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Completed

NCT Number: NCT05599620

Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma

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 4-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 4-months following program completion. The intervention is compared to a wait list control group who will have the opportunity to complete the program after completing the 4-month follow up.

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Key information

Conditions

Alcohol Use, Unspecified Alcohol Drinking Behavior Drinking Behavior Genital Diseases Sexual Assault Sexual Dysfunction Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02904, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be between the ages of 18 and 24;
  • speak and comprehend English;
  • report a history of attempted or completed penetrative or non-penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation, coercion, or force;
  • report exceeding the national recommended limits for daily drinking (4 or more for women) on one or more occasions in the past 6 months;
  • report past year sexual activity;
  • exceed the clinical cut point on the Female Sexual Functioning Index (score of 28.1 or lower) or exceed the cut point for the 13-item Female Sexual Distress Scale-Revised (score of 11 or higher)

Exclusion criteria

  • suicide risk on items from the Beck Depression Inventory;
  • screen positive on the Alcohol Use Withdrawal Checklist.

Treatment and study plan

AWARE

Behavioral

AWARE addresses alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization.

Primary outcomes

  1. Alcohol Use

    Time frame: Change from baseline alcohol use at 4 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.

  2. Sexual Distress

    Time frame: Change from overall levels of sexual dysfunction at 4 months.

    Assessed via the Female Sexual Dysfunction Index, Minimum = 2, Maximum = 36 with higher scores meaning worse outcomes, and the Female Sexual Distress Scale, Minimum = 0, Maximum = 52 with lower scores meaning worse outcomes.

  3. Sexual Victimization

    Time frame: Reductions in severity and frequency of victimization in comparison to control at 4 months.

    Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes.

Secondary outcomes

  1. Sex-Related Drinking Expectancies

    Time frame: Change in sexual related drinking expectancies at 4 months.

    Assessed via the Sex Related Alcohol Expectancies, Minimum = 14, Maximum = 70

Sponsors and collaborators

Lead sponsor

Lifespan

Other

Registry information

Acronym: AWARE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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