Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking (PACER)
Primary Purpose
Alcohol Abuse
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Distress Tolerance
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Abuse focused on measuring emotion regulation, alcohol use, college students
Eligibility Criteria
Inclusion Criteria:
- Students who report levels of ER difficulties exceeding the mean reported scores on the Difficulties with Emotion Regulation Scale for college students
- Students who screen positive on first 3 items of the AUDIT (called the "AUDIT-C" on which a score of 4 or more for men or 3 or more for women is indicative of hazardous drinking)
- Students with a status as an enrolled student at UCONN with at least a year of on-campus engagement expected before graduation or a commitment to completing all study activities.
Exclusion Criteria:
- Students who are actively psychotic
- Students who have less than a year of on campus engagement expected before graduation.
Sites / Locations
- University of Connecticut
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Yoga
Distress Tolerance
Treatment as Usual
Arm Description
60 minute sessions of guided yoga in small group format
60 minutes sessions of guided didactic distress tolerance skill building in small group format
Those recruited through Student Health and Wellness will complete the university standard BASICS intervention.
Outcomes
Primary Outcome Measures
Daily Drinking Questionnaire
Measures frequency and quantity of alcohol consumption (scores range from 0 to unlimited) where lower scores indicate better outcomes
Secondary Outcome Measures
Distress tolerance scale
Measures individual's ability to maintain goal-directed behavior while distressed (scores range from 16 to 80) where higher scores indicate better outcomes
PACER Feasibility - participation
Participant participation rates (scores range from 0% to 100%) where higher scores indicate better outcomes
Rates of excessive drinking
Recent reports of heavy (5+ drinks ) in one sitting (scores range from 0 to unlimited) where lower scores indicate better outcomes
CORE survey of substance use
Core frequency measures of substance use from the list of substances, including alcohol, where lower scores indicate better outcomes
Full Information
NCT ID
NCT04492982
First Posted
July 7, 2020
Last Updated
August 29, 2022
Sponsor
University of Connecticut
1. Study Identification
Unique Protocol Identification Number
NCT04492982
Brief Title
Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking
Acronym
PACER
Official Title
Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking: A Randomized Controlled Trial to Establish Acceptability, Feasibility and Preliminary Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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:
Test feasibility/acceptability of two ER interventions among high-risk emerging adults by documenting rates of recruitment, retention, adherence, and satisfaction.
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
emotion regulation, alcohol use, college students
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Active Comparator
Arm Description
60 minute sessions of guided yoga in small group format
Arm Title
Distress Tolerance
Arm Type
Active Comparator
Arm Description
60 minutes sessions of guided didactic distress tolerance skill building in small group format
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Those recruited through Student Health and Wellness will complete the university standard BASICS intervention.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
1 hour of group format, guided yoga practice
Intervention Type
Behavioral
Intervention Name(s)
Distress Tolerance
Other Intervention Name(s)
PRISM (Promoting Resilience in Self-Management)
Intervention Description
1 hour didactic group format, to develop distress tolerance skills
Primary Outcome Measure Information:
Title
Daily Drinking Questionnaire
Description
Measures frequency and quantity of alcohol consumption (scores range from 0 to unlimited) where lower scores indicate better outcomes
Time Frame
Measured over a 3 month frame, can be used to calculate weekly or daily consumption
Secondary Outcome Measure Information:
Title
Distress tolerance scale
Description
Measures individual's ability to maintain goal-directed behavior while distressed (scores range from 16 to 80) where higher scores indicate better outcomes
Time Frame
Measure authors Simons and Gaher do not specify; PACER will use 90 days
Title
PACER Feasibility - participation
Description
Participant participation rates (scores range from 0% to 100%) where higher scores indicate better outcomes
Time Frame
Participation is dichotomously recorded at each engagement opportunity through study completion (up to 8 months)
Title
Rates of excessive drinking
Description
Recent reports of heavy (5+ drinks ) in one sitting (scores range from 0 to unlimited) where lower scores indicate better outcomes
Time Frame
30 days
Title
CORE survey of substance use
Description
Core frequency measures of substance use from the list of substances, including alcohol, where lower scores indicate better outcomes
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Students who report levels of ER difficulties exceeding the mean reported scores on the Difficulties with Emotion Regulation Scale for college students
Students who screen positive on first 3 items of the AUDIT (called the "AUDIT-C" on which a score of 4 or more for men or 3 or more for women is indicative of hazardous drinking)
Students with a status as an enrolled student at UCONN with at least a year of on-campus engagement expected before graduation or a commitment to completing all study activities.
Exclusion Criteria:
Students who are actively psychotic
Students who have less than a year of on campus engagement expected before graduation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Russell, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269-0001
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32472486
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.
Results Reference
background
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Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking
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