Crisis Response Planning for Suicide Risk

(ASPIS/CRP Trial)

Overseen By Pia R Khandekar, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: United States Naval Medical Center, San Diego

Disqualifiers: Acute intoxication, Psychosis, Mania, others

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

Compensation: Varies

Number of Visits: 1

Duration: Varies

700 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Crisis Response Planning for Suicide Risk?

Research on Joint Crisis Plans (JCPs), which are similar to Crisis Response Planning, shows they help patients feel more in control and improve their relationship with healthcare providers. This suggests that Crisis Response Planning could also be effective in managing suicide risk by promoting self-awareness and collaboration with care providers. ^{1 2 3 4 5}

Is Crisis Response Planning safe for humans?

Crisis Response Planning, also known as Safety Planning, is generally considered safe and is widely used in clinical settings to help prevent suicide. It is a brief intervention that has become an accepted practice, and there is no evidence suggesting it poses any safety risks to participants. ^{6 7 8 9 10}

How is the Crisis Response Planning treatment different from other treatments for suicide risk?

Crisis Response Planning (CRP) is unique because it involves creating a personalized plan to help individuals manage suicidal thoughts by identifying warning signs, coping strategies, and support networks. Unlike standard treatments, CRP focuses on immediate, practical steps to prevent suicide attempts and is often more effective in reducing suicidal behaviors. ^{6 7 10 11 12}

What is the purpose of this trial?

The study is a randomized trial comparing outcomes of active duty service members who present to the emergency department at risk for suicide and receive care from providers trained in crisis response planning versus those providing treatment as usual.

Research Team

Kristen H Walter, PhD

Principal Investigator

Naval Health Research Center

Eligibility Criteria

This trial is for active duty service members over 18 who visit the emergency department at NMCSD with concerns of suicidal thoughts or behaviors, can understand and speak English, and are able to consent. Those with impaired mental status preventing informed consent, like acute intoxication or psychosis, cannot participate.

Inclusion Criteria

Active duty service members

I am over 18 years old.

I am seeking help for thoughts or actions related to harming myself.

Exclusion Criteria

I am mentally capable of understanding and consenting to participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either Crisis Response Planning or Treatment as Usual interventions

Varies

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Regular follow-up visits

Treatment Details

Interventions

• Crisis Response Planning
• Treatment as Usual

Trial Overview The study compares two approaches: crisis response planning by specially trained providers versus standard care (treatment as usual) for military personnel at risk of suicide after visiting the emergency department.

Participant Groups

Group I: Crisis Response Planning Experimental Treatment 1 Intervention

CRP is a brief psychotherapeutic intervention that can be provided to patients at risk of suicidal behavior. When using the intervention, a provider works with the patient (1) to conduct a narrative assessment of the events preceding suicidal thoughts or behavior, and (2) to develop a personalized plan for identifying and managing distress that could escalate to a suicide attempt. The CRP, which is typically handwritten by the patient on an index card, includes personal warning signs of distress, emotion regulation strategies, reasons for living, and contact information for friends/family as well as professional (psychological/medical) and emergency resources.

Group II: Treatment as Usual Active Control 1 Intervention

Existing clinical practices in the emergency department include the following elements recommended by the VA/DoD Clinical Practice Guidelines: (1) all patients are screened for suicidal ideation at every visit; (2) for those with positive screens, a suicide risk assessment interview is conducted by a mental health professional; (3) a safety planning form with means restriction (such as the Stanley-Brown; Stanley \& Brown, 2012) is completed; and (4) patients are referred for follow-up mental health treatment as needed. Other elements of TAU could include behavioral and psychotropic interventions, referrals to specialty mental healthcare, and admission for psychiatric inpatient care.

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?

United States Naval Medical Center, San Diego

Lead Sponsor

Trials

110

Recruited

24,200+

Naval Health Research Center

Collaborator

Trials

21

Recruited

177,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

The priority during a crisis in healthcare is to ensure the ongoing care of the patient while addressing the incident through documentation, investigation, and communication with the patient and their family.

The follow-up protocol after a major incident varies based on the level of harm caused, and may include incident reporting, mental health consultations, and adherence to recommendations from root cause analyses to prevent future occurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crisis management during anaesthesia: recovering from a crisis. Bacon, AK., Morris, RW., Runciman, WB., et al.[2018]

The Joint Crisis Plan (JCP) is viewed as a valuable tool by both patients and healthcare providers, enhancing the therapeutic relationship and giving patients a greater sense of control over their illness, based on a study involving 184 JCPs and 24 interviews with patients and providers.

Despite its benefits, challenges such as insufficient staff training and difficulties in shared decision-making were identified, indicating areas for improvement in the implementation of JCPs in psychiatric care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Joint Crisis Plan: A Powerful Tool to Promote Mental Health. Lequin, P., Ferrari, P., Suter, C., et al.[2021]

A study involving 70 EIP practitioners and 12 interviews revealed that effective crisis planning in mental health services is centered around identifying early warning signs, triggers, and helpful treatments, but not all elements of crisis plans are deemed useful.

Collaboration with clients and caregivers, personalization, and self-management are crucial for effective crisis planning, yet barriers such as electronic record systems and time constraints hinder consistent application in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practitioner opinions of crisis plans within early intervention in psychosis services: A mixed methods study. Lonsdale, N., Webber, M.[2021]

Two Massachusetts hospital systems successfully implemented a Communication-and-Resolution Program (CRP) without increasing liability costs, highlighting the effectiveness of their approach to managing adverse events.

Key factors contributing to their success included strong support from leadership, extensive physician education, collaboration with liability insurers, and effective project management, suggesting that these elements are crucial for successful CRP implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ensuring successful implementation of communication-and-resolution programmes. Mello, MM., Roche, S., Greenberg, Y., et al.[2021]

The Assaulted Staff Action Program (ASAP) is a peer-help crisis intervention designed to support employees who have been victims of assaults, showing effectiveness in providing clinical support and reducing violence in the workplace.

Over eight years of implementation, ASAP has demonstrated cost-effectiveness in service delivery, addressing common challenges and solutions encountered in its operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Assaulted Staff Action Program (ASAP): common issues in fielding a team. Flannery, RB.[2019]

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]

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]

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]

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]

A systematic review of 22 studies found that suicide safety planning (SSP) is effective in reducing suicidal behavior and ideation, highlighting its importance as a suicide prevention strategy.

SSP can be delivered in various formats, including standard, enhanced, and electronically, but more research is needed to explore its impact on mental illness symptoms and resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Suicide Safety Planning Interventions: A Systematic Review Informing Occupational Therapy. Marshall, CA., Crowley, P., Carmichael, D., et al.[2023]

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]

References

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

Crisis management during anaesthesia: recovering from a crisis. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Joint Crisis Plan: A Powerful Tool to Promote Mental Health. [2021]

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

Practitioner opinions of crisis plans within early intervention in psychosis services: A mixed methods study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Ensuring successful implementation of communication-and-resolution programmes. [2021]

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

The Assaulted Staff Action Program (ASAP): common issues in fielding a team. [2019]

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

Use of crisis management interventions among suicidal patients: Results of a randomized controlled trial. [2022]

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

A randomized, controlled trial of the safety planning intervention: Research design and methods. [2022]

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

Integrating Safety Plans for Suicidal Patients Into Patient Portals: Challenges and Opportunities. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

Computer Administered Safety Planning for Individuals at Risk for Suicide: Development and Usability Testing. [2023]

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

Effectiveness of Suicide Safety Planning Interventions: A Systematic Review Informing Occupational Therapy. [2023]

11. Israel pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. [2022]

12. Netherlands 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. [2022]