Early Intervention Following Sexual Assault

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Oct 5, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how to help women who have experienced a sexual assault in the past six weeks and who are also using alcohol. The aim is to provide a five-week behavioral treatment to support their mental health and reduce alcohol use. Women aged 18 to 65 who speak English, have had a recent sexual assault, and show signs of post-traumatic stress disorder (PTSD) and alcohol use disorder may be eligible to participate.

Participants in the study will attend visits where they’ll complete surveys about their experiences and feelings. They may also need to fill out short daily assessments on their smartphones. It’s important to note that women with certain severe mental health issues or immediate risks, such as suicidal thoughts or significant withdrawal symptoms from alcohol, cannot join the trial. Overall, this study aims to provide valuable support and treatment for women facing these challenges in a safe and understanding environment.

Gender

FEMALE

Eligibility 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.