<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02978027</url>
  </required_header>
  <id_info>
    <org_study_id>K23AA020865</org_study_id>
    <secondary_id>K23AA020865</secondary_id>
    <nct_id>NCT02978027</nct_id>
  </id_info>
  <brief_title>Mentored Research on Improving Alcohol Brief Interventions in Medical Settings</brief_title>
  <official_title>Mentored Research on Improving Alcohol Brief Interventions in Medical Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels.&#xD;
      More than 50% of alcohol health consequences occur in risky, non-dependent drinkers.&#xD;
      Increasing the efficacy and efficiency of brief interventions in medical setting could&#xD;
      significantly reduce the public health impacts of risky drinking. There is intense interest&#xD;
      in conducting motivational interviewing (MI) informed brief interventions for risky alcohol&#xD;
      use in medical settings, but little empirical information is available regarding which MI&#xD;
      behavioral and interpersonal style components drive effectiveness. The field would benefit&#xD;
      greatly from empirically-based Stage 1 treatment development and modeling studies to&#xD;
      delineate the degree to which adding motivational interviewing components to brief&#xD;
      intervention improves outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The NIAAA estimates that 16% (40 million) of adults in the US are drinking at unsafe levels,&#xD;
      placing them at risk for a variety of physical, mental health, and social consequences. More&#xD;
      than 50% of alcohol health consequences occur in risky, non-dependent drinkers. Increasing&#xD;
      the efficacy and efficiency of brief interventions in medical setting could significantly&#xD;
      reduce the public health impacts of risky drinking. Despite overall positive findings for&#xD;
      brief interventions, there are high levels of variability in effects, with meta-analyses&#xD;
      reporting significant unexplained heterogeneity in outcomes that is likely accounted for by&#xD;
      differences in intervention components and strategies. There is intense interest in&#xD;
      conducting motivational interviewing (MI) informed brief interventions for risky alcohol use&#xD;
      in medical settings, but little empirical information is available regarding which MI&#xD;
      behavioral and interpersonal style components drive effectiveness.&#xD;
&#xD;
      Following promising efficacy trials from counseling applications, MI was translated into&#xD;
      brief (5-15 minute) interactions and subjected to randomized controlled trial methodology.&#xD;
      Lack of mixed-methods, Stage 1 treatment development is evidenced by our inability to provide&#xD;
      consistent delineation of key intervention components and mechanisms of action. Variability&#xD;
      in these factors is likely responsible for the wide variability in effects observed in&#xD;
      meta-analyses of brief interventions. Many MI skills and behaviors require significant&#xD;
      training and supervision and increased patient-provider interaction time. The field would&#xD;
      benefit greatly from empirically-based Stage 1 treatment development and modeling studies to&#xD;
      delineate the degree to which adding motivational interviewing components to brief&#xD;
      intervention improves outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number days Exceeded Recommended Drinking Limits</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drinks Per Drinking Day</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Days Abstinent</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Alcohol Abuse</condition>
  <arm_group>
    <arm_group_label>Brief Advice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIAAA Clinician's Guide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The NIAAA brief intervention was adapted directly from the NIAAA publication &quot;Helping Patients Who Drink Too Much: A Clinician's Guide&quot;. 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Motivational Interviewing (MI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Advice</intervention_name>
    <arm_group_label>Brief Advice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>NIAAA Clinician's Guide</intervention_name>
    <arm_group_label>NIAAA Clinician's Guide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing (MI)</intervention_name>
    <arm_group_label>Motivational Interviewing (MI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: patient in University of New Mexico Family and Community Medicine&#xD;
        Clinic (e.g. Family Practice, Southeast Height, Northeast Height, University Clinic, South&#xD;
        Valley), positive NIAAA single question screen (&gt;0), AUDIT-C score &lt;7, &gt;18 years old,&#xD;
        ability to read and speak English, and willing to be contacted for follow-up.&#xD;
&#xD;
        Exclusion Criteria: active suicidality, incarceration, obvious cognitive impairment, unable&#xD;
        to provide informed consent, current involvement in an alcohol research study or people who&#xD;
        are specifically seeking help for alcohol problems, and pregnancy or intent to become&#xD;
        pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Hettema, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of New Mexico Health Sciences Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>motivational interviewing</keyword>
  <keyword>brief alcohol intervention in primary care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02978027
org study id: K23AA020865
secondary id: K23AA020865
nct id: NCT02978027
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Number days Exceeded Recommended Drinking Limits
time frame: 30 days
measure: Drinks Per Drinking Day
time frame: 30 days
measure: Percent Days Abstinent
time frame: 30 days
arm group label: Brief Advice
arm group type: Active Comparator
description: 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.
arm group label: NIAAA Clinician's Guide
arm group type: Active Comparator
description: 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.
arm group label: Motivational Interviewing (MI)
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Brief Advice
arm group label: Brief Advice
intervention type: Behavioral
intervention name: NIAAA Clinician's Guide
arm group label: NIAAA Clinician's Guide
intervention type: Behavioral
intervention name: Motivational Interviewing (MI)
arm group label: Motivational Interviewing (MI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Hettema, PhD
role: Principal Investigator
affiliation: The University of New Mexico Health Sciences Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
sharing ipd: No