Regular Heavy AOD UseNCT02126163
Promoting Responsible Drinking: An Internet-based, Interactive Computer Tailored Intervention
A study testing Treatment Group in people with Regular Heavy AOD Use and Excessive Drinking, run by Pro-Change Behavior Systems at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Regular Heavy AOD Use, Excessive Drinking
- What is being tested?
- Treatment Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pro-Change Behavior Systems, Inc.
South Kingstown, Rhode Island, 02879
About this study
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.
- Conditions
- Regular Heavy AOD Use, Excessive Drinking
- Being tested
- Treatment Group
- Keywords
- Excessive Drinking, Hazardous Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Behavioral: Treatment Group |
| Control Group | No intervention | The control group will receive four assessment only sessions during 18 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 month follow-up
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
Measured: 18 month follow-up
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
Measured: 18 month follow-up
Secondary outcomes (2)
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
Measured: 18 month follow-up
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
Measured: 18 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regular Heavy AOD UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Levesque, Pro-Change Behavior Systems
- Investigators
- Deborah A Levesque, Ph.D., Principal investigator, Pro-Change Behavior Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126163
- Sponsor's protocol ID
- 2R44AA01733-02
- Status last verified
- Mar 2016
- First submitted
- 27 Apr 2014
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22448087
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Responsible Drinking: An Internet-based, Interactive Computer Tailored Intervention
- ClinicalTrials.gov ID
- NCT02126163
- Acronym / sponsor ID
- 2R44AA01733-02
- Conditions
- Regular Heavy AOD Use, Excessive Drinking
- Keywords
- Excessive Drinking, Hazardous Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Pro-Change Behavior SystemsUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Treatment GroupThe 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. |
| Control Group | No intervention | –The control group will receive four assessment only sessions during 18 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- English speaking
- 21 years of age or older
- not enrolled full-time in college
- employed part or full time
- not pregnant
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment GroupResponsible 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. | Behavioural | Treatment Group |
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
2 secondary outcomes
Ratings of alcohol-related problems
Time frame: 18 month follow-up
Well-being related to productivity
Time frame: 18 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Background: PubMed 22448087Mauriello 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah A Levesque, Ph.D. principal investigator
Pro-Change Behavior Systems, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Group in people with Regular Heavy AOD Use and Excessive Drinking, run by Pro-Change Behavior Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who reach criteria for limiting drinking according to low-risk drinking guidelines (time frame: 18 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.