Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06876740

Conditions

PTSD

Firearm Injury

Suicide Prevention

Firearm Safety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Project Safe Guard - Trauma

Project Safe Guard

Study Details

Brief summary:

The goal of this randomized controlled trial is to determine if a counseling intervention, Project Safe Guard-Trauma (PSG-T), increases secure firearm storage practices in adults who screen positive for posttraumatic stress disorder (PTSD). The main questions this study aims to answer are:

  • Does PSG-T lead to more secure firearm storage practices?
  • Does PSG-T increase knowledge about the link between firearm storage practices and suicide risk?
  • Does PSG-T increase intentions to store firearms securely?

Researchers will compare PSG-T to a control, Project Safe Guard (PSG), which is a counseling intervention that does not focus on the potential influence of PTSD symptoms on firearm storage practices. This will help to determine if PSG-T works better than PSG to increase secure firearm storage in adults with elevated PTSD symptoms.

Participants will:

  • Complete a baseline survey
  • Receive the counseling intervention
  • Complete a survey immediately after the intervention and at 1-, 3-, and 6-months following the intervention

Conditions

PTSD

Firearm Injury

Suicide Prevention

Firearm Safety

Study ID

NCT06876740

Start date

May 15, 2025

Status verified date

May, 2025

Completion date

Sep 14, 2028

Anticipated

Primary completion date

Jun 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 18+ years
  • Firearm owner
  • History of one or more victimization traumas per the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (LEC-5), defined as having directly experienced physical assault, sexual assault, combat, and/or captivity
  • Positive posttraumatic stress disorder (PTSD) screen on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
  • Willing to provide physical location at time of Zoom sessions
  • Willing to keep Zoom camera on during study sessions
  • Ability to read, write, and speak English

Exclusion Criteria:

  • Currently stores all personal firearms unloaded and locked
  • Active psychosis or acute mania necessitating clinical intervention
  • Acute thoughts of self- or other-harm necessitating imminent clinical intervention (e.g., hospitalization)
  • Unable to provide informed consent

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Project Safe Guard - Trauma

Participants randomized into this arm will be offered Project Safe Guard-Trauma (PSG-T), which is a brief, single-session intervention designed to promote secure firearm storage practices among individuals with PTSD. Participants in this arm will also receive crisis response planning (CRP).

active comparator: Project Safe Guard

Participants randomized into this arm will be offered Project Safe Guard (PSG), which is a brief, single-session intervention designed to promote secure firearm storage practices. Participants in this arm will also receive crisis response planning (CRP).

Interventions

Project Safe Guard - Trauma

Project Safe Guard-Trauma (PSG-T) is a brief (15- to 20-minute), single-session lethal means safety counseling intervention (LMSC) for firearm-owning individuals with posttraumatic stress disorder (PTSD). PSG-T is designed to promote secure firearm storage practices by (1) using motivational interviewing techniques and (2) addressing the functional link between PTSD symptoms and unsafe firearm storage practices. In motivational interviewing-based LMSC, the clinician uses a guided approach to help individuals identify their values and motivations for secure firearm storage, rather than prescribing a certain set of actions. The focus is on respecting patients' autonomy and normalizing responsible firearm ownership by developing discrepancies, amplifying ambivalence, expressing empathy, rolling with resistance, and supporting self-efficacy. PSG-T combines PSG-proven motivational interviewing techniques with PTSD- and firearm-specific psychoeducation.

Project Safe Guard

Project Safe Guard-Trauma (PSG) is a brief (15- to 20-minute), single-session lethal means safety counseling intervention (LMSC) for firearm-owning individuals. PSG-T is designed to promote secure firearm storage practices by using motivational interviewing techniques. In motivational interviewing-based LMSC, the clinician uses a guided approach to help individuals identify their values and motivations for secure firearm storage, rather than prescribing a certain set of actions. The focus is on respecting patients' autonomy and normalizing responsible firearm ownership by developing discrepancies, amplifying ambivalence, expressing empathy, rolling with resistance, and supporting self-efficacy.

Primary outcome measure

  • Firearm Storage Practices [ Time Frame: Baseline to 6-Month Follow-Up ]

Central Contacts and Locations

Central contacts

Ian Stanley, PhD

720-848-6777ian.stanley@cuanschutz.edu

Julia Finn, MPH

(303) 653-6000emed_stanleylab@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Julia Finn, MPH

303-653-6000emed_stanleylab@cuanschtuz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 20, 2025

Last verified

May, 2025

Keywords

  • PTSD
  • Firearm Injury
  • Suicide Prevention
  • Firearm safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-05-20.