Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
168 participants
INTERVENTIONAL
2025-05-15
2028-09-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD
NCT06723834
Online Psychoeducation for the Prevention of PTSD
NCT03496714
Evaluating The Efficacy Of Combined Cognitive Processing Therapy and Stellate Ganglion Blocks for PTSD
NCT06570213
Examining Effects of a Therapeutic Focus on Positive Memories on Post-Trauma Health
NCT05523453
Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault
NCT00057629
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Project Safe Guard-Trauma (PSG-T) is a brief LMSC intervention rooted in PSG principles but adapted specifically for firearm-owning individuals with PTSD. This study will evaluate the efficacy of PSG-T compared with control (standard PSG) in prompting more secure firearm storage behaviors. This study is a 2-arm randomized controlled trial. Participants will be randomized following the pre-intervention assessment. The participants will receive a single-session LMSC intervention, post-intervention assessment, and 1-, 3-, and 6- month follow-up assessments. The goal is to increase knowledge about the link between firearm storage practices and suicide risk, intentions to store firearms safely, and actual safer firearm storage behaviors.
Aim 1: To conduct a 2-armed randomized control trial to evaluate the efficacy of PSG-T compared with a control (PSG) in increasing knowledge about the link between firearm storage practices and suicide risk, intentions to store firearms safely, and actual safer firearm storage behaviors.
Hypothesis 1: Compared with PSG, at 1-, 3-, and 6-month follow-up, PSG-T will result in greater (a) knowledge about the link between firearm storage practices and suicide risk, (b) intentions to store firearms securely, and (c) actual more secure firearm storage behaviors (primary outcome at 6-month follow-up).
Aim 2: To evaluate differences in PTSD-related negative cognitions about the world as a potential mechanism of change in PSG-T for increasing knowledge, intentions, and behaviors regarding safe firearm storage practices.
Hypothesis 2: Participants who receive PSG-T will report fewer PTSD-related negative cognitions about the world compared with participants who receive PSG, and these decreases will be associated with increases in (a) knowledge about the link between firearm storage practices and suicide risk, (b) intentions to store firearms securely, and (c) actual more secure firearm storage behaviors.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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
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).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Colorado, Denver
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
University of Colorado Anschutz Medical Campus Department of Emergency Medicine Funded Research
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HT9425-24-1-0693
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24-1287
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.