Clinical trial NCT01430624: Prevention of Post Sexual Assault Stress
Official title: Prevention of Postrape Drug Abuse: Replication Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Drug Use
Drug Abuse
Posttraumatic Stress Disorder
Keywords: Rape
Secondary prevention
Intervention
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-09-08
Enrollment: 245
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Seeking medical care after recent sexual assault

Exclusion Criteria:

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

Primary outcomes:
measure: Drug Abuse Screening Test (DAST-10)
timeFrame: 6 months
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 6 months
measure: Cigarettes (Estimated Number)
timeFrame: 14 days preceding 6 week, 3 month and 6 month follow-up
measure: Amount of Alcohol Use
timeFrame: 14 days prior to 6 week, 3 month, 6 month follow-up
measure: Marijuana Use Frequency
timeFrame: 14 days prior to 6 week, 3 month, 6 month follow-up
Secondary outcomes:
measure: Any Other Illicit Drug Use
timeFrame: 14 days prior to 6 week, 3 month, 6 month follow-up
measure: Non-medical Use of Prescription Drugs Frequency
timeFrame: 14 days prior to 6 week, 3 month, 6 month follow-up
measure: PTSD Symptom Scale Self-Report (PSS-SR)
timeFrame: 2 weeks prior to 6 week, 3 month, 6 month followup
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: North Memorial Medical Center
state: Minnesota
Study officials:
affiliation: Medical University of South Carolina
name: Heidi Resnick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.