Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

Not Applicable

Recruiting

• Conditions: Sexual Dysfunction; Alcohol Use, Unspecified; Sexual Assault
• Interventions: Behavioral: AWARE; Behavioral: General Health Promotion

• Registration Number: NCT05599620
• Lead Sponsor: Lifespan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-10-31
• Study Start: 2023-02-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AWARE Program	AWARE	The AWARE program addresses alcohol use, sexual distress and sexual revictimization risk.
General Health Promotion	General Health Promotion	The General Health Promotion program is a attention and dose-matched comparison condition.

Primary Outcome Measures

Name	Time	Method
Alcohol Use	Change from baseline alcohol use at 6 months.	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.
Sexual Victimization	Reductions in severity and frequency of victimization in comparison to control at 6 months.	Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes.
Sexual Distress	Change from overall levels of sexual dysfunction at 6 months.	Assessed via the Female Sexual Dysfunction Index, Minumum = 2, Maximum = 36 with higher scores meaning worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Sex-Related Drinking Motives	Change in sexual related drinking motives at 6 months.	Assessed via 2 subscales of the Drinking Motives Questionnaire, Minimum = 8, Maximum

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States