Phase 2
N=245
Prevention of Post Sexual Assault Stress
Drug Use · Drug Abuse · Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01430624 ↗Enrolled (actual)
245
Serious AEs
0.8%
Results posted
Apr 2016
Primary outcome: Primary: Drug Abuse Screening Test (DAST-10) — 1.97; 2.03; 1.18 units on a scale — p=.24
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PPRS (Behavioral); PIRI (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Medical University of South Carolina
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Abuse Screening Test (DAST-10) |
1.97; 2.03; 1.18 | .24 |
| PRIMARY Alcohol Use Disorders Identification Test (AUDIT) |
7.21; 7.53; 8.15 | .89 |
| PRIMARY Cigarettes (Estimated Number) |
49.94; 87.29; 118.04; 54.63; 67.73; 84.47 | .01 sig |
| PRIMARY Amount of Alcohol Use |
15.33; 13.92; 19.90; 8.29; 14.32; 11.49 | .63 |
| PRIMARY Marijuana Use Frequency |
1.98; 2.48; 2.12; 2.75; 1.39; 2.12 | .83 |
| SECONDARY Any Other Illicit Drug Use |
6; 0; 2; 4; 3; 2 | .37 |
| SECONDARY Non-medical Use of Prescription Drugs Frequency |
1.56; .08; .54; .81; .75; .16 | .012 sig |
| SECONDARY PTSD Symptom Scale Self-Report (PSS-SR) |
26.98; 29.07; 24.49; 23.98; 23.33; 21.70 | .15 |
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.
Eligibility Criteria
Inclusion Criteria
- Seeking medical care after recent sexual assault
Exclusion Criteria
- Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury
Data sourced from ClinicalTrials.gov (NCT01430624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.