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出境医 / 临床实验 / RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE March 8, 2016
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019) 		Clinician-Administered PTSD Scale [ Time Frame: Three months post-trauma ]
Total score and subscales (re-experiencing, avoidance, cognition/mood changes, and hyperarousal symptoms) will be examined
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
Official Title  ICMJE RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • Behavioral: modified Prolonged Exposure
  • Behavioral: Treatment as usual
    May include consult to health psychology and any follow-up deemed appropriate
Study Arms  ICMJE
  • Experimental: modified Prolonged Exposure
    Intervention: Behavioral: modified Prolonged Exposure
  • Active Comparator: Treatment as usual
    Intervention: Behavioral: Treatment as usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2019) 		74
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 17, 2018
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026373
Other Study ID Numbers  ICMJE PRO00024745
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sadie Larsen, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical College of Wisconsin
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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