PTSDPSG-TNCT06876740
Project Safe Guard-Trauma
A study testing Project Safe Guard - Trauma and Project Safe Guard in people with PTSD and Firearm Injury, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Firearm Injury, Suicide Prevention
- What is being tested?
- Project Safe Guard - Trauma and Project Safe Guard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 14 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Julia Finn, MPH, 303-653-6000, emed_stanleylab@cuanschtuz.edu
About this study
Official title: Project Safe Guard-Trauma (PSG-T): A Randomized Controlled Trial of Counseling to Promote a Secure Home Environment
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?
Read more
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
Read the detailed description
Firearms are the most common suicide method among service members, veterans, and civilians. Secure firearm storage reduces the risk of suicide. Lethal means safety counseling (LMSC) is an effective approach to promote secure firearm storage and, therefore, decrease the risk of suicide. Suicide risk is elevated among individuals with posttraumatic stress disorder (PTSD). PTSD affects safety perceptions and firearm storage practices. Current data indicate that the gold standard existing LMSC intervention - Project Safe Guard (PSG) - has reduced efficacy for individuals with elevated PTSD symptoms. Thus, there is a need to adapt LMSC for individuals with elevated PTSD symptoms.
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
- PTSD, Firearm Injury, Suicide Prevention, Firearm Safety
- Being tested
- Project Safe Guard - Trauma, Project Safe Guard
- Keywords
- PTSD, Firearm Injury, Suicide Prevention, Firearm safety
- Medical subject headings
- Stress Disorders, Post-Traumatic, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project Safe Guard - TraumaBehavioural
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 GuardBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Project Safe Guard - Trauma | Experimental | 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). Receives: Behavioral: Project Safe Guard - Trauma |
| Project Safe Guard | Active comparator | 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). Receives: Behavioral: Project Safe Guard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Firearm Storage Practices
The primary endpoint is the improvement in actual secure firearm storage practices, as measured at the 6-month follow-up assessment, compared with baseline. The firearm storage assessment includes a grid question asking whether personally owned firearms are locked or unloaded-indicating secure storage practices. Participants can indicate that "none," "some," or "all" of their firearms are in an unloaded or locked condition.
We assign a score of 2 if the secure practice applies to all firearms, 1 if it applies to some firearms, and 0 if it applies to none. A higher score corresponds to more secure storage practices. The maximum score, achieved when all firearms are both unloaded and locked, is 4, while the minimum score is 0. Improvement will be defined as a change score > 0 between the pre-intervention and 6-month follow-up assessments.
Measured: Baseline to 6-Month Follow-Up
Secondary outcomes (7)
Knowledge of Firearm Storage Practices and Suicide Risk Link
Participants will be asked, "To what extent do you think owning a firearm is related to suicide risk?" and "To what extent do you think how a firearm is stored (e.g., unlocked, loaded) is related to suicide risk?" Responses are captured on a 5-point Likert scale (1 = Not at all, 2= Slightly, 3 = Moderately, 4 = Strongly, 5 = Extremely).
Measured: Baseline to 6-Month Follow-Up
Intentions to Securely Store Firearms
Participants will be asked: (a) "How likely would you be to adhere to your clinician's recommendations to store your firearm locked for safety purposes?" and (b) "How likely would you be to adhere to your clinician's recommendations to store your firearm unloaded for safety purposes?" Responses are captured on a 5-point scale (1 = Very Unlikely, 2 = Unlikely, 3 = Neutral/Possibly, 4 = Likely, 5 = Very Likely).
Measured: Baseline to 6-Month Follow-Up
Posttraumatic Cognitions Inventory (PTCI) negative-world subscale
Posttraumatic stress disorder-related negative cognitions about the world will be evaluated using the Posttraumatic Cognitions Inventory (PTCI). The PTCI is a 33-item self-report measure of negative cognitions about the self and world and self-blame. Respondents rate the degree to which they agree or disagree with each statement on a 7-point scale (1 = Totally disagree, 2 = Disagree very much, 3 = Disagree slightly, 4 = Neither agree nor disagree, 5 = Agree slightly, 6 = Agree very much, 7 = Totally agree). We will use the total score of the 7-item PTCI negative-world subscale to measure the purported mediator of change of Project Safe Guard-Trauma
Measured: Baseline to 6-Month Follow-Up
Client Satisfaction Questionnaire-8 (CSQ-8)
Participant acceptability of services will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8), an 8-item self-report measure. Each item evaluated using varying descriptive scales with corresponding numerical values. Scores are summed across items, with higher values indicating greater acceptability of the services received.
Measured: Baseline to 6-Month Follow-Up
Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Illness-5 (DSM-5) (PCL-5):
PTSD symptoms will be evaluated using the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure. Participants rate the severity of each symptom over the past month on a 5-point scale (0 =Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). A composite score is generated from responses with symptom cluster scores corresponding to DSM-5 diagnostic criteria (i.e., intrusions, avoidance, negative alterations in cognitions and mood, hyperarousal); higher scores reflect more severe PTSD symptomatology.
Measured: Baseline to 6-Month Follow-Up
Depressive Symptom Index-Suicidality Subscale (DSI-SS)
Suicidal ideation severity over the past 2 weeks will be evaluated using the Depressive Symptom Index-Suicidality Subscale (DSI-SS), a 4-item self-report measure. Respondents rate each item on a 4-point scale ranging from 0 to 3 (e.g., Item 1: 0 = I do not have thoughts of killing myself; 1 = Sometimes I have thoughts of killing myself; 2 = Most of the time I have thoughts of killing myself; 3 = I always have thoughts of killing myself). A total score ranging from 0 to 12 is calculated from summed responses, with higher scores indicating more severe suicidal ideation.
Measured: Baseline to 6-Month Follow-Up
Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
The self-report SITBI-R assesses various aspects of self-injurious thoughts and behaviors. The evaluation measures will only include the questions about the lifetime occurrence of the target construct (e.g., the suicidal ideation module asks respondents, "Have you ever had thoughts of killing yourself?").
Measured: Baseline to 6-Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start15 May 2025
- Primary completion14 Jun 2028 (estimated)
- Study completion14 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who meet inclusion and exclusion criteria will be equally randomized between the two intervention conditions following the pre-intervention assessment. We will use computerized block randomization to allocate participants into either Project Safe Guard-Trauma or Project Safe Guard. Block randomization will vary by the number of participants in each block to ensure that the research staff cannot anticipate the next randomization, thereby reducing potential for bias. Biostatisticians will oversee randomization.
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876740
- Sponsor's protocol ID
- 24-1287
- Other IDs
- HT9425-24-1-0693
- Acronym
- PSG-T
- Status last verified
- May 2025
- First submitted
- 10 Mar 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This trial involves sensitive participant information, including information regarding suicidality, mental health, and firearm ownership and requires careful handling to prevent any negative impact on participants or their families.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Safe Guard-Trauma (PSG-T): A Randomized Controlled Trial of Counseling to Promote a Secure Home Environment
- ClinicalTrials.gov ID
- NCT06876740
- Acronym / sponsor ID
- PSG-T / 24-1287
- Conditions
- PTSD, Firearm Injury, Suicide Prevention, Firearm Safety
- Keywords
- PTSD, Firearm Injury, Suicide Prevention, Firearm safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 14 Jun 2028 (estimated)
- Study completion
- 14 Sep 2028 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Firearms are the most common suicide method among service members, veterans, and civilians. Secure firearm storage reduces the risk of suicide. Lethal means safety counseling (LMSC) is an effective approach to promote secure firearm storage and, therefore, decrease the risk of suicide. Suicide risk is elevated among individuals with posttraumatic stress disorder (PTSD). PTSD affects safety perceptions and firearm storage practices. Current data indicate that the gold standard existing LMSC intervention - Project Safe Guard (PSG) - has reduced efficacy for individuals with elevated PTSD symptoms. Thus, there is a need to adapt LMSC for individuals with elevated PTSD symptoms.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who meet inclusion and exclusion criteria will be equally randomized between the two intervention conditions following the pre-intervention assessment. We will use computerized block randomization to allocate participants into either Project Safe Guard-Trauma or Project Safe Guard. Block randomization will vary by the number of participants in each block to ensure that the research staff cannot anticipate the next randomization, thereby reducing potential for bias. Biostatisticians will oversee randomization.
| Arm | Type | Receives |
|---|---|---|
| Project Safe Guard - Trauma | Experimental | Behavioral: Project Safe Guard - TraumaParticipants 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 | Active comparator | Behavioral: Project Safe GuardParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project Safe Guard - TraumaProject 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. | Behavioural | Project Safe Guard - Trauma |
| Project Safe GuardProject 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. | Behavioural | Project Safe Guard |
Primary outcome
Firearm Storage Practices
Time frame: Baseline to 6-Month Follow-Up
The primary endpoint is the improvement in actual secure firearm storage practices, as measured at the 6-month follow-up assessment, compared with baseline. The firearm storage assessment includes a grid question asking whether personally owned firearms are locked or unloaded-indicating secure storage practices. Participants can indicate that "none," "some," or "all" of their firearms are in an unloaded or locked condition. We assign a score of 2 if the secure practice applies to all firearms, 1 if it applies to some firearms, and 0 if it applies to none. A higher score corresponds to more secure storage practices. The maximum score, achieved when all firearms are both unloaded and locked, is 4, while the minimum score is 0. Improvement will be defined as a change score > 0 between the pre-intervention and 6-month follow-up assessments.
7 secondary outcomes
Knowledge of Firearm Storage Practices and Suicide Risk Link
Time frame: Baseline to 6-Month Follow-Up
Intentions to Securely Store Firearms
Time frame: Baseline to 6-Month Follow-Up
Posttraumatic Cognitions Inventory (PTCI) negative-world subscale
Time frame: Baseline to 6-Month Follow-Up
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Baseline to 6-Month Follow-Up
Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Illness-5 (DSM-5) (PCL-5):
Time frame: Baseline to 6-Month Follow-Up
Depressive Symptom Index-Suicidality Subscale (DSI-SS)
Time frame: Baseline to 6-Month Follow-Up
Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
Time frame: Baseline to 6-Month Follow-Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- University of Colorado Anschutz Medical Campus Department of Emergency Medicine Funded ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No. This trial involves sensitive participant information, including information regarding suicidality, mental health, and firearm ownership and requires careful handling to prevent any negative impact on participants or their families.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Safe Guard - Trauma and Project Safe Guard in people with PTSD and Firearm Injury, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian Stanley, PhD (720-848-6777, ian.stanley@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Firearm Storage Practices (time frame: Baseline to 6-Month Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.