Active — Not RecruitingNot Applicable

Early Intervention Following Sexual Assault

United States60 participantsStarted 2020-12-15

Plain-language summary

This study is for women who have experienced a sexual assault in the past six weeks and use alcohol. The research involves completing a five week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete brief daily assessments on their smart phones.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Change in Percent Drinking Days on The Time Line Follow-Back

Timeframe: Participants will report on drinking during the 30 days prior to initiation of the study, and every day until study completion completion of study visits, approximately six weeks.

Change in number of standard drinks per drinking day on The Time Line Follow-Back

Timeframe: Participants will report on drinking during the 30 days prior to initiation of the study, and ever day until completion of study visits, approximately six weeks.

Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5)

Timeframe: Baseline and after completion of study visits, approximately six weeks.

Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders

Timeframe: Baseline and after completion of study visits, approximately six weeks.

Trial details

NCT IDNCT04582695

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Ptsd trials