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Behavioral Activation for Alcohol Use Disorder
Phase 2
Recruiting
Led By Tera L Fazzino, PhD
Research Sponsored by University of Kansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 months, 4 months, and 8 months; 17 months for participants in years 1-2
Awards & highlights
Summary
This trial will test a new way to help college freshmen who drink too much alcohol. The intervention will address concerns that are most relevant to these students and be integrated into the college curriculum.
Who is the study for?
This trial is for college freshmen enrolled in UNIV 101 freshman seminar courses at the University of Kansas. It's designed to help students who are transitioning from high school to college and might be facing increased stress, which can lead to risky behaviors like heavy drinking or eating disorders.
What is being tested?
The study is testing a behavioral activation intervention integrated into the college curriculum. This approach aims to reduce alcohol use and related issues by focusing on concerns relevant to new college students rather than directly targeting alcohol consumption itself.
What are the potential side effects?
Since this is a behavioral intervention focused on activities and strategies within a classroom setting, traditional medical side effects are not applicable. However, participants may experience emotional discomfort when discussing personal issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 months, 4 months, and 8 months; 17 months for participants in years 1-2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 months, 4 months, and 8 months; 17 months for participants in years 1-2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
alcohol consumption
alcohol-related problems
exceeding clinical cutoff of 8+ for hazardous/harmful drinking
+1 moreSecondary study objectives
binge eating
depression
stress
Other study objectives
alcohol violations on campus
coping-motivated drinking
delay discounting
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Activation CourseExperimental Treatment1 Intervention
Behavioral activation course condition administered in a college freshman orientation seminar
Group II: Standard Orientation CourseActive Control1 Intervention
Standard freshman orientation seminar course condition
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
behavioral activation
2016
N/A
~80
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Who is running the clinical trial?
University of KansasLead Sponsor
150 Previous Clinical Trials
326,179 Total Patients Enrolled
1 Trials studying Depression
8 Patients Enrolled for Depression
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
823 Previous Clinical Trials
1,160,766 Total Patients Enrolled
26 Trials studying Depression
7,636 Patients Enrolled for Depression
Tera L Fazzino, PhDPrincipal InvestigatorUniversity of Kansas
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Not applicable.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Orientation Course
- Group 2: Behavioral Activation Course
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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