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

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Behavioral: Treatment as usual; Behavioral: modified Prolonged Exposure

• Registration Number: NCT04026373
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-08
• Primary Completion: 2018-10-17
• Study Completion: 2018-10-17
• Status Verified: 2019-07
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-18
• Last Update Submitted: 2019-07-18
• Study First Posted: 2019-07-19
• Last Update Posted: 2019-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Treatment as usual	-
modified Prolonged Exposure	modified Prolonged Exposure	-

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale	Three months post-trauma	Total score will be examined. Range is 0 to 80, with higher scores indicating higher severity of PTSD symptoms.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States