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New program aims to curb drinking and sexual distress in trauma survivors

NCT ID NCT05599620

Symptom relief Sponsor: Lifespan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a behavioral program called AWARE for college women aged 18-24 who have experienced sexual trauma and drink heavily. The program includes individual and group sessions to reduce alcohol use, sexual distress, and risk of future assault. Researchers followed 86 participants for 4 months to see if the program helped compared to a waitlist group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AWARE behavioral intervention
What this could lead to
If it works, this could provide an effective program to help survivors of sexual trauma reduce harmful drinking and sexual distress.
What could go wrong
This is a small, early-stage study with only 86 participants, so results may not apply to everyone. The intervention is compared to a waitlist, not an active treatment, which limits conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

86 people

The number who actually took part.

Started

Feb 2023

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 24 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 or non-penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation, coercion, or force; 4. report exceeding the national recommended limits for daily drinking (4 or more for women) on one or more occasions in the past 6 months; 5. report past year sexual activity; 6. 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: 1. suicide risk on items from the Beck Depression Inventory; 2. screen positive on the Alcohol Use Withdrawal Checklist.

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Conditions

The condition(s) this trial relates to.

Alcohol Drinking physiological sexual disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use, unspecified Sexual assault Sexual dysfunction

Contacts and locations

Locations

  • Rhode Island Hospital

    Providence, Rhode Island, 02904, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.