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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Pro-Change Behavior Systems

Current Primary Outcome:

• Proportion of participants who reach criteria for limiting drinking according to low-risk drinking guidelines [ Time Frame: 18 month follow-up ]
  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
• Quantity of alcohol use (number of drinks per week, number of drinks per drinking day) [ Time Frame: 18 month follow-up ]
  To assess efficacy by comparing treatment and control group participants who are at-risk at baseline - accessed using continuous measures of drinking behavior
• Frequency of alcohol use (days drinking above recommended limits during the past month, number of drinking days in the past month) [ Time Frame: 18 month follow-up ]
  To assess efficacy by comparing treatment and control group participants who are at-risk at baseline- accessed using continuous measures of drinking behavior

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Ratings of alcohol-related problems [ Time Frame: 18 month follow-up ]
  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
• Well-being related to productivity [ Time Frame: 18 month follow-up ]
  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

Original Secondary Outcome: Same as current

Information By: Pro-Change Behavior Systems

Dates:
Date Received: April 27, 2014
Date Started: April 2014
Date Completion:
Last Updated: March 23, 2016
Last Verified: March 2016