Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

Sexual Dysfunction Clinical Trial

— AWARE  

Official title:

Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599620
• Other study ID #: R34AA028402
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: February 2024
• Source: Lifespan
• Contact: Lindsay Orchowski
• Phone: 4125592936
• Email: lindsay_orchowski[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization. The main questions it aims to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relatively to control, the 2- and 6-month follow-up produces reductions in the quantity/frequency of alcohol use and heavy drinking, sexual distress, and sex-related drinking motives, and sexual revictimization. Participants will engage in both individual and group based intervention for alcohol use, sexual distress, and sexual assault risk. Follow-up assessments are completed at 2- and 6-months following program completion. The intervention will be compared to a general health promotion control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

1. be between the ages of 18 and 24;

2. speak and comprehend English;

3. report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation or force;

4. report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month;

5. report past month sexual activity;

6. exceed the clinical cut point on the Female Sexual Functioning Index.

Exclusion Criteria:

1. suicide risk on the Beck Depression Inventory;

2. screen positive on the Alcohol Use Withdrawal Checklist.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified
• Sexual Assault
• Sexual Dysfunction

Intervention

Behavioral:
• AWARE
AWARE addresses alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization.
• General Health Promotion
General Health Promotion is an attention and dose matched intervention with no overlapping components with AWARE.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Lifespan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Use	The number of past month drinking days (Minmum = 0, Maximum = 30), average drinks per drinking day (Minmum = 0, Maximum = unspecificed), number of heavy drinking days (Minimum = 0, Maximum = 30), assessed via the Time Line Follow Back, with greater scores meaning worse outcomes.	Change from baseline alcohol use at 6 months.
Primary	Sexual Distress	Assessed via the Female Sexual Dysfunction Index, Minumum = 2, Maximum = 36 with higher scores meaning worse outcomes.	Change from overall levels of sexual dysfunction at 6 months.
Primary	Sexual Victimization	Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes.	Reductions in severity and frequency of victimization in comparison to control at 6 months.
Secondary	Sex-Related Drinking Motives	Assessed via 2 subscales of the Drinking Motives Questionnaire, Minimum = 8, Maximum	Change in sexual related drinking motives at 6 months.