Uncertainty and Firearms: Obtaining Secure Storage

NCT05818696 | Recruiting

• 1 other identifier: PR210299
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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 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

Conditions

Anxiety

Outcome Measures

Primary Outcomes (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.

  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)

• Credibility/Expectancy Questionnaire

  Four weeks after the first intervention session (postintervention)

• Patient Satisfaction Questionnaire

  Four weeks after the first intervention session (postintervention)

• Change in Intolerance of Uncertainty-12 scale score

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

• Change in Intolerance of Uncertainty - Implicit Bias

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

• Change in Firearm Implicit Bias

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

Other Outcomes (1)

• Researcher developed questions assessing Firearm Acquisition

  four weeks after the intervention and 3, 6, 9, and 12-month follow-up

Study Arms (2)

LMC - CUE

EXPERIMENTAL

In this arm, participants will receive Lethal Means Counseling before receiving CBT for Uncertainty-Enhanced (CUE).

Behavioral: Lethal Means Counseling (LMC); Behavioral: CBT for Uncertainty - Enhanced (CUE)

CUE - LMC

EXPERIMENTAL

In this arm, participants will receive CBT for Uncertainty-Enhanced (CUE) before receiving Lethal Means Counseling.

Behavioral: Lethal Means Counseling (LMC); Behavioral: CBT for Uncertainty - Enhanced (CUE)

Interventions

Lethal Means Counseling (LMC) BEHAVIORAL

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.

CUE - LMC; LMC - CUE

CBT for Uncertainty - Enhanced (CUE) BEHAVIORAL

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.

CUE - LMC; LMC - CUE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers University: collaborator
• Ohio State University: lead

Study Sites (1)

Ohio State University Department of Psychiatry and Behavioral Health

Columbus, Ohio, 43062, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Nicholas Allan, PhD

CONTACT

614-814-1299; nicholas.allan@osumc.edu

Sarah Irvin, MS

CONTACT

614-814-1318; sarah.irvin@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters completing the outcome assessments will be blind to condition.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: All participants receive both interventions but the order in which a participant receives the interventions is randomized.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 19, 2023
• Study Start: June 26, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for at least the next two years. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)