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Prevention of Post Sexual Assault Stress

This study is enrolling participants by invitation only.
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: May 2, 2013
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Drug Use
Drug Abuse
Posttraumatic Stress Disorder
 Behavioral: PPRS
Behavioral: PIRI
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Postrape Drug Abuse: Replication Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • PSS-SR [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Measure of PTSD symptoms.


Estimated Enrollment: 300
Study Start Date: May 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PPRS video
Prevention of post sexual assault stress
 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.
Active Comparator: PIRI video
Pleasant imagery and relaxation instruction
 Behavioral: PIRI
Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
No Intervention: Standard care
Treatment as usual

Detailed Description:

Post assault outcomes include coping behaviors and PTSD symptoms.

  Eligibility

Ages Eligible for Study:   15 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Seeking medical care after recent sexual assault

Exclusion Criteria:

  • Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430624

Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55404
North Memorial Medical Center
Minneapolis, Minnesota, United States, 55422
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Heidi Resnick, Ph.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01430624     History of Changes
Other Study ID Numbers: NCT023099, R01DA023099
Study First Received: September 6, 2011
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Rape
Secondary prevention
Intervention

Additional relevant MeSH terms:
Substance-Related Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 23, 2013