Acute Intervention to Reduce Distress Following Sexual Assault

Posttraumatic Stress Disorder Clinical Trial

Official title:

Prevention of Post-Rape Psychopathology and Drug Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622855
• Other study ID #: NCT11158
• Secondary ID: R01DA011158
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 15, 2012
• Last updated: April 21, 2015
• Start date: March 1997
• Est. completion date: September 2005

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 was to evaluate whether a brief intervention in video format delivered in the post assault medical exam setting and including education about assault reactions and instruction in and modeling of successful coping strategies would reduce post assault drug use or abuse and PTSD symptoms as compared to standard care.

Description:

The intervention being evaluated was shown at the time of the post assault medical exam and includes two main components: preparation for the medical exam; and information about and modelling of coping strategies that may help women cope in the aftermath of assault. The intervention content is delivered via video. Intervention and standard care groups were compared with regard to measures of substance use and abuse and symptoms of PTSD and other potentially comorbid problems including symptoms of depression or other anxiety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 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 psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

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
Secondary	Specific Drug Abuse	Criteria for DSM-IV substance abuse based on structured interview	1.5, 3, 6 months	No
Secondary	PSS-SR	Measure of PTSD symptoms	2 weeks	No