Clinical trial NCT02126163: Promoting Responsible Drinking: An Internet-based, Interactive Computer Tailored Intervention
Official title: Promoting Responsible Drinking: An Internet-based, Interactive Computer Tailored Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regular Heavy AOD Use
Excessive Drinking
Keywords: Excessive Drinking
Hazardous Drinking
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. English speaking
2. 21 years of age or older
3. not enrolled full-time in college
4. employed part or full time
5. not pregnant
6. consumed alcohol in the past 30 days
7. exceeded the NIAAA gender-specific low-risk drinking guidelines in the last 30 days
8. not currently interested in or ever having received treatment for substance abuse or dependence
9. not ever having received a physician recommendation to avoid or reduce alcohol use
10. scoring 9 or less on the Alcohol Use Disorders Identification Test (AUDIT-C).

Primary outcomes:
measure: Proportion of participants who reach criteria for limiting drinking according to low-risk drinking guidelines
timeFrame: 18 month follow-up
measure: Quantity of alcohol use (number of drinks per week, number of drinks per drinking day)
timeFrame: 18 month follow-up
measure: Frequency of alcohol use (days drinking above recommended limits during the past month, number of drinking days in the past month)
timeFrame: 18 month follow-up
Secondary outcomes:
measure: Ratings of alcohol-related problems
timeFrame: 18 month follow-up
measure: Well-being related to productivity
timeFrame: 18 month follow-up
Other outcomes:
Locations:
city: South Kingstown
country: United States
facility: Pro-Change Behavior Systems, Inc.
state: Rhode Island
Study officials:
affiliation: Pro-Change Behavior Systems, Inc.
name: Deborah A Levesque, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mauriello LM, Gokbayrak NS, Van Marter DF, Paiva AL, Prochaska JM. An Internet-Based Computer-Tailored Intervention to Promote Responsible Drinking: Findings from a Pilot Test with Employed Adults. Alcohol Treat Q. 2011 Winter;30(1):91-108. doi: 10.1080/07347324.2012.635528.