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Completed

NCT Number: NCT02126163

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

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.

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Key information

Conditions

Regular Heavy AOD Use Excessive Drinking

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pro-Change Behavior Systems, Inc.

South Kingstown, Rhode Island, 02879, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

treatment group

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Pro-Change Behavior Systems

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2014
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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