Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-02 @ 5:30 AM
Study NCT ID:
NCT04582695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2020-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Intervention Following Sexual Assault
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23AA028055 | NIH | None | https://reporter.nih.gov/quic… | View |