Drug UsePhase 1/2NCT01430624
Prevention of Post Sexual Assault Stress
A Phase 1/2 study testing PPRS and PIRI in people with Drug Use and Drug Abuse, run by Medical University of South Carolina at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 90 years, women only
- Conditions the study is for
- Drug Use, Drug Abuse, Posttraumatic Stress Disorder
- What is being tested?
- PPRS and PIRI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Dec 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Seeking medical care after recent sexual assault
Who cannot join
- Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hennepin County Medical Center
Minneapolis, Minnesota, 55404
North Memorial Medical Center
Minneapolis, Minnesota, 55422
About this study
Official title: Prevention of Postrape Drug Abuse: Replication Study
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.
Read the detailed description
Post assault outcomes include coping behaviors and PTSD symptoms.
- Conditions
- Drug Use, Drug Abuse, Posttraumatic Stress Disorder
- Being tested
- PPRS, PIRI
- Keywords
- Rape, Secondary prevention, Intervention
- Medical subject headings
- Substance-Related Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPRSBehavioural
Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
PIRIBehavioural
Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
| Study group | Role | What they receive |
|---|---|---|
| PPRS video | Experimental | Prevention of post sexual assault stress Receives: Behavioral: PPRS |
| PIRI video | Active comparator | Pleasant imagery and relaxation instruction Receives: Behavioral: PIRI |
| Standard care | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Abuse Screening Test (DAST-10)
total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months
Measured: 6 months
Alcohol Use Disorders Identification Test (AUDIT)
Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months
Measured: 6 months
Cigarettes (Estimated Number)
quantity in 14 days prior to 6 week, 3 month and 6 month follow-up
Measured: 14 days preceding 6 week, 3 month and 6 month follow-up
Amount of Alcohol Use
estimated number of drinks during the 14 days prior to each follow-up assessment
Measured: 14 days prior to 6 week, 3 month, 6 month follow-up
Marijuana Use Frequency
Number of days of use within the 14 days prior to follow-up assessment
Measured: 14 days prior to 6 week, 3 month, 6 month follow-up
Secondary outcomes (3)
Any Other Illicit Drug Use
Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up
Measured: 14 days prior to 6 week, 3 month, 6 month follow-up
Non-medical Use of Prescription Drugs Frequency
Number of days of use within the 14 days prior to follow-up assessment
Measured: 14 days prior to 6 week, 3 month, 6 month follow-up
PTSD Symptom Scale Self-Report (PSS-SR)
Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.
Measured: 2 weeks prior to 6 week, 3 month, 6 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startMay 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Heidi Resnick, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430624
- Sponsor's protocol ID
- R01DA023099
- Other IDs
- R01DA023099
- Status last verified
- Apr 2015
- First submitted
- 6 Sep 2011
- Last updated
- 13 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
PubMed 37795783Walsh K, Gilmore AK, Jaffe AE, Frazier P, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. A preliminary examination of sexual and physical victimization 6 months after recent rape. Arch Womens Ment Health. 2023 Aug;26(4):495-501. doi: 10.1007/s00737-023-01335-y. Epub 2023 Jun 8.
PubMed 37286883Walsh 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.
PubMed 31622944Gilmore 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.
PubMed 31242340
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postrape Drug Abuse: Replication Study
- ClinicalTrials.gov ID
- NCT01430624
- Acronym / sponsor ID
- R01DA023099
- Conditions
- Drug Use, Drug Abuse, Posttraumatic Stress Disorder
- Keywords
- Rape, Secondary prevention, Intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Posted 13 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PPRS video | Experimental | Behavioral: PPRSPrevention of post sexual assault stress |
| PIRI video | Active comparator | Behavioral: PIRIPleasant imagery and relaxation instruction |
| Standard care | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Seeking medical care after recent sexual assault
Key exclusion criteria (1 listed)
- Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPRSVideo including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam. | Behavioural | PPRS video |
| PIRIVideo containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam. | Behavioural | PIRI video |
Primary outcome
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
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
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
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
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
3 secondary outcomes
Any Other Illicit Drug Use
Time frame: 14 days prior to 6 week, 3 month, 6 month follow-up
Non-medical Use of Prescription Drugs Frequency
Time frame: 14 days prior to 6 week, 3 month, 6 month follow-up
PTSD Symptom Scale Self-Report (PSS-SR)
Time frame: 2 weeks prior to 6 week, 3 month, 6 month followup
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37795783O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
- Derived from this study: PubMed 37286883Walsh K, Gilmore AK, Jaffe AE, Frazier P, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. A preliminary examination of sexual and physical victimization 6 months after recent rape. Arch Womens Ment Health. 2023 Aug;26(4):495-501. doi: 10.1007/s00737-023-01335-y. Epub 2023 Jun 8.
- Derived from this study: PubMed 31622944Walsh 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.
- Derived from this study: PubMed 31242340Gilmore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Resnick, Ph.D. principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PPRS and PIRI in people with Drug Use and Drug Abuse, run by Medical University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Abuse Screening Test (DAST-10) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01430624, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.