Prevention of Post Sexual Assault Stress

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01430624
First received: September 6, 2011
Last updated: March 14, 2016
Last verified: April 2015

September 6, 2011
March 14, 2016
May 2009
December 2013   (final data collection date for primary outcome measure)
  • Drug Abuse Screening Test (DAST-10) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months
  • Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months
  • Cigarettes (Estimated Number) [ Time Frame: 14 days preceding 6 week, 3 month and 6 month follow-up ] [ Designated as safety issue: No ]
    quantity in 14 days prior to 6 week, 3 month and 6 month follow-up
  • Amount of Alcohol Use [ Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up ] [ Designated as safety issue: No ]
    estimated number of drinks during the 14 days prior to each follow-up assessment
  • Marijuana Use Frequency [ Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up ] [ Designated as safety issue: No ]
    Number of days of use within the 14 days prior to follow-up assessment
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
Complete list of historical versions of study NCT01430624 on ClinicalTrials.gov Archive Site
  • Any Other Illicit Drug Use [ Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up ] [ Designated as safety issue: No ]
    Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up
  • Non-medical Use of Prescription Drugs Frequency [ Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up ] [ Designated as safety issue: No ]
    Number of days of use within the 14 days prior to follow-up assessment
  • PTSD Symptom Scale Self-Report (PSS-SR) [ Time Frame: 2 weeks prior to 6 week, 3 month, 6 month followup ] [ Designated as safety issue: No ]
    Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, 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.
 
Completed
245
December 2013
December 2013   (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   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01430624
R01DA023099, R01DA023099
No
Not Provided
Not Provided
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
April 2015

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