Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT05818696

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Lethal Means Counseling (LMC)

CBT for Uncertainty - Enhanced (CUE)

Study Details

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

Study ID

NCT05818696

Start date

Jun 26, 2023

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: LMC - CUE

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

experimental: CUE - LMC

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

Interventions

Lethal Means Counseling (LMC)

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)

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.

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) ]

Central Contacts and Locations

Central contacts

Nicholas Allan, PhD

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

Sarah Irvin, MS

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

Locations

Ohio State University Department of Psychiatry and Behavioral Health

Recruiting

Columbus, Ohio, United States, 43062

More Information

Sponsor

Ohio State University

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-02-24.