Back to resultsPrevention of Post Sexual Assault Stress
Primary Purpose
Drug Use, Drug Abuse, Posttraumatic Stress Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PPRS
PIRI
Sponsored by
About this trial
This is an interventional prevention trial for Drug Use focused on measuring Rape, Secondary prevention, Intervention
Eligibility Criteria
Inclusion Criteria:
- Seeking medical care after recent sexual assault
Exclusion Criteria:
- Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury
Sites / Locations
- Hennepin County Medical Center
- North Memorial Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
PPRS video
PIRI video
Standard care
Arm Description
Prevention of post sexual assault stress
Pleasant imagery and relaxation instruction
Treatment as usual
Outcomes
Primary Outcome Measures
Drug Abuse Screening Test (DAST-10)
total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 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
Cigarettes (Estimated Number)
quantity in 14 days prior to 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
Marijuana Use Frequency
Number of days of use within the 14 days prior to follow-up assessment
Secondary Outcome Measures
Any Other Illicit Drug Use
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
Number of days of use within the 14 days prior to follow-up assessment
PTSD Symptom Scale Self-Report (PSS-SR)
Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.
Full Information
NCT ID
NCT01430624
First Posted
September 6, 2011
Last Updated
March 14, 2016
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01430624
Brief Title
Prevention of Post Sexual Assault Stress
Official Title
Prevention of Postrape Drug Abuse: Replication Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Post assault outcomes include coping behaviors and PTSD symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use, Drug Abuse, Posttraumatic Stress Disorder
Keywords
Rape, Secondary prevention, Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPRS video
Arm Type
Experimental
Arm Description
Prevention of post sexual assault stress
Arm Title
PIRI video
Arm Type
Active Comparator
Arm Description
Pleasant imagery and relaxation instruction
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
PPRS
Intervention Description
Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
Intervention Type
Behavioral
Intervention Name(s)
PIRI
Intervention Description
Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
Primary Outcome Measure Information:
Title
Drug Abuse Screening Test (DAST-10)
Description
total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months
Time Frame
6 months
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months
Time Frame
6 months
Title
Cigarettes (Estimated Number)
Description
quantity in 14 days prior to 6 week, 3 month and 6 month follow-up
Time Frame
14 days preceding 6 week, 3 month and 6 month follow-up
Title
Amount of Alcohol Use
Description
estimated number of drinks during the 14 days prior to each follow-up assessment
Time Frame
14 days prior to 6 week, 3 month, 6 month follow-up
Title
Marijuana Use Frequency
Description
Number of days of use within the 14 days prior to follow-up assessment
Time Frame
14 days prior to 6 week, 3 month, 6 month follow-up
Secondary Outcome Measure Information:
Title
Any Other Illicit Drug Use
Description
Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up
Time Frame
14 days prior to 6 week, 3 month, 6 month follow-up
Title
Non-medical Use of Prescription Drugs Frequency
Description
Number of days of use within the 14 days prior to follow-up assessment
Time Frame
14 days prior to 6 week, 3 month, 6 month follow-up
Title
PTSD Symptom Scale Self-Report (PSS-SR)
Description
Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.
Time Frame
2 weeks prior to 6 week, 3 month, 6 month followup
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Seeking medical care after recent sexual assault
Exclusion Criteria:
Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Resnick, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
North Memorial Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31622944
Citation
Walsh 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.
Results Reference
derived
PubMed Identifier
31242340
Citation
Gilmore 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.
Results Reference
derived
Learn more about this trial
Prevention of Post Sexual Assault Stress
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