Acute Intervention to Reduce Distress Following Sexual Assault

April 21, 2015 updated by: Medical University of South Carolina

Prevention of Post-Rape Psychopathology and Drug Abuse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

442

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 86 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Seeking medical care after recent sexual assault

Exclusion Criteria:

  • Active psychosis
  • Active suicidality
  • Cognitive impairment
  • Non-English speaking
  • Severe injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PPRS video
Prevention of post sexual assault stress
Behavioral: PPRS
Video including psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.
No Intervention: Standard care
Receipt of standard services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of specific drug use
Time Frame: 14 days
Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific Drug Abuse
Time Frame: 1.5, 3, 6 months
Criteria for DSM-IV substance abuse based on structured interview
1.5, 3, 6 months
PSS-SR
Time Frame: 2 weeks
Measure of PTSD symptoms
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Heidi Resnick, Ph.D., Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT11158
  • R01DA011158 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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