Alcohol AbuseNCT02978027
Mentored Research on Improving Alcohol Brief Interventions in Medical Settings
A study testing Brief Advice, NIAAA Clinician's Guide and Motivational Interviewing (MI) in people with Alcohol Abuse, run by University of New Mexico at 1 site in United States.
Trial summary
The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels. More than 50% of alcohol health consequences occur in risky, non-dependent drinkers. Increasing the efficacy and efficiency of brief interventions in medical setting could significantly reduce the public health impacts of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Brief Advice, NIAAA Clinician's Guide and Motivational Interviewing (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: patient in University of New Mexico Family and Community Medicine Clinic (e.g. Family Practice, Southeast Height, Northeast Height, University Clinic, South Valley), positive NIAAA single question screen (>0), AUDIT-C score <7, >18 years old, ability to read and speak English, and willing to be contacted for follow-up.
Exclusion Criteria: active suicidality, incarceration, obvious cognitive impairment, unable to provide informed consent, current involvement in an alcohol research study or people who are specifically seeking help for alcohol problems, and pregnancy or intent to become pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of New Mexico
Albuquerque, New Mexico, 87131
About this study
The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels. More than 50% of alcohol health consequences occur in risky, non-dependent drinkers. Increasing the efficacy and efficiency of brief interventions in medical setting could significantly reduce the public health impacts of risky drinking. There is intense interest in conducting motivational interviewing (MI) informed brief interventions for risky alcohol use in medical settings, but little empirical information is available regarding which MI behavioral and interpersonal style components drive effectiveness. The field would benefit greatly from empirically-based Stage 1 treatment development and modeling studies to delineate the degree to which adding motivational interviewing components to brief intervention improves outcome.
Read the detailed description
The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels, placing them at risk for a variety of physical, mental health, and social consequences. More than 50% of alcohol health consequences occur in risky, non-dependent drinkers. Increasing the efficacy and efficiency of brief interventions in medical setting could significantly reduce the public health impacts of risky drinking. Despite overall positive findings for brief interventions, there are high levels of variability in effects, with meta-analyses reporting significant unexplained heterogeneity in outcomes that is likely accounted for by differences in intervention components and strategies. There is intense interest in conducting motivational interviewing (MI) informed brief interventions for risky alcohol use in medical settings, but little empirical information is available regarding which MI behavioral and interpersonal style components drive effectiveness.
Following promising efficacy trials from counseling applications, MI was translated into brief (5-15 minute) interactions and subjected to randomized controlled trial methodology. Lack of mixed-methods, Stage 1 treatment development is evidenced by our inability to provide consistent delineation of key intervention components and mechanisms of action. Variability in these factors is likely responsible for the wide variability in effects observed in meta-analyses of brief interventions. Many MI skills and behaviors require significant training and supervision and increased patient-provider interaction time. The field would benefit greatly from empirically-based Stage 1 treatment development and modeling studies to delineate the degree to which adding motivational interviewing components to brief intervention improves outcome.
- Conditions
- Alcohol Abuse
- Being tested
- Brief Advice, NIAAA Clinician's Guide, Motivational Interviewing (MI)
- Keywords
- motivational interviewing, brief alcohol intervention in primary care
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief AdviceBehavioural
NIAAA Clinician's GuideBehavioural
Motivational Interviewing (MI)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Brief Advice | Active comparator | The brief advice protocol was designed by removing MI-consistent elements from the NIAAA Clinician's Guide. The protocol involves screening and assessment using the NIAAA pre-screen and single-question screen and assessing for quantity and frequency. Patients exceeding recommended limits receive feedback, information, and advice to cut down drinking to recommended levels. All patients are provided with a tip sheet on strategies for cutting down and encouraged to follow-up with a behavioral health provider with any questions or concerns. Receives: Behavioral: Brief Advice |
| NIAAA Clinician's Guide | Active comparator | The NIAAA brief intervention was adapted directly from the NIAAA publication "Helping Patients Who Drink Too Much: A Clinician's Guide". The protocol screens using the NIAAA pre-screen and single-questions. Patients exceeding recommended limits receive feedback, information, and advice to cut down. For patients unwilling to make a change, the clinician restates their concern, encourages self reflection by asking the patient about reasons to cut down on drinking and barriers to change, and reaffirms willingness to help. For patients willing to make a change, the clinician helps the patient develop a plan to cut down within maximum limits, agree on specific steps and strategies, and provides a tip sheet on strategies for cutting down. Receives: Behavioral: NIAAA Clinician's Guide |
| Motivational Interviewing (MI) | Experimental | The MI intervention condition was also adapted from the NIAAA Clinician's Guide, with additional modification to include elements of MI. Clinicians normalize Screening and Brief Intervention (SBI) and ask the patient's permission before discussing alcohol use. The NIAAA pre-screen and single-question screen are administered. Assessment of quantity, frequency, and Alcohol Use Disorder symptoms is done using open questions. The ask-tell-ask technique is used to share feedback and exchange information regarding U.S adult drinking patterns. For patients low in readiness to make a change, clinicians build readiness using structured MI tools. For patients high in readiness to change, the ask-tell-ask technique is used to explore strategies for cutting down and develop an action plan. Receives: Behavioral: Motivational Interviewing (MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number days Exceeded Recommended Drinking Limits
Measured: 30 days
Secondary outcomes (2)
Drinks Per Drinking Day
Measured: 30 days
Percent Days Abstinent
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJul 2014
- Primary completionSep 2017
- Study completionSep 2017
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 Alcohol AbuseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Jennifer Hettema, PhD, Principal investigator, The University of New Mexico Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978027
- Sponsor's protocol ID
- K23AA020865
- Other IDs
- K23AA020865
- Status last verified
- Oct 2018
- First submitted
- 28 Nov 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hettema JE, Cockrell SA, Reeves A, Ingersoll KS, Lum PJ, Saitz R, Murray-Krezan CM, Carrejo VA. Development and differentiability of three brief interventions for risky alcohol use that include varying doses of motivational interviewing. Addict Sci Clin Pract. 2018 Feb 27;13(1):6. doi: 10.1186/s13722-017-0102-0.
PubMed 29482632
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentored Research on Improving Alcohol Brief Interventions in Medical Settings
- ClinicalTrials.gov ID
- NCT02978027
- Acronym / sponsor ID
- K23AA020865
- Conditions
- Alcohol Abuse
- Keywords
- motivational interviewing, brief alcohol intervention in primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Nov 2016 (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.
The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels. More than 50% of alcohol health consequences occur in risky, non-dependent drinkers. Increasing the efficacy and efficiency of brief interventions in medical setting could significantly reduce the public health impacts of risky drinking. There is intense interest in conducting motivational interviewing (MI) informed brief interventions for risky alcohol use in medical settings, but little empirical information is available regarding which MI behavioral and interpersonal style components drive effectiveness. The field would benefit greatly from empirically-based Stage 1 treatment development and modeling studies to delineate the degree to which adding motivational interviewing components to brief intervention improves outcome.
Detailed description
The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels, placing them at risk for a variety of physical, mental health, and social consequences. More than 50% of alcohol health consequences occur in risky, non-dependent drinkers. Increasing the efficacy and efficiency of brief interventions in medical setting could significantly reduce the public health impacts of risky drinking. Despite overall positive findings for brief interventions, there are high levels of variability in effects, with meta-analyses reporting significant unexplained heterogeneity in outcomes that is likely accounted for by differences in intervention components and strategies. There is intense interest in conducting motivational interviewing (MI) informed brief interventions for risky alcohol use in medical settings, but little empirical information is available regarding which MI behavioral and interpersonal style components drive effectiveness.
Following promising efficacy trials from counseling applications, MI was translated into brief (5-15 minute) interactions and subjected to randomized controlled trial methodology. Lack of mixed-methods, Stage 1 treatment development is evidenced by our inability to provide consistent delineation of key intervention components and mechanisms of action. Variability in these factors is likely responsible for the wide variability in effects observed in meta-analyses of brief interventions. Many MI skills and behaviors require significant training and supervision and increased patient-provider interaction time. The field would benefit greatly from empirically-based Stage 1 treatment development and modeling studies to delineate the degree to which adding motivational interviewing components to brief intervention improves outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Advice | Active comparator | Behavioral: Brief AdviceThe brief advice protocol was designed by removing MI-consistent elements from the NIAAA Clinician's Guide. The protocol involves screening and assessment using the NIAAA pre-screen and single-question screen and assessing for quantity and frequency. Patients exceeding recommended limits receive feedback, information, and advice to cut down drinking to recommended levels. All patients are provided with a tip sheet on strategies for cutting down and encouraged to follow-up with a behavioral health provider with any questions or concerns. |
| NIAAA Clinician's Guide | Active comparator | Behavioral: NIAAA Clinician's GuideThe NIAAA brief intervention was adapted directly from the NIAAA publication "Helping Patients Who Drink Too Much: A Clinician's Guide". The protocol screens using the NIAAA pre-screen and single-questions. Patients exceeding recommended limits receive feedback, information, and advice to cut down. For patients unwilling to make a change, the clinician restates their concern, encourages self reflection by asking the patient about reasons to cut down on drinking and barriers to change, and reaffirms willingness to help. For patients willing to make a change, the clinician helps the patient develop a plan to cut down within maximum limits, agree on specific steps and strategies, and provides a tip sheet on strategies for cutting down. |
| Motivational Interviewing (MI) | Experimental | Behavioral: Motivational Interviewing (MI)The MI intervention condition was also adapted from the NIAAA Clinician's Guide, with additional modification to include elements of MI. Clinicians normalize Screening and Brief Intervention (SBI) and ask the patient's permission before discussing alcohol use. The NIAAA pre-screen and single-question screen are administered. Assessment of quantity, frequency, and Alcohol Use Disorder symptoms is done using open questions. The ask-tell-ask technique is used to share feedback and exchange information regarding U.S adult drinking patterns. For patients low in readiness to make a change, clinicians build readiness using structured MI tools. For patients high in readiness to change, the ask-tell-ask technique is used to explore strategies for cutting down and develop an action plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Brief Advice | Behavioural | Brief Advice |
| NIAAA Clinician's Guide | Behavioural | NIAAA Clinician's Guide |
| Motivational Interviewing (MI) | Behavioural | Motivational Interviewing (MI) |
Primary outcome
Number days Exceeded Recommended Drinking Limits
Time frame: 30 days
2 secondary outcomes
Drinks Per Drinking Day
Time frame: 30 days
Percent Days Abstinent
Time frame: 30 days
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 11 Oct 2018.
- Derived from this study: PubMed 29482632Hettema JE, Cockrell SA, Reeves A, Ingersoll KS, Lum PJ, Saitz R, Murray-Krezan CM, Carrejo VA. Development and differentiability of three brief interventions for risky alcohol use that include varying doses of motivational interviewing. Addict Sci Clin Pract. 2018 Feb 27;13(1):6. doi: 10.1186/s13722-017-0102-0.
- Individual participant dataSharing planned: No
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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.
Jennifer Hettema, PhD principal investigator
The University of New Mexico Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Advice, NIAAA Clinician's Guide and Motivational Interviewing (MI) in people with Alcohol Abuse, run by University of New Mexico 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?
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 11 Oct 2018. 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?
Number days Exceeded Recommended Drinking Limits (time frame: 30 days). 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 NCT02978027, 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 11 Oct 2018.