Cognitive Behavioral Therapy for Anxiety Prevention in Servicemembers

(UFOS Trial)

Overseen By Sarah Irvin, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Severe cognitive impairment, Psychosis, Mania, others

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

Compensation: Varies

Number of Visits: 8

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that Cognitive Behavioral Therapy for Anxiety Prevention in Servicemembers is an effective treatment?

The available research does not provide specific data on the effectiveness of Cognitive Behavioral Therapy for Anxiety Prevention in Servicemembers. Instead, it focuses on a different therapy called Managing Cancer and Living Meaningfully (CALM), which is used for patients with advanced cancer. This therapy has shown promising results in reducing distress and improving communication about mortality-related concerns in cancer patients. However, there is no direct information on the effectiveness of the therapy for anxiety prevention in servicemembers. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Anxiety Prevention in Servicemembers safe?

Lethal means safety counseling, a related intervention, has been studied in military settings and is generally considered safe. It involves counseling to reduce access to dangerous items like firearms and has shown positive outcomes in promoting safe storage practices without reported safety concerns. ^{6 7 8 9 10}

How does the treatment Cognitive Behavioral Therapy for Uncertainty-Enhanced (CUE) and Lethal Means Counseling (LMC) differ from other treatments for anxiety prevention in servicemembers?

Cognitive Behavioral Therapy for Uncertainty-Enhanced (CUE) and Lethal Means Counseling (LMC) is unique because it combines cognitive behavioral techniques specifically tailored to address uncertainty and anxiety with counseling focused on reducing access to lethal means, which is particularly relevant for servicemembers. This dual approach aims to prevent anxiety and enhance safety, setting it apart from standard anxiety treatments that may not address these specific concerns. ^{2 11 12 13 14}

Eligibility Criteria

This trial is for U.S. military members or recent veterans (discharged within the past 90 days), aged 18 or older, who score high on an uncertainty intolerance scale and own at least one unlocked and loaded firearm in their home or vehicle. Participants must speak English.

Inclusion Criteria

Individuals who are able to speak and understand the English language

Individuals who 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

Individuals who own at least one firearm located in their home or vehicle that is stored unlocked and loaded

Exclusion Criteria

Individuals with 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)

I have passed a test showing I can make informed health decisions.

Individuals with no or limited access to an Android or Apple smartphone that is compatible with the EMA application

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete one baseline visit to assess initial conditions and eligibility

1 day

1 visit (in-person)

Intervention

Participants receive two intervention sessions: CBT for Uncertainty-Enhanced (CUE) and Lethal Means Counseling (LMC)

4 weeks

2 visits (in-person)

Daily Surveys

Participants complete six brief surveys per day for 28 days using a mobile application

4 weeks

Follow-up

Participants are monitored for changes in firearm storage practices and psychological constructs

6 months

5 follow-up surveys

Treatment Details

Interventions

• CBT for Uncertainty - Enhanced (CUE)
• Lethal Means Counseling (LMC)

Trial Overview The study tests if adding Cognitive Behavioral Therapy for Uncertainty-Enhanced (CUE) to Lethal Means Counseling (LMC) helps active duty servicemembers store firearms more securely. It involves baseline visits, two therapy sessions, daily mobile surveys for a month, a mid-point survey, and follow-ups.

Participant Groups

Group I: LMC - CUE Experimental Treatment 2 Interventions

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

Group II: CUE - LMC Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Findings from Research

The CALM intervention, a brief psychotherapeutic approach for patients with advanced cancer, aims to reduce depression and end-of-life distress, with a focus on feasibility and preliminary efficacy in a single-arm trial involving adult patients with expected survival of at least 6 months.

The study will assess the effectiveness of CALM through participant completion rates and improvements in depressive symptoms, with a target of at least 70% of participants completing the intervention and follow-up measures, indicating its potential as a supportive care option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief, manualised and semistructured individual psychotherapy programme for patients with advanced cancer in Japan: study protocol for Managing Cancer and Living Meaningfully (CALM) phase 2 trial. Miyamoto, S., Yamazaki, T., Shimizu, K., et al.[2022]

The CALM psychotherapy program for patients with advanced cancer showed promising potential effects on reducing depressive symptoms and attachment anxiety, suggesting it may be beneficial for mental health in this population.

The study demonstrated feasibility for a larger phase 3 trial, with a 32% consent rate and 78% randomization, but highlighted challenges such as non-compliance (37%) and contamination (17%) that need to be addressed in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer. Lo, C., Hales, S., Chiu, A., et al.[2019]

Patients with advanced cancer often experience significant death-related distress, characterized by fears of uncertainty and suffering, which they find difficult to communicate due to personal and relational barriers.

The CALM therapy is perceived to effectively facilitate discussions about death and dying, helping patients express their distress and improve communication with healthcare providers and loved ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Death talk and relief of death-related distress in patients with advanced cancer. An, E., Wennberg, E., Nissim, R., et al.[2020]

The CALM therapy for advanced cancer patients was generally applied as intended, with therapists frequently addressing symptoms and emotional concerns, but there were notable deviations in adherence to specific treatment elements, such as promoting the acknowledgment of unachievable life goals.

No significant differences were found in the treatment elements delivered by CALM therapists compared to those in the supportive psycho-oncological counseling intervention (SPI), indicating that both therapies may share overlapping components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Treatment Integrity of the Managing Cancer and Living Meaningfully Psychotherapeutic Intervention for Patients With Advanced Cancer. Koranyi, S., Philipp, R., Quintero Garzón, L., et al.[2022]

The CALM-Nurses (CALM-N) training program is feasible and acceptable for oncology nurses, enhancing their ability to provide psychological support to advanced cancer patients, as evidenced by participation rates and positive feedback from focus groups.

The training significantly increased nurses' self-efficacy in their roles, suggesting that CALM-N could improve nurse-patient communication and reflective practices, although it did not show significant changes in burnout or empathy levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Oncology Nurses a Psychosocial Intervention for Advanced Cancer: A Mixed-Methods Feasibility Study. van Klinken, M., Hafkamp, E., Gualtherie van Weezel, A., et al.[2023]

Lethal means safety counseling (LMSC) is an important suicide prevention strategy that encourages patients to limit access to lethal means, such as firearms and medications, but it is underutilized in clinical practice due to various contextual factors.

A systematic review of 19 qualitative studies revealed key themes influencing LMSC implementation, including the cultural significance of firearms to owners, the need for providers to demonstrate cultural competency, and the importance of individualizing the counseling approach to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perceptions of lethal means safety counseling: A qualitative systematic review. Khazanov, GK., Keddem, S., Hoskins, K., et al.[2023]

In a study of 209 firearm-owning members of the Mississippi National Guard, lethal means safety counseling (LMSC) significantly increased the use of new firearm locking devices among individuals with low to medium PTSD hyperarousal symptoms at a 6-month follow-up.

However, for individuals with high levels of hyperarousal symptoms, LMSC did not lead to increased use of locking devices, indicating that LMSC interventions may need to be tailored for those with elevated PTSD symptoms to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lethal means safety counseling among firearm-owning U.S. National Guard personnel: Hyperarousal symptoms as a moderator of treatment outcomes. Stanley, IH., Bryan, CJ., Bryan, AO., et al.[2023]

After receiving CALM training, 80% of non-physician counselors felt confident in counseling patients on safe storage of lethal means, indicating the training's effectiveness in improving comfort levels.

Half of the counselors believed that having a script for the counseling session was more beneficial for their comfort than the online training alone, suggesting that structured guidance may enhance the delivery of lethal means restriction counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counseling on Access to Lethal Means in the Emergency Department: A Script for Improved Comfort. Mueller, KL., Chirumbole, D., Naganathan, S.[2022]

Lethal means counseling significantly increased the adoption of safe firearm storage methods among Mississippi National Guard members, with 55% of participants using safer methods compared to 39% in the control group at 3 months.

Provision of cable locks also improved safe storage practices, with participants using an average of 1.41 storage methods compared to 1.11 in the control group at 3 months, and 59.8% of those with cable locks secured their firearms, compared to only 29.9% in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lethal Means Counseling, Distribution of Cable Locks, and Safe Firearm Storage Practices Among the Mississippi National Guard: A Factorial Randomized Controlled Trial, 2018-2020. Anestis, MD., Bryan, CJ., Capron, DW., et al.[2021]

A qualitative study involving 27 participants revealed that over half had personal experiences with suicidal ideation, highlighting the importance of understanding lived experiences in counseling.

Effective lethal means counseling for suicidal individuals should take into account their emotional state and the specific challenges they face in communication, which can improve engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lethal Means Counseling for Suicidal Adults in the Emergency Department: A Qualitative Study. Siry, BJ., Knoepke, CE., Ernestus, SM., et al.[2021]

A pilot trial of the Seeking Safety (SS) therapy involving 24 military service members showed significant improvements in PTSD symptoms and substance use, indicating its effectiveness for treating these comorbid conditions.

Participants reported high satisfaction with the SS therapy, suggesting it is a feasible intervention for military personnel dealing with PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeking Safety Pilot Outcome Study at Walter Reed National Military Medical Center. Najavits, LM., Lande, RG., Gragnani, C., et al.[2018]

In a study of active duty service members undergoing cognitive processing therapy (CPT) for PTSD, hyperarousal symptoms were found to be more persistent compared to other PTSD symptom clusters, with 69% of improved participants still experiencing these symptoms post-treatment.

Even among those who fully recovered from PTSD, 26% continued to report hyperarousal symptoms, suggesting that these symptoms may need additional targeted treatment beyond standard CPT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperarousal symptoms linger after successful PTSD treatment in active duty military. Miles, SR., Hale, WJ., Mintz, J., et al.[2023]

Cognitive Processing Therapy (CPT) significantly improved symptoms of military-related PTSD in veterans compared to usual treatment, as shown in a randomized controlled trial with 59 participants receiving 12 sessions of therapy.

CPT also led to greater reductions in anxiety, depression, and improvements in social relationships, with no reported adverse events, highlighting its safety and efficacy in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled effectiveness trial of cognitive processing therapy for military-related posttraumatic stress disorder. Forbes, D., Lloyd, D., Nixon, RD., et al.[2018]

In a study of 420 veterans with PTSD, those receiving Seeking Safety (SS) had a higher treatment completion rate (89%) compared to those receiving cognitive processing therapy (CPT) (50%), indicating SS may be more acceptable for veterans.

However, veterans who completed CPT showed significantly greater reductions in PTSD symptoms, as measured by the PTSD checklist, suggesting that while SS is easier to complete, CPT may be more effective in reducing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. Baig, MR., Ouyang, S., Mata-Galán, E., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Brief, manualised and semistructured individual psychotherapy programme for patients with advanced cancer in Japan: study protocol for Managing Cancer and Living Meaningfully (CALM) phase 2 trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer. [2019]

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

Death talk and relief of death-related distress in patients with advanced cancer. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Testing the Treatment Integrity of the Managing Cancer and Living Meaningfully Psychotherapeutic Intervention for Patients With Advanced Cancer. [2022]

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

Teaching Oncology Nurses a Psychosocial Intervention for Advanced Cancer: A Mixed-Methods Feasibility Study. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Stakeholder perceptions of lethal means safety counseling: A qualitative systematic review. [2023]

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

Lethal means safety counseling among firearm-owning U.S. National Guard personnel: Hyperarousal symptoms as a moderator of treatment outcomes. [2023]

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

Counseling on Access to Lethal Means in the Emergency Department: A Script for Improved Comfort. [2022]

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

Lethal Means Counseling, Distribution of Cable Locks, and Safe Firearm Storage Practices Among the Mississippi National Guard: A Factorial Randomized Controlled Trial, 2018-2020. [2021]

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

Lethal Means Counseling for Suicidal Adults in the Emergency Department: A Qualitative Study. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Seeking Safety Pilot Outcome Study at Walter Reed National Military Medical Center. [2018]

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

Hyperarousal symptoms linger after successful PTSD treatment in active duty military. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled effectiveness trial of cognitive processing therapy for military-related posttraumatic stress disorder. [2018]

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

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. [2021]