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

NCT03916614 | Completed

• 1 other identifier: 2000025580
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

PTSD; Stress, Psychological; Gunshot Wound

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

START treatment

EXPERIMENTAL

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)

standard of care

ACTIVE COMPARATOR

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

Interventions

Screening Tool for Relief of Trauma (START) BEHAVIORAL

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

START treatment

standard of care BEHAVIORAL

Screening for PTSD and referral for outpatient services if warranted as well as usual care from Violence Prevention and Outreach Program (VPOP) staff.

standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• O'Neill KM, Schenck C, Vega P, Gawel M, Dodington J. A pilot clinical trial of the Screening and Tool for Awareness and Relief of Trauma for survivors of gun violence. J Trauma Acute Care Surg. 2024 Apr 1;96(4):641-649. doi: 10.1097/TA.0000000000004121. Epub 2023 Aug 21.

  PMID: 37602906 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress, Psychological; Wounds, Gunshot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Wounds, Penetrating; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• James Dodington, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

US (1)