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

NCT ID: NCT04026373

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-08
• Study Completion Date: 2018-10-17

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

modified Prolonged Exposure

Group Type: EXPERIMENTAL

modified Prolonged Exposure

Intervention Type: BEHAVIORAL

Treatment as usual

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

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

Interventions

modified Prolonged Exposure

Intervention Type: BEHAVIORAL

Treatment as usual

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Sadie Larsen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33269808 (View on PubMed)

Other Identifiers

PRO00024745

Identifier Type: -

Identifier Source: org_study_id