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Prevention of Post Sexual Assault Stress

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430624
First Posted: September 8, 2011
Last Update Posted: April 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Postrape Drug Abuse: Replication Study

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

Primary Outcome Measures:
  • Drug Abuse Screening Test (DAST-10) [ Time Frame: 6 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    Number of days of use within the 14 days prior to follow-up assessment


Secondary Outcome Measures:
  • Any Other Illicit Drug Use [ Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up ]
    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 ]
    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 ]
    Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.


Enrollment: 245
Study Start Date: May 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01430624     History of Changes
Other Study ID Numbers: R01DA023099 ( U.S. NIH Grant/Contract )
First Submitted: September 6, 2011
First Posted: September 8, 2011
Results First Submitted: November 2, 2015
Results First Posted: April 13, 2016
Last Update Posted: April 13, 2016
Last Verified: April 2015

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders