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

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

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).

Study Overview

• Status: Completed
• Conditions: PTSD; Stress, Psychological; Gunshot Wound
• Intervention / Treatment: Behavioral: Screening Tool for Relief of Trauma (START); Behavioral: standard of care

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: START treatment; Participants randomized into the treatment arm will receive the START intervention as described above alongside usual care from the VPOP staff	Behavioral: Screening Tool for Relief of Trauma (START); 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
ACTIVE_COMPARATOR: standard of care; 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.	Behavioral: standard of care; Screening for PTSD and referral for outpatient services if warranted as well as usual care from Violence Prevention and Outreach Program (VPOP) staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD evaluation	Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C)	baseline
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.	12 weeks
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.	6 months

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: James Dodington, MD, Yale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): January 1, 2022
• Study Completion (ACTUAL): January 1, 2022

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (ACTUAL): April 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Wounds and Injuries; Wounds, Penetrating; Stress, Psychological; Wounds, Gunshot
• Other Study ID Numbers: 2000025580

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No