Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04492982
Status:
UNKNOWN
Last Update Posted:
2022-08-31
First Post:
2020-07-07
Brief Title:
Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking
Sponsor:
University of Connecticut
Organization:
University of Connecticut
Study Overview
Official Title:
Emotion Regulation Interventions for Preventing Collegiate Escalations in Drinking A Randomized Controlled Trial to Establish Acceptability Feasibility and Preliminary Efficacy
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACER
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 useabuse 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 useabuse ie 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 feasibilityacceptability 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 ie associations between participant retention and participant-rated acceptability and age gender family characteristicsdynamics 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
1 Test feasibilityacceptability 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 ie associations between participant retention and participant-rated acceptability and age gender family characteristicsdynamics 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None