Drug UsePhase 1/2NCT01622855
Acute Intervention to Reduce Distress Following Sexual Assault
A Phase 1/2 study testing PPRS in people with Drug Use and Drug Abuse, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 90 years, women only
- Conditions the study is for
- Drug Use, Drug Abuse, Posttraumatic Stress Disorder
- What is being tested?
- PPRS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to Sep 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 14 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
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29412
About this study
Official title: 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.
Read the 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.
- Conditions
- Drug Use, Drug Abuse, Posttraumatic Stress Disorder
- Being tested
- PPRS
- 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 psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.
| Study group | Role | What they receive |
|---|---|---|
| PPRS video | Experimental | Prevention of post sexual assault stress Receives: Behavioral: PPRS |
| Standard care | No intervention | Receipt of standard services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of specific drug use
Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups
Measured: 14 days
Secondary outcomes (2)
Specific Drug Abuse
Criteria for DSM-IV substance abuse based on structured interview
Measured: 1.5, 3, 6 months
PSS-SR
Measure of PTSD symptoms
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startMar 1997
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 442 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
- NCT01622855
- Sponsor's protocol ID
- NCT11158
- Other IDs
- R01DA011158
- Status last verified
- Apr 2015
- First submitted
- 15 Jun 2012
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-Rape Psychopathology and Drug Abuse
- ClinicalTrials.gov ID
- NCT01622855
- Acronym / sponsor ID
- NCT11158
- Conditions
- Drug Use, Drug Abuse, Posttraumatic Stress Disorder
- Keywords
- Rape, Secondary prevention, Intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 1997
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPRS video | Experimental | Behavioral: PPRSPrevention of post sexual assault stress |
| Standard care | No intervention | –Receipt of standard services |
Who may qualify
- Ages
- 14 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 (5 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 psycho-education and modeling of adaptive behavioral coping strategies for use post-assault. | Behavioural | PPRS video |
Primary outcome
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
2 secondary outcomes
Specific Drug Abuse
Time frame: 1.5, 3, 6 months
PSS-SR
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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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
1 site 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 in people with Drug Use and Drug Abuse, run by Medical University of South Carolina at 1 site 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 5 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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of specific drug use (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2015.