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RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma

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. Identifier: NCT04026373
Recruitment Status : Completed
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Information provided by (Responsible Party):
Sadie Larsen, Medical College of Wisconsin

Brief Summary:
The investigators proposed to compare a modified Prolonged Exposure intervention to treatment as usual within a hospitalized injured trauma survivor sample, to determine with this intervention could prevent the development of PTSD.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: modified Prolonged Exposure Behavioral: Treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
Actual Study Start Date : March 8, 2016
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : October 17, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: modified Prolonged Exposure Behavioral: modified Prolonged Exposure
Active Comparator: Treatment as usual Behavioral: Treatment as usual
May include consult to health psychology and any follow-up deemed appropriate

Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale [ Time Frame: Three months post-trauma ]
    Total score will be examined. Range is 0 to 80, with higher scores indicating higher severity of PTSD symptoms.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All consecutive motor vehicle crash (MVC), industrial accident, and physical assault trauma survivors (i.e. victims of gunshot wounds, stab wounds), ages 18-75, to include both men and women, without evidence of serious cognitive impairment, admitted to the trauma surgery service at Froedtert Hospital beginning at the start of the funding period will be considered for recruitment.

Exclusion Criteria:

  • Individuals who:

    1. have evidence of moderate to severe cognitive impairment secondary to trauma-related head injury,
    2. have self-inflicted injury,
    3. are more than 2 weeks post-trauma,
    4. do not meet the DSM-5 definition of a traumatic stressor for PTSD,
    5. screen positive for a current substance abuse problem ((i.e. intoxication and memory loss upon arrival or a current substance use diagnosis),
    6. are non-English speaking,
    7. are not medically stable,
    8. cannot identify a support person to attend a session with them
    9. do not score a 2 or more on the 5-item PTSD subscale of the 9-item screen.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04026373

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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin

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Responsible Party: Sadie Larsen, Associate Professor, Medical College of Wisconsin Identifier: NCT04026373     History of Changes
Other Study ID Numbers: PRO00024745
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Psychological Trauma
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders