Acute Intervention to Reduce Distress Following Sexual Assault
Primary Purpose
Drug Use, Drug Abuse, Posttraumatic Stress Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PPRS
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
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PPRS video
Standard care
Arm Description
Prevention of post sexual assault stress
Receipt of standard services
Outcomes
Primary Outcome Measures
Frequency of specific drug use
Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups
Secondary Outcome Measures
Specific Drug Abuse
Criteria for DSM-IV substance abuse based on structured interview
PSS-SR
Measure of PTSD symptoms
Full Information
NCT ID
NCT01622855
First Posted
June 15, 2012
Last Updated
April 21, 2015
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01622855
Brief Title
Acute Intervention to Reduce Distress Following Sexual Assault
Official Title
Prevention of Post-Rape Psychopathology and Drug Abuse
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (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 was to evaluate whether a brief intervention in video format delivered in the post assault medical exam setting and including education about assault reactions and instruction in and modeling of successful coping strategies would reduce post assault drug use or abuse and PTSD symptoms as compared to standard care.
Detailed Description
The intervention being evaluated was shown at the time of the post assault medical exam and includes two main components: preparation for the medical exam; and information about and modelling of coping strategies that may help women cope in the aftermath of assault. The intervention content is delivered via video. Intervention and standard care groups were compared with regard to measures of substance use and abuse and symptoms of PTSD and other potentially comorbid problems including symptoms of depression or other anxiety.
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
442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPRS video
Arm Type
Experimental
Arm Description
Prevention of post sexual assault stress
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Receipt of standard services
Intervention Type
Behavioral
Intervention Name(s)
PPRS
Intervention Description
Video including psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.
Primary Outcome Measure Information:
Title
Frequency of specific drug use
Description
Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Specific Drug Abuse
Description
Criteria for DSM-IV substance abuse based on structured interview
Time Frame
1.5, 3, 6 months
Title
PSS-SR
Description
Measure of PTSD symptoms
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 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
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acute Intervention to Reduce Distress Following Sexual Assault
We'll reach out to this number within 24 hrs