Alcohol AbusePACERNCT04492982
Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking
A study testing Yoga and Distress Tolerance in people with Alcohol Abuse, run by University of Connecticut at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Yoga and Distress Tolerance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Students who are actively psychotic
- Students who have less than a year of on campus engagement expected before graduation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269-0001
About this study
Official title: Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking: A Randomized Controlled Trial to Establish Acceptability, Feasibility and Preliminary Efficacy
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.
- Conditions
- Alcohol Abuse
- Being tested
- Yoga, Distress Tolerance
- Keywords
- emotion regulation, alcohol use, college students
- Medical subject headings
- Alcoholism, Emotional Regulation, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
1 hour of group format, guided yoga practice
Distress ToleranceBehavioural
Also called PRISM (Promoting Resilience in Self-Management)
1 hour didactic group format, to develop distress tolerance skills
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Active comparator | 60 minute sessions of guided yoga in small group format Receives: Behavioral: Yoga |
| Distress Tolerance | Active comparator | 60 minutes sessions of guided didactic distress tolerance skill building in small group format Receives: Behavioral: Distress Tolerance |
| Treatment as Usual | No intervention | Those recruited through Student Health and Wellness will complete the university standard BASICS intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Drinking Questionnaire
Measures frequency and quantity of alcohol consumption (scores range from 0 to unlimited) where lower scores indicate better outcomes
Measured: Measured over a 3 month frame, can be used to calculate weekly or daily consumption
Secondary outcomes (4)
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
Measured: Measure authors Simons and Gaher do not specify; PACER will use 90 days
PACER Feasibility - participation
Participant participation rates (scores range from 0% to 100%) where higher scores indicate better outcomes
Measured: Participation is dichotomously recorded at each engagement opportunity through study completion (up to 8 months)
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
Measured: 30 days
CORE survey of substance use
Core frequency measures of substance use from the list of substances, including alcohol, where lower scores indicate better outcomes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Aug 2020
- Primary completionNov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Russell, University of Connecticut
- Investigators
- Beth Russell, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492982
- Sponsor's protocol ID
- 1R34AA027455-01A1
- Acronym
- PACER
- Status last verified
- Aug 2022
- First submitted
- 7 Jul 2020
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32472486
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking: A Randomized Controlled Trial to Establish Acceptability, Feasibility and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT04492982
- Acronym / sponsor ID
- PACER / 1R34AA027455-01A1
- Conditions
- Alcohol Abuse
- Keywords
- emotion regulation, alcohol use, college students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga | Active comparator | Behavioral: Yoga60 minute sessions of guided yoga in small group format |
| Distress Tolerance | Active comparator | Behavioral: Distress Tolerance60 minutes sessions of guided didactic distress tolerance skill building in small group format |
| Treatment as Usual | No intervention | –Those recruited through Student Health and Wellness will complete the university standard BASICS intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Students who are actively psychotic
- Students who have less than a year of on campus engagement expected before graduation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga1 hour of group format, guided yoga practice | Behavioural | Yoga |
| Distress ToleranceAlso: PRISM (Promoting Resilience in Self-Management)1 hour didactic group format, to develop distress tolerance skills | Behavioural | Distress Tolerance |
Primary outcome
Daily Drinking Questionnaire
Time frame: Measured over a 3 month frame, can be used to calculate weekly or daily consumption
Measures frequency and quantity of alcohol consumption (scores range from 0 to unlimited) where lower scores indicate better outcomes
4 secondary outcomes
Distress tolerance scale
Time frame: Measure authors Simons and Gaher do not specify; PACER will use 90 days
PACER Feasibility - participation
Time frame: Participation is dichotomously recorded at each engagement opportunity through study completion (up to 8 months)
Rates of excessive drinking
Time frame: 30 days
CORE survey of substance use
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Background: PubMed 32472486Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Russell, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Distress Tolerance in people with Alcohol Abuse, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Drinking Questionnaire (time frame: Measured over a 3 month frame, can be used to calculate weekly or daily consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022; AzTrials last refreshed its copy on 26 Oct 2026.