Prevention of Post Sexual Assault Stress

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01430624
First received: September 6, 2011
Last updated: March 14, 2016
Last verified: April 2015
Results First Received: November 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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.
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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  
Number of Participants  
[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
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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 ( US NIH Grant/Contract Award Number )
Study First Received: September 6, 2011
Results First Received: November 2, 2015
Last Updated: March 14, 2016
Health Authority: United States: Institutional Review Board