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AnxietyUFOSNCT05818696

Uncertainty and Firearms: Obtaining Secure Storage

A study testing Lethal Means Counseling (LMC) and CBT for Uncertainty - Enhanced (CUE) in people with Anxiety, run by Ohio State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to test whether inclusion of cognitive behavioral therapy (CBT) for Uncertainty-Enhanced (CUE) with Lethal Means Counseling (LMC) is acceptable, feasible, and efficacious in addressing secure firearm storage and associated psychological constructs in active duty servicemembers. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety
What is being tested?
Lethal Means Counseling (LMC) and CBT for Uncertainty - Enhanced (CUE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
26 Jun 2023to 1 Mar 2027
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • are currently serving in any Branch or Component of the U.S. military, or were discharged from the U.S. military within the past 90 days
  • 18 years or older
  • Intolerance of uncertainty scale-12 total score equal to or greater than 35 (i.e., one SD above the community mean)
  • own at least one firearm located in their home or vehicle that is stored unlocked and loaded (i.e., not secure storage)
  • are able to speak and understand the English language

Who cannot join

  • do not pass the Informed Decision Making Capacity (IDMC) screener, suggesting severe cognitive impairment
  • have a psychiatric or medical condition that would prevent them from providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication)
  • no or limited access to an Android or Apple smartphone that is compatible with the EMA application

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ohio State University Department of Psychiatry and Behavioral Health

    Columbus, Ohio, 43062

Other trials in United States

About this study

Official title: A Brief Fear of Uncertainty-Focused Intervention as an Adjunct to Lethal Means Counseling

The goal of this clinical trial is to test whether inclusion of cognitive behavioral therapy (CBT) for Uncertainty-Enhanced (CUE) with Lethal Means Counseling (LMC) is acceptable, feasible, and efficacious in addressing secure firearm storage and associated psychological constructs in active duty servicemembers. The clinical trial aims to:

  • Assess the preliminary efficacy of a LMC intervention, augmented with CUE, on firearm storage practices
  • Examine mechanisms through which CUE and LMC increase firearm storage practices
  • Assess credibility and acceptability of LMC
Read more

Participants will complete:

  • One baseline visit
  • Two intervention sessions-CUE and LMC
  • Six brief surveys per day for 28 days using a mobile application
  • One mid-point survey and five follow-up surveys
Read the detailed description

Firearms are the leading cause of death in US suicides and account for more than 60% of military suicides. A primary driver of these high rates appears to be ready access to firearms. Research suggests that firearm suicides could potentially be reduced by reducing and/or limiting access to firearms. Considering these data, lethal means counseling (LMC) is a recommended best practice for suicide prevention (e.g., National Action Alliance for Suicide Prevention). Results of a recently completed Department of Defense-sponsored randomized control trial (RCT) conducted by the investigators showed that safe firearm storage practices (i.e., use of locking devices and/or safes) could be increased among Servicemembers using a brief lethal means counseling (LMC) protocol developed in part by the investigators. Though superior to control, 45% of Servicemembers who received LMC still maintained at least one unsafely stored firearm, suggesting they continued to experience barriers to behavior change. Accumulating evidence suggests that fear of the unknown-a form of anxiety commonly experienced by people with low tolerance for uncertainty-may be an important barrier to safe firearm storage. The primary aim of Project 5 is to test a brief modular intervention to improve the effectiveness of LMC on safe firearm storage practices among firearm-owning Servicemembers. In this study, the investigators will examine if LMC's effects on firearm storage practices can be enhanced among Servicemembers who first receive an intervention designed to reduce their intolerance of uncertainty (IU). These results could provide important information about how LMC can be most effectively delivered to an especially high risk subgroup of firearm-owning Servicemembers.

F1.1. Firearm Acquisition and Storage as a Strategy to Cope with Fear of the Unknown. The coping model of protective gun ownership posits that people acquire firearms to reduce distress experienced from inflated perceptions of environmental threat, and are unlikely to safely store firearms because doing so is perceived to inhibit readiness to respond to unexpected and uncertain threats. Firearm owners who acquire firearms for the primary purpose of self-protection (i.e., protective firearm owners) report overgeneralized perceptions of the world and other people as dangerous and/or threatening. Among firearm owners, exaggerated threat perceptions are also associated with the intention to acquire additional firearms. Negative affect is significantly higher among firearm owners who use no safe storage practices (F(1,872)=6.9, p=.009). Anxiety about the unknown may therefore serve as a barrier to safe firearm storage and decrease the effectiveness of LMC. The investigators will test this hypothesis by testing the impact of a brief intervention designed to reduce IU when delivered to firearm-owning Servicemembers.

F1.2. Intolerance of Uncertainty as a Risk Factor for Anxiety and Unsafe Firearm Storage. IU involves an aversion to ambiguity and increased distress when experiencing uncertainty. Elevated IU amplifies the experience of stress and anxiety, causing people to engage in maladaptive cognitive and behavioral strategies to reduce distress. It is posited that IU may impact a Servicemember's perception of threat from the environment and that this heightened threat perception will limit their desire for safe storage practices. This is supported by a recent study by the investigators in which IU and exaggerated threat expectancy were significantly higher among adults intending to acquire a firearm as compared to those who were not (partial η2=.014-.017). Among Servicemembers with elevated IU, adoption of safe firearm storage practices may therefore be enhanced if IU is first reduced. This hypothesis will be tested in the current study using an empirically-supported, brief web-based intervention. The use of a web-based intervention platform significantly improves the potential scale and reach of the intervention.

F1.3. Targeting IU to Enhance Lethal Means Counseling (LMC). IU is an ideal construct to target in a web-based intervention given the abundance of research finding elevations in IU across a broad spectrum of suicide risk factors. For example, IU is a strong transdiagnostic correlate of many psychological and behavioral disorders associated with increased risk for suicide: generalized anxiety disorder, major depression, obsessive compulsive disorder, social anxiety disorder, panic disorder and agoraphobia, substance use disorders, eating disorders, and posttraumatic stress disorder. Other studies have implicated IU as a risk factor for suicidal thoughts and behaviors. IU is malleable, even in very brief interventions. In a recent study, the investigators conducted the only RCT of a CBT-based intervention for IU. In that study, an in-person IU Treatment (IUT) comprised of psychoeducation and cognitive reappraisal techniques was compared to a control condition focused on psychoeducation about health lifestyle behaviors. IUT led to significantly larger reductions in IU, anxiety, and depression during follow-up, indicating IU can be reduced with a brief intervention. Results of that study also showed that the majority of participants found the intervention easy to understand, helpful, and applicable to their daily lives.

F1.4. IUT Refinement. Since completing this first RCT, this intervention has been refined to improve the intervention. When modifying interventions, it is critical to involve relevant stakeholders in the process. Two key alterations to IUT include a web-based delivery and augmenting IUT with a mobile app for ecological momentary assessment (EMA) and ecological momentary intervention (EMI). EMI is ideal for these brief interventions because it allows for participants to gain much-needed practice of challenging negative automatic thoughts and completing behavioral experiments in real-time, thereby improving internalization of learned skills and strategies. The investigators recently completed a focus group with 8 people (M age = 33.13, standard deviation [SD] = 11.50; 62.5% female) reporting IU at least 1 SD above the community mean (M = 43.75, SD = 7.5). Participants reported the content was accessible, easily understood, and highly relevant to their distress. Participants thought inclusion of EMA and EMI would improve participant engagement and reported they would not perceive completion of multiple surveys daily to be a burden. Participants also believed that personalized content would increase engagement. Finally, participants assisted in identifying exemplar behavioral experiments and in refining a delivery mechanism as successful completion of behavioral experiments is a core driver in anxiety-based CBT interventions. Similar augmentations to brief interventions for stress (d = .5), generalized anxiety disorder (ds = .4-.6), and panic disorder (d = .5) have been successful in enhancing intervention effects, further underscoring the promise of including EMI to optimize outcomes.

F1.5. Summary. In a recently completed RCT, the investigators showed that LMC increases firearm storage practices among firearm-owning Servicemembers. Despite these promising results, nearly half of Servicemembers did not fully adopt safe firearm storage practices. Subsequent research suggests that exaggerated perceptions of the world as a dangerous and threatening place may be a barrier to these practices. This study is designed to determine if a brief intervention that has been shown to reduce IU-a cognitive bias that increases threat perceptions and anxiety-can increase the effectiveness of LMC. This project will be the first to test a brief modular intervention to improve LMC as a preventative intervention for suicide. These results could inform community-based suicide prevention efforts in the DoD and may also improve the effectiveness of LMC delivered within healthcare settings.

Conditions
Anxiety
Being tested
Lethal Means Counseling (LMC), CBT for Uncertainty - Enhanced (CUE)
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lethal Means Counseling (LMC)Behavioural

    The research interventionist uses a guiding approach to identify methods for secure firearm storage and reflects the participant's reasons for and against secure firearm storage, with a particular focus on the service member's verbalized reasons for wanting to adopt or use the identified storage methods.

  • CBT for Uncertainty - Enhanced (CUE)Behavioural

    CUE consists of a 1-hour manualized intervention that uses interactive content to enhance participant learning of critical intervention components. The session includes (1) psychoeducation regarding the role of IU in exacerbating anxiety/mood sensations, (2) practice identifying and challenging maladaptive thoughts about uncertainty and accompanying distress, and (3) behavioral activities to challenge participants' capacity to handle uncertainty.

Study groups in NCT05818696
Study groupRoleWhat they receive
LMC - CUEExperimentalIn this arm, participants will receive Lethal Means Counseling before receiving CBT for Uncertainty-Enhanced (CUE).
Receives: Behavioral: Lethal Means Counseling (LMC); Behavioral: CBT for Uncertainty - Enhanced (CUE)
CUE - LMCExperimentalIn this arm, participants will receive CBT for Uncertainty-Enhanced (CUE) before receiving Lethal Means Counseling.
Receives: Behavioral: Lethal Means Counseling (LMC); Behavioral: CBT for Uncertainty - Enhanced (CUE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Researcher developed items capturing changes in firearm storage practices

    Firearm storage practices are assessed by asking participants: How often are the following specific firearm storage practices used (1) stored using a locking device, (2) stored in a locked location (e.g., lockbox, gun safe), (3) stored loaded. Questions are rated from never (0%) to always (100%) with higher scores indicating greater percentage using particular firearm storage practices.

    Measured: Change will be assessed from baseline to a) two weeks after the first intervention (midpoint) (b) two weeks after the second intervention (postintervention) and (c) six months after the first intervention (6 month followup)

Secondary outcomes (6)
  1. Credibility/Expectancy Questionnaire

    Satisfaction with the interventions is measured using the Credibility/Expectancy Questionnaire (CEQ). The CEQ measures credibility and expectancy with a 6-item measure. Each item is measured on a 9-point scale from 1 to 9 with higher scores indicating a more positive rating. Scores range from 6 to 54.

    Measured: Four weeks after the first intervention session (postintervention)

  2. Patient Satisfaction Questionnaire

    Satisfaction with the interventions is measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ measures patient satisfaction using an 11-item measure. Each item is measured on a 5-point scale from (1) Strongly Disagree to (5) Strongly Agree. Higher scores indicate greater satisfaction with the intervention components with scores ranging from 11 to 55.

    Measured: Four weeks after the first intervention session (postintervention)

  3. Change in Intolerance of Uncertainty-12 scale score

    Intolerance of uncertainty is measured using the 12-item Intolerance of Uncertainty Scale - Short Form. Each item is measured on a 5-point scale from (1) Not At All Characteristic Of Me to (5) Entirely Characteristic Of Me. Higher scores indicate worse intolerance of uncertainty with scores ranging from 12 to 60.

    Measured: Change will be assessed from baseline to a) two weeks after the first intervention (midpoint) and two weeks after the second intervention (postintervention)

  4. Change in Intolerance of Uncertainty - Implicit Bias

    Intolerance of uncertainty is measured using an Implicit Association Test (IAT-Intolerance of Uncertainty). The test includes 20 items across four stimuli categories. Implicit association test (IAT) scores were calculated according to the algorithm developed by Greenwald, Nosek, and Banaji (2003) to combine accuracy and RT (across practice and test trials) into a single value. Using this algorithm IAT-IU scores of zero indicate no bias, positive scores indicate a bias toward pairing self-words with IU-words, and negative scores indicate a bias toward pairing self-words with certain-words.

    Measured: Change will be assessed from baseline to a) two weeks after the first intervention (midpoint) and two weeks after the second intervention (postintervention)

  5. Change in Firearm Implicit Bias

    Bias towards firearms is measured using an Implicit Association Test (IAT-Firearms). The test includes 20 items across four stimuli categories. IAT scores were calculated according to the algorithm developed by Greenwald, Nosek, and Banaji (2003) to combine accuracy and RT (across practice and test trials) into a single value. Using this algorithm IAT scores of zero indicate no bias, positive scores indicate a positive bias regarding firearm storage practices, and negative scores indicate a negative bias regarding firearm storage practices.

    Measured: Change will be assessed from baseline to a) two weeks after the first intervention (midpoint) and two weeks after the second intervention (postintervention)

  6. Researcher developed questions assessing change in openness to utilize firearm storage practices

    Openness to utilize firearm storage practices are assessed by asking participants: How open are you to engage in the following specific firearm storage practices (1) store using a locking device, (2) store in a locked location, (3) store unloaded. Questions are rated from not at all (1) to extremely open (5). Participants may also respond 'I already store all of my firearms in this manner.' Higher scores indicate a greater willingness to utilize certain firearm storage practices.

    Measured: Change will be assessed from baseline to a) two weeks after the first intervention (midpoint) (b) two weeks after the second intervention (postintervention) and (c) six months after the first intervention (6 month followup)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study start26 Jun 2023
  3. Primary completion25 Aug 2026
  4. Study completion1 Mar 2027 (estimated)

Resources

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
Crossover
Model description
All participants receive both interventions but the order in which a participant receives the interventions is randomized.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05818696
Sponsor's protocol ID
PR210299
Acronym
UFOS
Status last verified
Apr 2026
First submitted
2 Mar 2023
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All de-identified demographic and clinical data collected as part of this project will be available as raw individual-level data for sharing with external researchers working at an institution with a Federalwide Assurance (FWA) for the Protection of Human Subjects. Data will therefore be available for secondary analytic purposes. Names and institutions of persons either given or denied access to data will be tracked by our Administrative Core and will be available upon request from the sponsor. Data will not be available for data sharing until after this project is complete and the primary outcomes are published.

Questions about this trial

What is this clinical trial studying?

A study testing Lethal Means Counseling (LMC) and CBT for Uncertainty - Enhanced (CUE) in people with Anxiety, run by Ohio State University 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Researcher developed items capturing changes in firearm storage practices (time frame: Change will be assessed from baseline to a) two weeks after the first intervention (midpoint) (b) two weeks after the second intervention (postintervention) and (c) six months after the first intervention (6 month followup)). 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 22 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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