Back to resultsRAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
modified Prolonged Exposure
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic
Eligibility 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:
- have evidence of moderate to severe cognitive impairment secondary to trauma-related head injury,
- have self-inflicted injury,
- are more than 2 weeks post-trauma,
- do not meet the DSM-5 definition of a traumatic stressor for PTSD,
- screen positive for a current substance abuse problem ((i.e. intoxication and memory loss upon arrival or a current substance use diagnosis),
- are non-English speaking,
- are not medically stable,
- cannot identify a support person to attend a session with them
- do not score a 2 or more on the 5-item PTSD subscale of the 9-item screen.
Sites / Locations
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
modified Prolonged Exposure
Treatment as usual
Arm Description
Outcomes
Primary Outcome Measures
Clinician-Administered PTSD Scale
Total score will be examined. Range is 0 to 80, with higher scores indicating higher severity of PTSD symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT04026373
First Posted
July 16, 2019
Last Updated
July 18, 2019
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT04026373
Brief Title
RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
Official Title
RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 8, 2016 (Actual)
Primary Completion Date
October 17, 2018 (Actual)
Study Completion Date
October 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
modified Prolonged Exposure
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
modified Prolonged Exposure
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
May include consult to health psychology and any follow-up deemed appropriate
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale
Description
Total score will be examined. Range is 0 to 80, with higher scores indicating higher severity of PTSD symptoms.
Time Frame
Three months post-trauma
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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:
have evidence of moderate to severe cognitive impairment secondary to trauma-related head injury,
have self-inflicted injury,
are more than 2 weeks post-trauma,
do not meet the DSM-5 definition of a traumatic stressor for PTSD,
screen positive for a current substance abuse problem ((i.e. intoxication and memory loss upon arrival or a current substance use diagnosis),
are non-English speaking,
are not medically stable,
cannot identify a support person to attend a session with them
do not score a 2 or more on the 5-item PTSD subscale of the 9-item screen.
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33269808
Citation
Larsen SE, Hunt JC, Geier T, Heyrman K, Schumann N, Brandolino A, Timmer-Murillo S, Bergner C, Larson C, deRoon-Cassini TA. A Randomized Trial of Modified Prolonged Exposure to Prevent the Development of Posttraumatic Stress Disorder in Patients Hospitalized With Traumatic Injuries. J Trauma Stress. 2021 Feb;34(1):104-115. doi: 10.1002/jts.22580. Epub 2020 Aug 17.
Results Reference
derived
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RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
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