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OpenTrials
Completed

NCT Number: NCT01430624

Prevention of Post Sexual Assault Stress

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.

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Key information

Conditions

Drug Use Chemically-Induced Disorders Drug Abuse Mental Disorders Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

15 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hennepin County Medical Center, Minneapolis, Minnesota, United States

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About this study

Post assault outcomes include coping behaviors and PTSD symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Seeking medical care after recent sexual assault

Exclusion criteria

  • Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury

Treatment and study plan

PPRS

Behavioral

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

PIRI

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Any Other Illicit Drug Use

    Time frame: 14 days prior to 6 week, 3 month, 6 month follow-up

    Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up

  2. Non-medical Use of Prescription Drugs 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. PTSD Symptom Scale Self-Report (PSS-SR)

    Time frame: 2 weeks prior to 6 week, 3 month, 6 month followup

    Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Prevention of Postrape Drug Abuse: Replication Study

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 8, 2011
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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