Project Safe Guard-Trauma for PTSD

(PSG-T Trial)

Overseen By Ian Stanley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Active psychosis, Acute mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a counseling program called Project Safe Guard-Trauma can help adults with PTSD (posttraumatic stress disorder) store firearms more securely. The study compares two counseling approaches to identify which one better encourages safe storage and raises awareness of its relation to suicide risk. It suits firearm owners with PTSD who have experienced specific traumas, such as physical or sexual assault. Participants will complete surveys and attend a single counseling session via Zoom. As an unphased trial, this study provides participants the chance to contribute to important research that could improve PTSD care and firearm safety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on counseling for firearm storage practices, so it's unlikely that medication changes are required.

What prior data suggests that Project Safe Guard-Trauma is safe for participants?

Research has shown that Project Safe Guard-Trauma (PSG-T) helps individuals with PTSD store firearms more safely through a counseling approach. This method has been tested in studies of similar programs.

PSG-T involves only counseling sessions, with no medications or physical treatments, eliminating concerns about drug side effects. Participants receive guidance on firearm safety and crisis planning, aiming to reduce risks associated with unsafe firearm storage.

As PSG-T focuses on counseling, there is no risk of physical harm from the treatment itself. Participants can feel at ease knowing the program centers on education and support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Project Safe Guard-Trauma treatment because it offers a fresh approach to managing PTSD by focusing on secure firearm storage practices. Unlike traditional PTSD treatments like cognitive-behavioral therapy or medication, this intervention is a brief, single-session strategy aimed at reducing potential harm by promoting safer environments. Additionally, it incorporates crisis response planning, providing participants with actionable steps to handle crises effectively. This innovative method addresses a critical safety concern for individuals with PTSD in a practical and immediate way.

What evidence suggests that Project Safe Guard-Trauma is effective for increasing secure firearm storage in adults with PTSD?

Research has shown that Project Safe Guard (PSG), a program in this trial, successfully encourages military service members to use gun locks. Participants in this trial may be randomized to receive Project Safe Guard-Trauma (PSG-T), a version specifically designed for individuals with PTSD (posttraumatic stress disorder). Its goal is to promote safer gun storage. Early results suggest that focusing on PTSD symptoms can improve secure gun storage habits. By addressing the specific needs of those with PTSD, PSG-T aims to enhance safety and lower the risk of suicide linked to unsafe gun storage. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who own firearms and have experienced traumas like assault or combat, leading to positive PTSD screening. They must be able to participate in Zoom sessions with their camera on and provide their location during these sessions. Participants should also be fluent in English.

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)

Exclusion Criteria

I am unable to understand and agree to the study details on my own.

Currently stores all personal firearms unloaded and locked

Active psychosis or acute mania necessitating clinical intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline survey to assess initial knowledge and behaviors regarding firearm storage and PTSD symptoms

1 day

1 visit (in-person or virtual)

Intervention

Participants receive a single-session LMSC intervention, either PSG-T or PSG, designed to promote secure firearm storage practices

1 day

1 visit (in-person or virtual)

Follow-up

Participants complete follow-up assessments to evaluate changes in knowledge, intentions, and behaviors regarding firearm storage at 1-, 3-, and 6-month intervals

6 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Project Safe Guard
• Project Safe Guard-Trauma

Trial Overview The study tests if Project Safe Guard-Trauma (PSG-T), a counseling program, can improve secure firearm storage among those with PTSD symptoms. It will be compared to the standard Project Safe Guard (PSG) to see if adding a focus on PTSD makes a difference.

How Is the Trial Designed?

Group I: Project Safe Guard - Trauma Experimental Treatment 1 Intervention

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).

Group II: Project Safe Guard Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

The PTSD Recovery Program, which includes group therapy alongside individual therapy and medication, was effectively used to treat PTSD in 18 refugees over 10 weekly sessions, showing positive outcomes based on pre- and post-intervention questionnaires.

Qualitative data from participants indicated symptom improvement, and providers reported high satisfaction with the program, supporting its efficacy as an adjunctive treatment for PTSD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Veterans Affairs Posttraumatic Stress Disorder Group Therapy Program With Refugees. Haefner, J., Abedi, M., Morgan, S., et al.[2019]

A randomized clinical trial involving 135 patients will compare the online efficacy of trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP), and positive psychotherapy (PPT) in reducing PTSD symptoms during the COVID-19 pandemic.

The study aims to show that all three therapies can effectively reduce PTSD symptoms, anxiety, and depression, with no significant differences expected among them, highlighting the potential for flexible online treatment options for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial to Assess the Efficacy of Online-Treatment with Trial-Based Cognitive Therapy, Mindfulness-Based Health Promotion and Positive Psychotherapy for Post-Traumatic Stress Disorder during the COVID-19 Pandemic: A Study Protocol. Duran, ÉP., Hemanny, C., Vieira, R., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06876740/project-safe-guard-trauma?state=CO&city=13123%20East%2016th%20Avenue,%20Aurora

Project Safe Guard-Trauma | Clinical Research Trial Listing The goal of this randomized controlled trial is to determine if a counseling intervention, Project Safe Guard-Trauma (PSG-T), increases secure firearm ...

2. adaa.trialstoday.org adaa.trialstoday.org/trial/NCT06876740

Project Safe Guard-Trauma ... Safe Guard-Trauma (PSG-T), increases secure firearm storage practices in adults who screen positive for posttraumatic stress disorder (PTSD).

3. trial.medpath.com trial.medpath.com/clinical-trial/87a09e483f0efea4/nct06876740-project-safe-guard-trauma-counseling

Project Safe Guard-Trauma | MedPath 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12490531/

Project Safe Guard–Trauma (PSG-T) One LMSC intervention, Project Safe Guard (PSG), has demonstrated efficacy in prompting use of firearm locking devices in a sample of military service members; ...

5. trialx.com trialx.com/clinical-trials/listings/298430/project-safe-guard-trauma/

Project Safe Guard-Trauma | Clinical Research Trial Listing ... ... Safe Guard-Trauma (PSG-T), increases secure firearm storage practices in adults who screen positive for posttraumatic stress disorder (PTSD).

6. researchgate.net researchgate.net/publication/396069456_Project_Safe_Guard-Trauma_PSG-T_Protocol_for_a_randomized_controlled_trial_of_lethal_means_safety_counseling_to_promote_secure_firearm_storage_among_individuals_with_PTSD

Project Safe Guard–Trauma (PSG-T) Project Safe Guard–Trauma (PSG-T): Protocol for a randomized controlled trial of lethal means safety counseling to promote secure firearm ...

7. academic.oup.com academic.oup.com/milmed/article/189/Supplement_3/510/7735924

Project Safe Guard: Evaluating a Lethal Means Safety ... Specifically, outcomes assessed included personal knowledge, attitudes, and behaviors related to firearm suicide and secure firearm storage, ...