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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist active duty service members who visit the emergency department with suicidal thoughts or behaviors. It tests a new approach called Crisis Response Planning, where patients collaborate with providers to create a personal plan to recognize and manage distress that could lead to suicide. This approach is compared to usual emergency department treatments, which include screenings and referrals to mental health care. Active duty individuals with suicidal concerns who can speak English may be eligible to participate. As an unphased trial, participants contribute to innovative research that may enhance emergency care for those in crisis.

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 prior data suggests that Crisis Response Planning is safe for active duty service members at risk for suicide?

Previous studies have shown that Crisis Response Planning (CRP) is safe and effective. Research indicates that CRP can reduce the risk of suicide attempts by up to 76% compared to traditional crisis methods and quickly decrease suicidal thoughts. This plan involves working with a provider to create a personalized strategy, including ways to manage distress and a list of emergency contacts.

No significant negative effects have been reported with CRP. As a short therapeutic approach focused on safety planning, it is generally well-received by patients. In fact, more frequent use of CRP is linked to fewer suicidal thoughts and better emotional well-being.

The other part of the trial, Treatment as Usual, involves standard emergency department practices, such as checking for suicidal thoughts and creating a safety plan if needed. Both treatments aim to help individuals in crisis, with CRP offering a more personalized approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Crisis Response Planning (CRP) because it offers a personalized approach to managing suicide risk that goes beyond traditional methods. Unlike standard treatments, which often focus on screening and general safety planning, CRP involves a detailed narrative assessment with the patient, creating a tailored strategy to handle distressing situations. This method empowers patients by having them handwrite their own plan, including personal warning signs, emotion regulation strategies, and reasons for living, making it a potentially more engaging and impactful tool for preventing suicide attempts.

What evidence suggests that this trial's treatments could be effective for suicide risk?

Research has shown that Crisis Response Planning (CRP), one of the interventions in this trial, can quickly reduce suicidal thoughts and attempts. Studies indicate that CRP lowers the risk of suicide and leads to more positive feelings. People using CRP often report a fast decrease in suicidal thoughts. Another study found CRP effective when provided through telehealth services, helping to reduce suicidality. These findings suggest CRP can be a useful tool for managing suicide risk. Participants in this trial may receive CRP or be assigned to the Treatment as Usual arm, which involves existing clinical practices for managing suicide risk. ^{1 2 4 6 7}

Who Is on the Research Team?

Kristen H Walter, PhD

Principal Investigator

Naval Health Research Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10189833/

Effectiveness of Suicide Safety Planning Interventions

Evidence across a range of studies indicates that SSP is effective for reducing suicide behavior (SB) and ideation (SI).

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.

jamanetwork.com

jamanetwork.com/journals/jamapediatrics/fullarticle/2834286

Safety Planning Interventions for Suicide Prevention in ...

This systematic review and meta-analysis investigates the effectiveness of safety planning as a standalone intervention for suicide ...

4.

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 ...

5.

bmchealthservres.biomedcentral.com

bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11739-w

insights from a randomized control trial of crisis response plan ...

Both Crisis Response Plan and self-guided Safety Planning were found to lower suicidality after receiving them via telehealth services.

6.

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 ...

7.

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 ...