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

Trial Summary

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 data supports the effectiveness of the treatment Project Safe Guard-Trauma for PTSD?

Research on similar cognitive-behavioral programs, like the Trauma Recovery Group, shows that participants who completed the program had significant improvements in PTSD symptoms and depression. This suggests that structured, therapeutic interventions can be effective in managing PTSD. ^{1 2 3 4 5}

How is Project Safe Guard-Trauma treatment different from other PTSD treatments?

Project Safe Guard-Trauma is unique because it may incorporate elements from cognitive-behavioral therapy (CBT), which focuses on changing negative thought patterns and behaviors, and could be designed for specific populations or settings, such as those with severe mental illness or in community mental health centers. This approach might include components like breathing retraining and cognitive restructuring, which are not always emphasized in other PTSD treatments. ^{1 2 6 7 8}

What is the purpose of this trial?

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Trauma Recovery Group: a cognitive-behavioral program for post-traumatic stress disorder in persons with severe mental illness. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Internet-based early intervention to prevent posttraumatic stress disorder in injury patients: randomized controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The effectiveness of a group intervention to facilitate posttraumatic growth among women with breast cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Enhancing patient satisfaction and increasing treatment compliance: patient education as a fundamental component of PTSD treatment. [2019]

5. Switzerland 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Using a Veterans Affairs Posttraumatic Stress Disorder Group Therapy Program With Refugees. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The Primary Prevention of PTSD in Firefighters: Preliminary Results of an RCT with 12-Month Follow-Up. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The Psychopharmacology Algorithm Project at the Harvard South Shore Program: an update on posttraumatic stress disorder. [2022]