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

Excessive Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126163
• Other study ID #: 2R44AA01733-02
• Status: Completed
• Phase: N/A
• First received: April 27, 2014
• Last updated: March 23, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Pro-Change Behavior Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Excessive Drinking
• Polydipsia
• Regular Heavy AOD Use

Intervention

Behavioral:
• Treatment Group
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.

Locations

Country	Name	City	State
United States	Pro-Change Behavior Systems, Inc.	South Kingstown	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Pro-Change Behavior Systems

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mauriello LM, Gökbayrak 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No