Promoting Responsible Drinking: An Internet-based, Interactive Computer Tailored Intervention

Study Overview
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Brief Summary
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Excessive alcohol use is associated with a range of serious and costly health, social, and economic consequences at the individual and societal level. This program of research serves as a venue by which to produce and test an innovative, science-based, and cost-effective means to intervene in a private, convenient, and individualized way with employed adults who report non-dependent levels of risky drinking. Responsible Drinking offers computer-tailored intervention sessions directed at increasing readiness to limit drinking to national guidelines for low-risk drinking and a complementary dynamic web portal providing additional information, activities, and strategies designed to activate and reinforce the change process. The primary objective is to complete and enhance the development of Responsible Drinking and test it in an effectiveness trial. In Phase II the program capabilities and innovation will expand to integrate the e-Health components (CTI and e-Workbook) with m-Health (mobile health) technologies. The e-Health components will be enhanced to offer a more interactive and engaging user experience. In addition, m-Health technologies (text messaging and mobile device browsing optimization) will be integrated to support engagement in the program and flexible delivery options. 996 employed adults will be recruited to participate in the randomized trial. The treatment group will receive three intervention sessions during the course of six months and group differences on a number of outcomes will be evaluated at 12 and 18 month follow-up assessments.

Official Title
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Promoting Responsible Drinking: An Internet-based, Interactive Computer Tailored Intervention

Conditions
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Regular Heavy AOD Use, Excessive Drinking

Intervention / Treatment
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* Behavioral: Treatment Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking 21 years of age or older not enrolled full-time in college employed part or full time not pregnant consumed alcohol in the past 30 days exceeded the NIAAA gender-specific low-risk drinking guidelines in the last 30 days not currently interested in or ever having received treatment for substance abuse or dependence not ever having received a physician recommendation to avoid or reduce alcohol use scoring 9 or less on the Alcohol Use Disorders Identification Test (AUDIT-C).

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>The treatment group will receive three interactive Computer Tailored Intervention (CTI) sessions during the course of six months, which will include tailored feedback based on the user's responses, and two assessment only follow-up sessions at twelve and eighteen months. | Behavioral: Treatment Group<br>* Responsible Drinking intervention sessions include an internet-based, computer-tailored intervention (CTI) grounded in the Transtheoretical Model of Behavior Change (TTM). The intervention includes stage-matched and tailored feedback on alcohol use, alcohol-related problems, and theoretically identified behavior change strategies, as well as access to a web-based portal with stage-matched interactive activities to reinforce and promote stage progression. Finally, the intervention will include 7 months of stage-matched behavior change SMS messages.<br>|
| No Intervention: Control Group<br>The control group will receive four assessment only sessions during 18 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who reach criteria for limiting drinking according to low-risk drinking guidelines | To assess efficacy by comparing treatment and control group participants who are at-risk at baseline - assessed using a self-report Transtheoretical Model of Behavior Change (TTM) stage of change measure | 18 month follow-up | 
| Quantity of alcohol use (number of drinks per week, number of drinks per drinking day) | To assess efficacy by comparing treatment and control group participants who are at-risk at baseline - accessed using continuous measures of drinking behavior | 18 month follow-up | 
| Frequency of alcohol use (days drinking above recommended limits during the past month, number of drinking days in the past month) | To assess efficacy by comparing treatment and control group participants who are at-risk at baseline- accessed using continuous measures of drinking behavior | 18 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratings of alcohol-related problems | To assess the efficacy of the intervention by comparing treatment and control group participants who are at-risk at baseline - accessed using the SIP measure | 18 month follow-up | 
| Well-being related to productivity | To assess the efficacy of the intervention by comparing treatment and control group participants who are at-risk at baseline - Accessed using WBA-F and WBA-P | 18 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excessive Drinking, Hazardous Drinking