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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 months, 4 months, and 8 months; 17 months for participants in years 1-2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

alcohol consumption

alcohol-related problems

exceeding clinical cutoff of 8+ for hazardous/harmful drinking

+1 more

Secondary outcome measures

binge eating

depression

stress

Other outcome measures

alcohol violations on campus

coping-motivated drinking

delay discounting

+2 more

Trial 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of KansasLead Sponsor

147 Previous Clinical Trials

325,321 Total Patients Enrolled

1 Trials studying Depression

8 Patients Enrolled for Depression

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

800 Previous Clinical Trials

1,362,457 Total Patients Enrolled

25 Trials studying Depression

7,529 Patients Enrolled for Depression

Tera L Fazzino, PhDPrincipal InvestigatorUniversity of Kansas

Media Library

Behavioral Activation Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04038190 — Phase 2

Depression Research Study Groups: Standard Orientation Course, Behavioral Activation Course

Depression Clinical Trial 2023: Behavioral Activation Intervention Highlights & Side Effects. Trial Name: NCT04038190 — Phase 2

Behavioral Activation Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04038190 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being observed in this clinical trial?

"It is correct that the data on clinicaltrials.gov show that this trial is actively recruiting patients. The original posting for the trial was on September 5, 2019, and it was most recently updated on October 1, 2021. The trial is admitting 540 patients at 1 location."

Answered by AI

Are there any dangers associated with behavioral activation?

"While there is some evidence to support the safety of behavioral activation, it has not been proven effective and thus received a score of 2."

Answered by AI

Are there any unfilled positions in this clinical research?

"That is correct. The clinical trial is currently recruiting patients. Based on the information found on clinicaltrials.gov, the study was first posted on September 5th, 2019 and last edited on October 1st, 2021. There is a need for 540 participants at 1 site."

Answered by AI