RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2018
CompletedFirst Submitted
Initial submission to the registry
July 16, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedJuly 22, 2019
July 1, 2019
2.6 years
July 16, 2019
July 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinician-Administered PTSD Scale
Total score will be examined. Range is 0 to 80, with higher scores indicating higher severity of PTSD symptoms.
Three months post-trauma
Study Arms (2)
modified Prolonged Exposure
EXPERIMENTALTreatment as usual
ACTIVE COMPARATORInterventions
May include consult to health psychology and any follow-up deemed appropriate
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 33269808DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 16, 2019
First Posted
July 19, 2019
Study Start
March 8, 2016
Primary Completion
October 17, 2018
Study Completion
October 17, 2018
Last Updated
July 22, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share