<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/NCT04492982</url>
  </required_header>
  <id_info>
    <org_study_id>1R34AA027455-01A1</org_study_id>
    <nct_id>NCT04492982</nct_id>
  </id_info>
  <brief_title>Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking</brief_title>
  <acronym>PACER</acronym>
  <official_title>Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking: A Randomized Controlled Trial to Establish Acceptability, Feasibility and Preliminary Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Connecticut</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Connecticut</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the most recent National Survey on Drug Use and Health (NSDUH), college aged respondents&#xD;
      between 18 and 25 years old reported the highest alcohol use rates (over 58%) as well as the&#xD;
      highest rates of binge drinking of any age group. High alcohol use/abuse in college students&#xD;
      is associated with myriad negative consequences, including fatal and nonfatal injuries and&#xD;
      overdoses, impaired academic and vocational performance, violence and other crime, legal&#xD;
      problems, unintended pregnancies and sexually transmitted diseases, and social problems. The&#xD;
      National Comorbidity Survey underscores that use initiated in this period is not just&#xD;
      experimental and recreational but may have lasting effects on consumption trajectories: For&#xD;
      the majority of adults diagnosed alcohol use disorders, onset occurred during emerging&#xD;
      adulthood. During this stage of development, vast changes in emotion regulation (ER) take&#xD;
      place, particularly age-related shifts in the strategies used to manage distress that may&#xD;
      lead to alcohol use/abuse (i.e., emotion suppression, inhibitory control, and cognitive&#xD;
      reappraisal. Substantial evidence suggests that deficits in ER are strongly related to&#xD;
      patterns of alcohol use in young adults. In particular, deficits in the self regulation of&#xD;
      discomfort and distress, called distress tolerance, predict alcohol use - specifically,&#xD;
      motivation and urgency for use, escalations in consumption, and the development of dependence&#xD;
      that may be indicative of alcohol use disorders. Emerging adults who turn to alcohol as a way&#xD;
      of coping with distressing emotions are most at risk for heavy alcohol use into adulthood and&#xD;
      more severe negative alcohol consequences. Given the variable effectiveness of existing&#xD;
      approaches for reducing college students' alcohol use, The investigators contend that&#xD;
      interventions may be differentially effective depending on individual characteristics. In&#xD;
      particular, students with difficulties in managing distress and discomfort may benefit from&#xD;
      more intensive interventions that promote effective ER compared to treatment as usual;&#xD;
      further, other background characteristics may predict the efficacy and acceptability of each&#xD;
      type of ER intervention. In this R34, investigators will test the acceptability/ feasibility&#xD;
      and preliminary efficacy of two complementary interventions (Yoga and Distress Tolerance) on&#xD;
      preventing alcohol use in a randomized controlled trial of 180 high-risk college students&#xD;
      relative to treatment as usual. Investigators will assess participants' alcohol use&#xD;
      (self-report and biomarker measures) and emotion regulation (ER) at baseline along with&#xD;
      physiological discomfort sensitivity and psychosocial predictors of treatment efficacy over&#xD;
      time, including a post-treatment follow-up. Study aims include:&#xD;
&#xD;
        1. Test feasibility/acceptability of two ER interventions among high-risk emerging adults&#xD;
           by documenting rates of recruitment, retention, adherence, and satisfaction.&#xD;
&#xD;
        2. Examine trends in intervention acceptability based on baseline characteristics (i.e.,&#xD;
           associations between participant retention and participant-rated acceptability and age,&#xD;
           gender, family characteristics/dynamics, and predispositions to discomfort tolerance).&#xD;
&#xD;
        3. Test preliminary efficacy of the ER interventions on measures of ER and alcohol use.&#xD;
           Hypothesis: Participants in both intervention groups will see greater improvements in ER&#xD;
           and alcohol use outcomes compared to the TAU control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2022</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily Drinking Questionnaire</measure>
    <time_frame>Measured over a 3 month frame, can be used to calculate weekly or daily consumption</time_frame>
    <description>Measures frequency and quantity of alcohol consumption (scores range from 0 to unlimited) where lower scores indicate better outcomes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distress tolerance scale</measure>
    <time_frame>Measure authors Simons and Gaher do not specify; PACER will use 90 days</time_frame>
    <description>Measures individual's ability to maintain goal-directed behavior while distressed (scores range from 16 to 80) where higher scores indicate better outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PACER Feasibility - participation</measure>
    <time_frame>Participation is dichotomously recorded at each engagement opportunity through study completion (up to 8 months)</time_frame>
    <description>Participant participation rates (scores range from 0% to 100%) where higher scores indicate better outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of excessive drinking</measure>
    <time_frame>30 days</time_frame>
    <description>Recent reports of heavy (5+ drinks ) in one sitting (scores range from 0 to unlimited) where lower scores indicate better outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CORE survey of substance use</measure>
    <time_frame>30 days</time_frame>
    <description>Core frequency measures of substance use from the list of substances, including alcohol, where lower scores indicate better outcomes</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Alcohol Abuse</condition>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>60 minute sessions of guided yoga in small group format</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Distress Tolerance</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>60 minutes sessions of guided didactic distress tolerance skill building in small group format</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those recruited through Student Health and Wellness will complete the university standard BASICS intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>1 hour of group format, guided yoga practice</description>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Distress Tolerance</intervention_name>
    <description>1 hour didactic group format, to develop distress tolerance skills</description>
    <arm_group_label>Distress Tolerance</arm_group_label>
    <other_name>PRISM (Promoting Resilience in Self-Management)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students who report levels of ER difficulties exceeding the mean reported scores on&#xD;
             the Difficulties with Emotion Regulation Scale for college students&#xD;
&#xD;
          -  Students who screen positive on first 3 items of the AUDIT (called the &quot;AUDIT-C&quot; on&#xD;
             which a score of 4 or more for men or 3 or more for women is indicative of hazardous&#xD;
             drinking)&#xD;
&#xD;
          -  Students with a status as an enrolled student at UCONN with at least a year of&#xD;
             on-campus engagement expected before graduation or a commitment to completing all&#xD;
             study activities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Students who are actively psychotic&#xD;
&#xD;
          -  Students who have less than a year of on campus engagement expected before graduation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beth Russell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Connecticut</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Connecticut</name>
      <address>
        <city>Storrs</city>
        <state>Connecticut</state>
        <zip>06269-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Park CL, Russell BS, Fendrich M, Finkelstein-Fox L, Hutchison M, Becker J. Americans' COVID-19 Stress, Coping, and Adherence to CDC Guidelines. J Gen Intern Med. 2020 Aug;35(8):2296-2303. doi: 10.1007/s11606-020-05898-9. Epub 2020 May 29.</citation>
    <PMID>32472486</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>August 29, 2022</last_update_submitted>
  <last_update_submitted_qc>August 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Connecticut</investigator_affiliation>
    <investigator_full_name>Beth Russell</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>emotion regulation</keyword>
  <keyword>alcohol use</keyword>
  <keyword>college students</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/NCT04492982
org study id: 1R34AA027455-01A1
nct id: NCT04492982
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the most recent National Survey on Drug Use and Health (NSDUH), college aged respondents
      between 18 and 25 years old reported the highest alcohol use rates (over 58%) as well as the
      highest rates of binge drinking of any age group. High alcohol use/abuse in college students
      is associated with myriad negative consequences, including fatal and nonfatal injuries and
      overdoses, impaired academic and vocational performance, violence and other crime, legal
      problems, unintended pregnancies and sexually transmitted diseases, and social problems. The
      National Comorbidity Survey underscores that use initiated in this period is not just
      experimental and recreational but may have lasting effects on consumption trajectories: For
      the majority of adults diagnosed alcohol use disorders, onset occurred during emerging
      adulthood. During this stage of development, vast changes in emotion regulation (ER) take
      place, particularly age-related shifts in the strategies used to manage distress that may
      lead to alcohol use/abuse (i.e., emotion suppression, inhibitory control, and cognitive
      reappraisal. Substantial evidence suggests that deficits in ER are strongly related to
      patterns of alcohol use in young adults. In particular, deficits in the self regulation of
      discomfort and distress, called distress tolerance, predict alcohol use - specifically,
      motivation and urgency for use, escalations in consumption, and the development of dependence
      that may be indicative of alcohol use disorders. Emerging adults who turn to alcohol as a way
      of coping with distressing emotions are most at risk for heavy alcohol use into adulthood and
      more severe negative alcohol consequences. Given the variable effectiveness of existing
      approaches for reducing college students' alcohol use, The investigators contend that
      interventions may be differentially effective depending on individual characteristics. In
      particular, students with difficulties in managing distress and discomfort may benefit from
      more intensive interventions that promote effective ER compared to treatment as usual;
      further, other background characteristics may predict the efficacy and acceptability of each
      type of ER intervention. In this R34, investigators will test the acceptability/ feasibility
      and preliminary efficacy of two complementary interventions (Yoga and Distress Tolerance) on
      preventing alcohol use in a randomized controlled trial of 180 high-risk college students
      relative to treatment as usual. Investigators will assess participants' alcohol use
      (self-report and biomarker measures) and emotion regulation (ER) at baseline along with
      physiological discomfort sensitivity and psychosocial predictors of treatment efficacy over
      time, including a post-treatment follow-up. Study aims include:

        1. Test feasibility/acceptability of two ER interventions among high-risk emerging adults
           by documenting rates of recruitment, retention, adherence, and satisfaction.

        2. Examine trends in intervention acceptability based on baseline characteristics (i.e.,
           associations between participant retention and participant-rated acceptability and age,
           gender, family characteristics/dynamics, and predispositions to discomfort tolerance).

        3. Test preliminary efficacy of the ER interventions on measures of ER and alcohol use.
           Hypothesis: Participants in both intervention groups will see greater improvements in ER
           and alcohol use outcomes compared to the TAU control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
measure: Daily Drinking Questionnaire
time frame: Measured over a 3 month frame, can be used to calculate weekly or daily consumption
description: Measures frequency and quantity of alcohol consumption (scores range from 0 to unlimited) where lower scores indicate better outcomes
measure: Distress tolerance scale
time frame: Measure authors Simons and Gaher do not specify; PACER will use 90 days
description: Measures individual's ability to maintain goal-directed behavior while distressed (scores range from 16 to 80) where higher scores indicate better outcomes
measure: PACER Feasibility - participation
time frame: Participation is dichotomously recorded at each engagement opportunity through study completion (up to 8 months)
description: Participant participation rates (scores range from 0% to 100%) where higher scores indicate better outcomes
measure: Rates of excessive drinking
time frame: 30 days
description: Recent reports of heavy (5+ drinks ) in one sitting (scores range from 0 to unlimited) where lower scores indicate better outcomes
measure: CORE survey of substance use
time frame: 30 days
description: Core frequency measures of substance use from the list of substances, including alcohol, where lower scores indicate better outcomes
arm group label: Yoga
arm group type: Active Comparator
description: 60 minute sessions of guided yoga in small group format
arm group label: Distress Tolerance
arm group type: Active Comparator
description: 60 minutes sessions of guided didactic distress tolerance skill building in small group format
arm group label: Treatment as Usual
arm group type: No Intervention
description: Those recruited through Student Health and Wellness will complete the university standard BASICS intervention.
intervention type: Behavioral
intervention name: Yoga
description: 1 hour of group format, guided yoga practice
arm group label: Yoga
intervention type: Behavioral
intervention name: Distress Tolerance
description: 1 hour didactic group format, to develop distress tolerance skills
arm group label: Distress Tolerance
other name: PRISM (Promoting Resilience in Self-Management)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Beth Russell, PhD
role: Principal Investigator
affiliation: University of Connecticut
facility: 
country: United States
citation: Park CL, Russell BS, Fendrich M, Finkelstein-Fox L, Hutchison M, Becker J. Americans' COVID-19 Stress, Coping, and Adherence to CDC Guidelines. J Gen Intern Med. 2020 Aug;35(8):2296-2303. doi: 10.1007/s11606-020-05898-9. Epub 2020 May 29.
PMID: 32472486
responsible party type: Principal Investigator
investigator affiliation: University of Connecticut
investigator full name: Beth Russell
investigator title: Associate Professor
mesh term: Alcoholism
sharing ipd: No