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OpenTrials
Completed

NCT Number: NCT04026373

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

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Modified prolonged exposure

Behavioral

Treatment as Usual

Behavioral

May include consult to health psychology and any follow-up deemed appropriate

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2019
Registry last updated
Jul 22, 2019

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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