Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking
PACER
1 other identifier
interventional
197
1 country
1
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 31, 2022
August 1, 2022
2.3 years
July 7, 2020
August 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Daily Drinking Questionnaire
Measures frequency and quantity of alcohol consumption (scores range from 0 to unlimited) where lower scores indicate better outcomes
Measured over a 3 month frame, can be used to calculate weekly or daily consumption
Secondary Outcomes (4)
Distress tolerance scale
Measure authors Simons and Gaher do not specify; PACER will use 90 days
PACER Feasibility - participation
Participation is dichotomously recorded at each engagement opportunity through study completion (up to 8 months)
Rates of excessive drinking
30 days
CORE survey of substance use
30 days
Study Arms (3)
Yoga
ACTIVE COMPARATOR60 minute sessions of guided yoga in small group format
Distress Tolerance
ACTIVE COMPARATOR60 minutes sessions of guided didactic distress tolerance skill building in small group format
Treatment as Usual
NO INTERVENTIONThose recruited through Student Health and Wellness will complete the university standard BASICS intervention.
Interventions
1 hour didactic group format, to develop distress tolerance skills
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Students who are actively psychotic
- Students who have less than a year of on campus engagement expected before graduation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Connecticut
Storrs, Connecticut, 06269-0001, United States
Related Publications (1)
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: 32472486BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beth Russell, PhD
University of Connecticut
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 30, 2020
Study Start
August 1, 2020
Primary Completion
November 1, 2022
Study Completion
December 31, 2022
Last Updated
August 31, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share