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

Not Applicable

Completed

• Conditions: Regular Heavy AOD Use; Excessive Drinking
• Interventions: Behavioral: Treatment Group

• Registration Number: NCT02126163
• Lead Sponsor: Pro-Change Behavior Systems

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 Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-27
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Treatment Group	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.

Primary Outcome Measures

Name	Time	Method
Quantity of alcohol use (number of drinks per week, number of drinks per drinking day)	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)	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
Proportion of participants who reach criteria for limiting drinking according to low-risk drinking guidelines	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

Secondary Outcome Measures

Name	Time	Method
Well-being related to productivity	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
Ratings of alcohol-related problems	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

Trial Locations

Locations (1)

Pro-Change Behavior Systems, Inc.; 🇺🇸 South Kingstown, Rhode Island, United States