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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04026373
Other study ID # PRO00024745
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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