frequency of alcohol consumption [ Time Frame: measured at 3 and 6 months into the study ]
- alcoholic drinks per occasion [ Time Frame: measured at 3 and 6 months into the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688584
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98105-6099|
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2H1|
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Principal Investigator:||John Cunningham, PhD||Centre for Addiction and Mental Health|