Prevention of Post Sexual Assault Stress

Posttraumatic Stress Disorder Clinical Trial

Official title:

Prevention of Postrape Drug Abuse: Replication Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430624
• Other study ID #: NCT023099
• Secondary ID: R01DA023099
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 6, 2011
• Last updated: April 21, 2015
• Start date: May 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Post assault outcomes include coping behaviors and PTSD symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 90 Years

Eligibility

Inclusion Criteria:

• Seeking medical care after recent sexual assault

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Drug Abuse
• Drug Use
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• PPRS
Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
• PIRI
Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	North Memorial Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of specific drug use	Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups	14 days	No
Primary	DAST-10	Past 12 months assessed at baseline, post assault at 6 months	Baseline and 6 months	No
Primary	AUDIT	Past 12 months assessed at baseline, post assault at 6 months	Baseline, 6 months	No
Secondary	PSS-SR	Measure of PTSD symptoms.	2 weeks	No