Prevention of Post Sexual Assault Stress

Phase 1

Completed

• Conditions: Posttraumatic Stress Disorder; Drug Use; Drug Abuse
• Interventions: Behavioral: PPRS; Behavioral: PIRI

• Registration Number: NCT01430624
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The purpose of this study is to evaluate whether a brief intervention in video format, that includes education about reactions to assault and modeling of adaptive coping strategies, designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of sexual assault at the time of receipt of post assault medical care is associated with better post-assault outcomes as compared to a comparable length video that includes pleasant imagery and relaxation instruction or standard care.

Detailed Description

Post assault outcomes include coping behaviors and PTSD symptoms.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-08
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-04
• Results First Submitted: 2015-11-02
• Results First Submitted QC: 2016-03-14
• Last Update Submitted: 2016-03-14
• Results First Posted: 2016-04-13
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 245

Inclusion Criteria

• Seeking medical care after recent sexual assault

Exclusion Criteria

• Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPRS video	PPRS	Prevention of post sexual assault stress
PIRI video	PIRI	Pleasant imagery and relaxation instruction

Primary Outcome Measures

Name	Time	Method
Drug Abuse Screening Test (DAST-10)	6 months	total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months
Marijuana Use Frequency	14 days prior to 6 week, 3 month, 6 month follow-up	Number of days of use within the 14 days prior to follow-up assessment
Cigarettes (Estimated Number)	14 days preceding 6 week, 3 month and 6 month follow-up	quantity in 14 days prior to 6 week, 3 month and 6 month follow-up
Amount of Alcohol Use	14 days prior to 6 week, 3 month, 6 month follow-up	estimated number of drinks during the 14 days prior to each follow-up assessment
Alcohol Use Disorders Identification Test (AUDIT)	6 months	Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months

Secondary Outcome Measures

Name	Time	Method
Non-medical Use of Prescription Drugs Frequency	14 days prior to 6 week, 3 month, 6 month follow-up	Number of days of use within the 14 days prior to follow-up assessment
PTSD Symptom Scale Self-Report (PSS-SR)	2 weeks prior to 6 week, 3 month, 6 month followup	Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.
Any Other Illicit Drug Use	14 days prior to 6 week, 3 month, 6 month follow-up	Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up

Trial Locations

Locations (2)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

North Memorial Medical Center; 🇺🇸 Minneapolis, Minnesota, United States