NCT04582695

Early Intervention Following Sexual Assault

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of the proposed Stage IA/IB study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) symptoms among women who experienced a sexual assault within the past six weeks. The intervention will be tested in an open label trial to make final modifications to evaluate feasibility, acceptability, and preliminary efficacy of the five to six week integrated intervention with standardized repeated measures during a one-month follow-up. Next, a pilot randomized controlled trial will be conducted among 54 recent sexual assault victims to evaluate feasibility and preliminary efficacy in reducing AUD severity and PTSD symptoms. Ecological momentary assessments (EMA) will be used to assess alcohol use, craving, and affect during the five-week treatment phase.

Conditions

• Ptsd
• Alcohol Use Disorder
• Sexual Assault and Rape

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-15
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2020-10-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States