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

NCT ID: NCT02126163

Last Updated: 2016-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Regular Heavy AOD Use Excessive Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Treatment Group

Intervention Type 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.

Control Group

The control group will receive four assessment only sessions during 18 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pro-Change Behavior Systems

OTHER

Sponsor Role lead

Responsible Party

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Deborah Levesque

Chief Science Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah A Levesque, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pro-Change Behavior Systems, Inc.

Locations

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Pro-Change Behavior Systems, Inc.

South Kingstown, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22448087 (View on PubMed)

Other Identifiers

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2R44AA01733-02

Identifier Type: -

Identifier Source: org_study_id

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