Prevention of Post Sexual Assault Stress

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01430624
First received: September 6, 2011
Last updated: February 6, 2014
Last verified: October 2012

September 6, 2011
February 6, 2014
May 2009
February 2014   (final data collection date for primary outcome measure)
  • Frequency of specific drug use [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups
  • DAST-10 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Past 12 months assessed at baseline, post assault at 6 months
  • AUDIT [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Past 12 months assessed at baseline, post assault at 6 months
Same as current
Complete list of historical versions of study NCT01430624 on ClinicalTrials.gov Archive Site
PSS-SR [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Measure of PTSD symptoms.
  • DAST-10 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Completed at 6 month follow-up.
  • AUDIT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Completed at 6 month follow-up.
  • PSS-SR [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Measure of PTSD symptoms.
Not Provided
Not Provided
 
Prevention of Post Sexual Assault Stress
Prevention of Postrape Drug Abuse: Replication Study

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.

Post assault outcomes include coping behaviors and PTSD symptoms.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Drug Use
  • Drug Abuse
  • Posttraumatic Stress Disorder
  • 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.
  • Behavioral: PIRI
    Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
  • Experimental: PPRS video
    Prevention of post sexual assault stress
    Intervention: Behavioral: PPRS
  • Active Comparator: PIRI video
    Pleasant imagery and relaxation instruction
    Intervention: Behavioral: PIRI
  • No Intervention: Standard care
    Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Seeking medical care after recent sexual assault

Exclusion Criteria:

  • Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury
Female
15 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01430624
NCT023099, R01DA023099
No
Medical University of South Carolina
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Principal Investigator: Heidi Resnick, Ph.D. Medical University of South Carolina
Medical University of South Carolina
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP