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Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence

Primary Purpose

PTSD, Stress, Psychological, Gunshot Wound

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening Tool for Relief of Trauma (START)
standard of care
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Survivors of gunshot wound presenting to the Emergency room and/or admitted as inpatient that are eligible for the Violence Prevention and Outreach Program (VPOP).

Exclusion Criteria:

  • Patients with severe traumatic brain injury
  • Children under the age of 18
  • Patients otherwise unable to give consent
  • Non-English speaking patients
  • Victims of sexual assault
  • Patients with history of a severe mental illness and/or those already undergoing treatment for a mental illness by a licensed professional.

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

START treatment

standard of care

Arm Description

Participants randomized into the treatment arm will receive the START intervention as described above alongside usual care from the VPOP staff

Those randomized to the control arm will receive the usual screening for PTSD and referral for outpatient services if warranted as well as usual care from VPOP staff.

Outcomes

Primary Outcome Measures

PTSD evaluation
Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C)
Change in PTSD evaluation test scores
Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) A decrease in PCL-C score greater than or equal to 5 points relative to controls.
Change PTSD evaluation test scores
Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) A decrease in PCL-C score greater than or equal to 5 points relative to controls.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2019
Last Updated
April 13, 2022
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03916614
Brief Title
Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence
Official Title
Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence:
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To test the hypothesis that adult individuals who are victims of gun violence will have decreased symptoms of post-traumatic stress after an individual-level intervention with the Screening and Tool for Awareness and Relief of Trauma (START).
Detailed Description
In response to the lack of targeted mental health intervention for gunshot wound survivors, the Screening and Tool for Awareness and Relief of Trauma (START) was developed for patients that come from communities with sustained and persistent trauma. It consists of six screening questions adapted from the validated Primary Care PTSD Screen,[30] with input from focus groups, surveys and in-depth interviews with victims of violence and in particular, boys and young men of color. START has been shown to be effective at decreasing symptoms of PTSD in a one-month follow-up, but it has not been piloted on recently injured victims of gun violence specifically nor has it been tested in a randomized control trial design. A better understanding of the utility of this tool and others like it in victims of violent crime for relief of symptoms of post-traumatic stress and prevention of PTSD would contribute to the larger body of literature on PTSD prevention for victims of gun violence while simultaneously addressing a major need in this community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Stress, Psychological, Gunshot Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
START treatment
Arm Type
Experimental
Arm Description
Participants randomized into the treatment arm will receive the START intervention as described above alongside usual care from the VPOP staff
Arm Title
standard of care
Arm Type
Active Comparator
Arm Description
Those randomized to the control arm will receive the usual screening for PTSD and referral for outpatient services if warranted as well as usual care from VPOP staff.
Intervention Type
Behavioral
Intervention Name(s)
Screening Tool for Relief of Trauma (START)
Intervention Description
The Screening and Tool for Awareness and Relief of Trauma (START) was developed for patients that come from communities with sustained and persistent trauma. It consists of six screening questions adapted from the validated Primary Care PTSD Screen,[30] with input from focus groups, surveys and in-depth interviews with victims of violence. The full START intervention requires 30-45 minutes of structured conversation at the end of which the participant leaves with a better understanding of trauma symptoms as well as on-the-spot instruction on a set of techniques designed to alleviate the symptoms of PTSD. Based on the results of their screening, the participant will be offered up to four techniques to alleviate their symptoms
Intervention Type
Behavioral
Intervention Name(s)
standard of care
Intervention Description
Screening for PTSD and referral for outpatient services if warranted as well as usual care from Violence Prevention and Outreach Program (VPOP) staff.
Primary Outcome Measure Information:
Title
PTSD evaluation
Description
Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C)
Time Frame
baseline
Title
Change in PTSD evaluation test scores
Description
Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) A decrease in PCL-C score greater than or equal to 5 points relative to controls.
Time Frame
12 weeks
Title
Change PTSD evaluation test scores
Description
Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) A decrease in PCL-C score greater than or equal to 5 points relative to controls.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Survivors of gunshot wound presenting to the Emergency room and/or admitted as inpatient that are eligible for the Violence Prevention and Outreach Program (VPOP). Exclusion Criteria: Patients with severe traumatic brain injury Children under the age of 18 Patients otherwise unable to give consent Non-English speaking patients Victims of sexual assault Patients with history of a severe mental illness and/or those already undergoing treatment for a mental illness by a licensed professional.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Dodington, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence

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