New therapy tackles PTSD and drinking after sexual assault
NCT ID NCT04582695
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tested a 5-week behavioral therapy for women who experienced sexual assault and use alcohol. The therapy combines writing about the trauma with skills to manage alcohol cravings. Researchers measured changes in drinking habits and PTSD symptoms. The goal is to see if early intervention can help both conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Written Exposure Therapy integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder
- What this could lead to
- If successful, this could provide an effective early intervention for women struggling with both PTSD and alcohol use after sexual assault.
- What could go wrong
- This is a small, early-stage study with only 60 participants and no control group, so results may not be generalizable. The therapy is intensive and may not work for everyone.
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
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60 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Feb 2026
- Lead sponsor
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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
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Female; any race or ethnicity; age 18 to 65 years old. * Sexual assault that occurred within the past 12 months. * Subjects must be able to comprehend English. * A score of 3 or greater on the Alcohol Use Disorders Identification Test (AUDIT-C) screen. * A score of 31 or greater on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5). Subjects may also meet criteria for an alcohol use disorder, previous history of posttraumatic stress disorder, mood disorder (except bipolar affective disorder, see Exclusion Criteria) or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive-compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD and PTSD (Norman et al., 2018; Zinzow et al., 2012). Subjects may meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for another substance use disorder if AUD is the primary substance of choice. * Must consent to complete all treatment and follow-up visits. Exclusion Criteria: * Lack of any memory of the sexual assault * Subjects meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a history of or current psychotic, bipolar, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient. * Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA). These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed. * Individuals considered an immediate suicide risk, with current suicidal ideation and intent. * Individuals who attempted suicide in the past month. These individuals will be referred directly for treatment. * Individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study. * Any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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