Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking

Alcohol Abuse Clinical Trial

— PACER  

Official title:

Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking: A Randomized Controlled Trial to Establish Acceptability, Feasibility and Preliminary Efficacy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04492982
• Other study ID #: 1R34AA027455-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 197
• Est. completion date: December 31, 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

Intervention

Behavioral:
• Yoga
1 hour of group format, guided yoga practice
• Distress Tolerance
1 hour didactic group format, to develop distress tolerance skills

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Measure authors Simons and Gaher do not specify; PACER will use 90 days
Secondary	PACER Feasibility - participation	Participant participation rates (scores range from 0% to 100%) where higher scores indicate better outcomes	Participation is dichotomously recorded at each engagement opportunity through study completion (up to 8 months)
Secondary	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	30 days
Secondary	CORE survey of substance use	Core frequency measures of substance use from the list of substances, including alcohol, where lower scores indicate better outcomes	30 days