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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026373
• Other study ID #: PRO00024745
• Status: Completed
• Phase: N/A
• Start date: March 8, 2016
• Est. completion date: October 17, 2018

Study information

• Verified date: July 2019
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 17, 2018
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychological Trauma
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• modified Prolonged Exposure

• Treatment as usual
May include consult to health psychology and any follow-up deemed appropriate

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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