Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence
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|ClinicalTrials.gov Identifier: NCT03916614|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : February 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|PTSD Stress, Psychological Gunshot Wound||Behavioral: Screening Tool for Relief of Trauma (START) Behavioral: standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence:|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||June 2022|
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, 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.
- PTSD evaluation [ Time Frame: baseline ]Post Traumatic Stress Disorder Checklist - Civilian Version (PCL-C)
- Change in PTSD evaluation test scores [ Time Frame: 12 weeks ]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 [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916614
|Contact: Kathleen O'Neill, MDfirstname.lastname@example.org|
|United States, Connecticut|
|Yale New Haven Hospital||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Kathleen O'Neill 410-530-4221 email@example.com|
|Principal Investigator:||James Dodington, MD||Yale University|