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AWARE Program for Survivors of Sexual Trauma (AWARE Trial)

N/A
Recruiting
Research Sponsored by Lifespan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up reductions in severity and frequency of victimization in comparison to control at 6 months.

Summary

This trial aims to develop a program to reduce alcohol use, sexual distress & sexual assault risk among college women who have been victimized. The intervention will be compared to a general health promotion control. Follow-up assessments will be conducted 2 & 6 months after program completion.

Who is the study for?
This trial is for college women aged 18-24 who speak English and have experienced sexual victimization since age 14. They must also report heavy drinking twice or more in the past month, be sexually active, and show signs of sexual distress. Women at suicide risk or with alcohol withdrawal symptoms cannot participate.
What is being tested?
The study tests an intervention called AWARE aimed at reducing alcohol use, alleviating sexual distress, and lowering the risk of further sexual assault compared to a general health promotion program. Participants will receive individual and group sessions with follow-ups at 2 and 6 months after completion.
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, there are no direct side effects like those seen with drugs. However, discussing sensitive topics may cause emotional discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in sexual related drinking motives at 6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in sexual related drinking motives at 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alcohol Use Disorder
Sexual Distress
Sexual Victimization
Secondary study objectives
Sex-Related Drinking Motives

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AWARE ProgramExperimental Treatment1 Intervention
The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.
Group II: General Health PromotionPlacebo Group1 Intervention
The General Health Promotion program is a attention and dose-matched comparison condition.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AWARE
2018
N/A
~280

Find a Location

Who is running the clinical trial?

LifespanLead Sponsor
40 Previous Clinical Trials
40,982 Total Patients Enrolled

Media Library

AWARE Clinical Trial Eligibility Overview. Trial Name: NCT05599620 — N/A
Sexual Dysfunction Research Study Groups: AWARE Program, General Health Promotion
Sexual Dysfunction Clinical Trial 2023: AWARE Highlights & Side Effects. Trial Name: NCT05599620 — N/A
AWARE 2023 Treatment Timeline for Medical Study. Trial Name: NCT05599620 — N/A
~36 spots leftby Apr 2026
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