Prevention of Post Sexual Assault Stress
Prevention of Postrape Drug Abuse: Replication Study
1 other identifier
interventional
245
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2009
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 6, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
April 13, 2016
CompletedApril 13, 2016
April 1, 2015
4.6 years
September 6, 2011
November 2, 2015
March 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Drug Abuse Screening Test (DAST-10)
total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months
6 months
Alcohol Use Disorders Identification Test (AUDIT)
Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months
6 months
Cigarettes (Estimated Number)
quantity in 14 days prior to 6 week, 3 month and 6 month follow-up
14 days preceding 6 week, 3 month and 6 month follow-up
Amount of Alcohol Use
estimated number of drinks during the 14 days prior to each follow-up assessment
14 days prior to 6 week, 3 month, 6 month follow-up
Marijuana Use Frequency
Number of days of use within the 14 days prior to follow-up assessment
14 days prior to 6 week, 3 month, 6 month follow-up
Secondary Outcomes (3)
Any Other Illicit Drug Use
14 days prior to 6 week, 3 month, 6 month follow-up
Non-medical Use of Prescription Drugs Frequency
14 days prior to 6 week, 3 month, 6 month follow-up
PTSD Symptom Scale Self-Report (PSS-SR)
2 weeks prior to 6 week, 3 month, 6 month followup
Study Arms (3)
PPRS video
EXPERIMENTALPrevention of post sexual assault stress
PIRI video
ACTIVE COMPARATORPleasant imagery and relaxation instruction
Standard care
NO INTERVENTIONTreatment as usual
Interventions
Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
Eligibility Criteria
You may qualify if:
- Seeking medical care after recent sexual assault
You may not qualify if:
- Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hennepin County Medical Center
Minneapolis, Minnesota, 55404, United States
North Memorial Medical Center
Minneapolis, Minnesota, 55422, United States
Related Publications (4)
O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
PMID: 37795783DERIVEDWalsh K, Gilmore AK, Jaffe AE, Frazier P, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. A preliminary examination of sexual and physical victimization 6 months after recent rape. Arch Womens Ment Health. 2023 Aug;26(4):495-501. doi: 10.1007/s00737-023-01335-y. Epub 2023 Jun 8.
PMID: 37286883DERIVEDWalsh K, Gilmore AK, Schumacher JA, Coffey SF, Frazier PA, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. Post-sexual assault cigarette smoking: Findings from a randomized clinical trial of a video-based intervention. Addict Behav. 2020 Jan;100:106121. doi: 10.1016/j.addbeh.2019.106121. Epub 2019 Sep 5.
PMID: 31622944DERIVEDGilmore AK, Walsh K, Frazier P, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. Prescription Opioid Misuse After a Recent Sexual Assault: A Randomized Clinical Trial of a Video Intervention. Am J Addict. 2019 Sep;28(5):376-381. doi: 10.1111/ajad.12922. Epub 2019 Jun 26.
PMID: 31242340DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Heidi Resnick, Ph.D.
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Heidi Resnick, Ph.D.
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2011
First Posted
September 8, 2011
Study Start
May 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 13, 2016
Results First Posted
April 13, 2016
Record last verified: 2015-04