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Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking (PACER)

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University of Connecticut

Status

Active, not recruiting

Conditions

Alcohol Abuse

Treatments

Behavioral: Distress Tolerance
Behavioral: Yoga

Study type

Interventional

Funder types

Other

Identifiers

NCT04492982
1R34AA027455-01A1

Details and patient eligibility

About

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.

Enrollment

197 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

197 participants in 3 patient groups

Yoga
Active Comparator group
Description:
60 minute sessions of guided yoga in small group format
Treatment:
Behavioral: Yoga
Distress Tolerance
Active Comparator group
Description:
60 minutes sessions of guided didactic distress tolerance skill building in small group format
Treatment:
Behavioral: Distress Tolerance
Treatment as Usual
No Intervention group
Description:
Those recruited through Student Health and Wellness will complete the university standard BASICS intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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