Crisis Response Planning for Suicidal Thoughts

Overseen By Lauren Khazem, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Psychotropic medications

Disqualifiers: Psychosis, Mania, Acute intoxication, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

334 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a one-time intervention called Crisis Response Planning to reduce suicidal thoughts and actions among U.S. military personnel. The approach focuses on creating personalized strategies for managing emotions, finding reasons to live, and seeking social support. Participants will also receive Lethal Means Safety Counseling, which involves guidance on limiting access to dangerous items that could be used for self-harm. The trial seeks active service members who have recently experienced suicidal thoughts or attempts and have not engaged in mental health treatments in the past year. As an unphased trial, this study offers participants the chance to contribute to innovative approaches in mental health care.

Will I have to stop taking my current medications?

The trial excludes participants who have engaged in mental health treatment, including taking psychotropic medications, within the past year. This suggests that you may need to stop taking such medications to participate.

What prior data suggests that Crisis Response Planning is safe for Servicemembers?

Research has shown that Crisis Response Planning (CRP) is a safe and effective method for helping people with suicidal thoughts. Studies have found that CRP can quickly reduce these thoughts and attempts. It helps individuals manage difficult emotions and can lower suicide attempts by up to 76%. This indicates it is generally well-tolerated and does not cause harm.

Research also supports Lethal Means Safety Counseling as a safe practice to reduce suicide risk. This counseling involves learning how to safely store items like firearms to prevent harm. It increases knowledge and skills without any negative effects. Both CRP and Lethal Means Safety Counseling aim to reduce risk and have been shown to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Crisis Response Planning for addressing suicidal thoughts because it takes a personalized, proactive approach. Unlike standard treatments like medication or traditional talk therapy, this method involves creating a tailored plan with individuals to identify their unique warning signs and coping strategies. It also emphasizes the importance of lethal means counseling, which involves actively working to limit access to potential means of self-harm. This collaborative and hands-on approach can empower individuals by giving them practical tools and immediate steps to take during a crisis, potentially leading to better outcomes.

What evidence suggests that Crisis Response Planning is effective for reducing suicidality among Servicemembers?

Research shows that Crisis Response Planning (CRP), which participants in this trial will engage in, effectively reduces suicidal thoughts and attempts. Studies have found that CRP can quickly decrease thoughts of suicide and reduce attempts by up to 76% compared to traditional methods. Frequent use of CRP is linked to fewer suicidal thoughts and more positive feelings. This method involves creating a personal plan to handle crises, helping individuals manage emotions better. It improves emotional management by identifying personal warning signs, calming strategies, and sources of support from others. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for U.S. military members over 18 who can do activities remotely, have regular smartphone access, and are experiencing suicidal thoughts or behaviors. It's not for those with conditions affecting consent, planning to leave the military within 90 days, or in mental health treatment recently.

Inclusion Criteria

Score ≥ 5 on the Scale for Suicidal Ideation and/or endorse a recent suicide attempt on the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)

I am older than 18 years.

Currently serving in any Branch or Component of the U.S. military

Exclusion Criteria

Presence of a psychiatric or medical condition that prevents providing informed consent or participating in treatments (e.g., psychosis, mania, acute intoxication)

Expecting to separate from the military within 90 days

I have been in mental health treatment or taken psychiatric medication in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete a narrative suicide risk assessment, develop a Crisis Response Plan, and receive lethal means counseling

1 session

1 visit (in-person)

Ecological Momentary Assessment

Participants are assessed for suicidal ideation over 28 consecutive days

4 weeks

Follow-up

Participants are monitored for changes in suicidal ideation at multiple time points

12 months

Follow-up assessments at 1, 2, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Crisis Response Planning
• Lethal Means Safety Counseling

Trial Overview The study tests Crisis Response Planning and Lethal Means Safety Counseling to see if they help reduce suicidal thoughts by improving how individuals manage their emotions. The effectiveness of different strategies under various situations will be examined.

How Is the Trial Designed?

Group I: Crisis Response Plan and Lethal Means Counseling Experimental Treatment 1 Intervention

All participants will complete a narrative suicide risk assessment, collaboratively develop a Crisis Response Plan, and receive lethal means counseling. The Crisis Response Plan will include the following sections: (1) identifying personal warning signs for suicide; (2) identifying self-regulation strategies for reducing emotional distress; (3) identifying reasons for living; (4) identifying sources of social support; and (5) accessing professional crisis services. Participants will handwrite the plan on an index card, sheet of paper, or another similar medium. After completing the Crisis Response Planning, researchers will conduct lethal means counseling to develop a plan for restricting or limiting access to potentially lethal methods of suicide.

Crisis Response Planning is already approved in United States for the following indications:

Approved in United States as Crisis Response Planning for:

• Suicide Prevention
• Posttraumatic Stress Disorder (PTSD) Management

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

A self-administered, Web-based safety planning application was developed and tested with 30 suicidal patients, showing strong usability ratings and enabling 90% of participants to complete at least 5 out of 6 safety planning steps.

Participants reported a significant decrease in suicidal ideation intensity after using the application, with pre-application scores averaging 5.11 and post-application scores averaging 4.46, indicating the potential effectiveness of this tool in enhancing coping abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer Administered Safety Planning for Individuals at Risk for Suicide: Development and Usability Testing. Boudreaux, ED., Brown, GK., Stanley, B., et al.[2023]

Safety planning is an effective evidence-based practice that can significantly reduce suicidal behaviors, highlighting its importance in mental health care.

Integrating safety plans into electronic patient portals at health centers, like the Institute for Family Health, offers a promising method to enhance safety planning efforts and potentially save lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Safety Plans for Suicidal Patients Into Patient Portals: Challenges and Opportunities. Little, V., Neufeld, J., Cole, AR.[2019]

Coping planning is proposed as a new approach to suicide prevention, shifting the focus from traditional safety planning to enhancing patients' coping skills and self-efficacy during acute distress.

This strategy emphasizes 'caring', 'collaborating', and 'connecting' to reinforce patients' strengths and provide necessary support, potentially leading to better outcomes and reduced risk of suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping planning: a patient-centred and strengths-focused approach to suicide prevention training. Stallman, HM.[2022]

The traditional risk management approach for patients with suicidal thoughts may inadvertently increase stigma and limit support, which can discourage future help-seeking.

Coping planning is suggested as a more effective alternative, as it emphasizes the strengths and needs of patients, potentially improving their willingness to seek help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The alignment of law, practice and need in suicide prevention. Stallman, HM., Ohan, JL.[2020]

In a study involving 97 active-duty U.S. Army personnel, both standard and enhanced crisis response plans (CRPs) were found to be highly acceptable and useful, with over 80% of participants retaining their written plans for up to 6 months.

More frequent use and better recall of the enhanced CRP, which includes reasons for living, were linked to significantly lower levels of suicidal thoughts compared to treatment as usual, highlighting its potential effectiveness in reducing suicide ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of crisis management interventions among suicidal patients: Results of a randomized controlled trial. Bryan, CJ., May, AM., Rozek, DC., et al.[2022]

The Safety Planning Intervention (SPI) was found to be feasible and helpful by 271 crisis counselors across five centers in the National Suicide Prevention Lifeline network, indicating its potential for use in crisis hotlines.

Counselors reported that SPI was effective in both incoming and follow-up calls, suggesting it could help reduce future suicide risk, although further research is needed to establish its efficacy through randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Planning on Crisis Lines: Feasibility, Acceptability, and Perceived Helpfulness of a Brief Intervention to Mitigate Future Suicide Risk. Labouliere, CD., Stanley, B., Lake, AM., et al.[2022]

This study is set to evaluate the effectiveness of the Safety Planning Intervention for reducing suicidal behavior in patients aged 18 and older who present with suicide-related emergencies in emergency departments, with a target sample size of 484 participants.

The trial will compare the Safety Planning Intervention to a control group that reviews risk factors and warning signs, assessing outcomes at 1, 3, and 6 months to determine the intervention's impact on suicidal behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of the safety planning intervention: Research design and methods. Boudreaux, ED., Stanley, B., Green, KL., et al.[2022]

The Safety Planning Intervention (SPI) is a structured six-step action plan designed to help individuals at risk of suicide by enhancing their coping strategies and social support, and by removing access to means of self-harm.

Research shows that SPI is highly effective in reducing suicidal behavior, making it a valuable tool in various settings such as emergency rooms and outpatient clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. Perlstein, J., Katzir, N., Lotan, A., et al.[2022]

Crisis response planning significantly reduced the incidence of suicide attempts among active duty Army Soldiers, with only 5% of participants using this plan attempting suicide compared to 19% using a contract for safety, indicating a 76% reduction in attempts.

Participants who received crisis response planning experienced a faster decline in suicidal thoughts and fewer days in inpatient care, demonstrating its effectiveness in improving mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of crisis response planning vs. contracts for safety on suicide risk in U.S. Army Soldiers: A randomized clinical trial. Bryan, CJ., Mintz, J., Clemans, TA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12429010/

Comparing the Impacts of Crisis Response Plan and Self‐ ... More frequent CRP use was linked with lower risk of suicidal ideation and greater positive affect. This may reflect better plan use due to ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0887618523001627

Crisis response planning rapidly reduces suicidal ideation ... Crisis response planning (CRP), a brief safety planning-type intervention, has been shown to rapidly reduce suicidal ideation and suicide attempts.

3. suicidepreventiontherapy.com suicidepreventiontherapy.com/crisis-response-planning-1

Crisis Response Planning (CRP) - Suicide Prevention Therapy CRP is a specific kind of safety planning-type intervention that has been shown to reduce suicide attempts by up to 76% as compared to traditional crisis ...

4. continuum.militaryfamilies.psu.edu continuum.militaryfamilies.psu.edu/program/Crisis%20Response%20Planning%20(CRP)

Crisis Response Planning (CRP) - Continuum of Evidence Results indicated that the S-CRP and E-CRP groups experienced significant reductions in suicide attempts, significantly faster decline in suicide ideation, and ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/sltb.70050

Comparing the Impacts of Crisis Response Plan and Self ... More frequent CRP use was linked with lower risk of suicidal ideation and greater positive affect. This may reflect better plan use due to ...

6. mirecc.va.gov mirecc.va.gov/visn19/cpg/recs/7/

7: Crisis Response Planning and Safety Planning Crisis Response Plans (CRP) and Safety Planning (SPI) both include step-by-step instructions to use prior to or during a suicidal crisis.