Behavioral treatment for women after sexual assault
Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault
This study is testing a five-week treatment program to help women who have recently experienced sexual assault and are struggling with alcohol use and PTSD symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT04582695 on ClinicalTrials.gov |
What this trial studies
This study focuses on women who have experienced a sexual assault within the past six weeks and are dealing with alcohol use issues. It involves a five-week behavioral treatment program aimed at reducing symptoms of posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD). Participants will engage in an integrated cognitive-behavioral intervention, complete surveys during visits, and may also provide daily assessments via smartphone. The study aims to evaluate the feasibility and preliminary efficacy of this intervention through an open-label trial followed by a pilot randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 65 who have experienced a sexual assault within the past 12 months and exhibit symptoms of PTSD and alcohol use disorder.
Not a fit: Patients who do not meet the inclusion criteria, such as those who have not experienced a recent sexual assault or do not have symptoms of PTSD or alcohol use disorder, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce PTSD symptoms and alcohol use in women who have recently experienced sexual assault.
How similar studies have performed: Other studies have shown promise in using integrated cognitive-behavioral approaches for treating PTSD and alcohol use disorder, suggesting potential success for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Christine K Hahn, PhD
- Email: hahnc@musc.edu
- Phone: 262 297 2979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.