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Prevention of Post Sexual Assault Stress

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430624
First Posted: September 8, 2011
Last Update Posted: April 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina
Results First Submitted: November 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Drug Use
Drug Abuse
Posttraumatic Stress Disorder
Interventions: Behavioral: PPRS
Behavioral: PIRI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PPRS Video

Prevention of post sexual assault stress

PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.

PIRI Video

Pleasant imagery and relaxation instruction

PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.

Standard Care Treatment as usual

Participant Flow:   Overall Study
    PPRS Video   PIRI Video   Standard Care
STARTED   82 [1]   82   81 
Eligible Baseline Completes   77   77   79 
COMPLETED   54 [2]   48 [2]   52 [2] 
NOT COMPLETED   28   34   29 
Lost to Follow-up                23                29                27 
technical or eligibility                5                5                2 
[1] Initial potential eligible screened enrolled
[2] Completed one or more follow-ups



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PPRS (Completing Baseline) Prevention of Post-Sexual Assault Stress
PIRI (Completing Baseline) Pleasant Imagery and Relaxation Instruction
Standard Care (Completing Baseline) Standard Care Condition completing baseline
Total Total of all reporting groups

Baseline Measures
   PPRS (Completing Baseline)   PIRI (Completing Baseline)   Standard Care (Completing Baseline)   Total 
Overall Participants Analyzed 
[Units: Participants]
 77   77   79   233 
Age 
[Units: Participants]
       
<=18 years   3   5   2   10 
Between 18 and 65 years   74   72   77   223 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.79  (8.22)   27.99  (10.77)   27.52  (10.01)   27.43  (9.70) 
Gender 
[Units: Participants]
       
Female   77   77   79   233 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   77   77   79   233 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Drug Abuse Screening Test (DAST-10)   [ Time Frame: 6 months ]

2.  Primary:   Alcohol Use Disorders Identification Test (AUDIT)   [ Time Frame: 6 months ]

3.  Primary:   Cigarettes (Estimated Number)   [ Time Frame: 14 days preceding 6 week, 3 month and 6 month follow-up ]

4.  Primary:   Amount of Alcohol Use   [ Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up ]

5.  Primary:   Marijuana Use Frequency   [ Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up ]

6.  Secondary:   Any Other Illicit Drug Use   [ Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up ]

7.  Secondary:   Non-medical Use of Prescription Drugs Frequency   [ Time Frame: 14 days prior to 6 week, 3 month, 6 month follow-up ]

8.  Secondary:   PTSD Symptom Scale Self-Report (PSS-SR)   [ Time Frame: 2 weeks prior to 6 week, 3 month, 6 month followup ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Heidi Resnick, Ph.D.
Organization: Medical University of South Carolina
phone: 843-792-2945
e-mail: resnickh@musc.edu



Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01430624     History of Changes
Other Study ID Numbers: R01DA023099 ( U.S. NIH Grant/Contract )
First Submitted: September 6, 2011
First Posted: September 8, 2011
Results First Submitted: November 2, 2015
Results First Posted: April 13, 2016
Last Update Posted: April 13, 2016