Prevention of Post Sexual Assault Stress

• ClinicalTrials.gov Identifier: NCT01430624
• Recruitment Status: Completed
• First Posted: September 8, 2011
• Results First Posted: April 13, 2016
• Last Update Posted: April 13, 2016
• Sponsor: Medical University of South Carolina
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Medical University of South Carolina

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.

Condition or disease	Intervention/treatment	Phase
Drug Use; Drug Abuse; Posttraumatic Stress Disorder	Behavioral: PPRS; Behavioral: PIRI	Phase 1; Phase 2

Detailed Description:

Post assault outcomes include coping behaviors and PTSD symptoms.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 245 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prevention of Postrape Drug Abuse: Replication Study
• Study Start Date: May 2009
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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 :

1. 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
2. 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
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 90 Years (Child, Adult, Older Adult)
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01430624
• Other Study ID Numbers: R01DA023099 ( U.S. NIH Grant/Contract ); R01DA023099 ( U.S. NIH Grant/Contract )
• First Posted: September 8, 2011
• 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:

Substance-Related Disorders; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders