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ACTIVE NOT RECRUITING

NCT04582695

Early Intervention Following Sexual Assault

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

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.

Official title: Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-12-15

Completion Date

2026-03-31

Last Updated

2026-02-09

Healthy Volunteers

Conditions

Ptsd Alcohol Use Disorder Sexual Assault and Rape

Interventions

BEHAVIORAL

Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder

Participants will receive 5 to 6 weeks of an integrated behavioral therapy that address posttraumatic stress disorder and alcohol use disorder. Sessions will be 60 minutes in length. It will include written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes. In addition, they will receive 20 minutes of intervention focused on cognitive behavioral therapy for alcohol use disorder which involves learning skills to cope with alcohol cravings and behavior (e.g., challenging thoughts, problem solving).

BEHAVIORAL

Written Exposure Therapy

Participants will receive 5 to 6 weeks of written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes.

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States