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

Trial Summary

What is the purpose of this trial?

Crisis Response Planning is an efficacious, one-session intervention that increases positive affect, decreases negative affect and psychiatric hospitalizations, and reduces suicide attempts by 76% among Servicemembers. Crisis Response Planning is hypothesized to reduce suicidality by identifying a variety of personalized strategies that are designed to strengthen and/or promote emotion regulation processes.Research in nonmilitary samples suggests the effectiveness of emotion regulation strategies varies across situations. The applicability of these findings to suicidality among Servicemembers is unknown. Improved understanding of what strategies work under which circumstances and for whom will significantly advance our ability to prevent suicide among Servicemembers. Hypotheses include: 1. Use of self-management strategies, thinking about reasons for living, and seeking social support at time t will be associated with significant reductions in suicidal ideation at time t+1. 2. Use of distraction, reappraisal, and interpersonal emotion regulation strategies at time t will be associated with significant reductions in suicidal ideation at time t+1. 3. Affect intensity and social context will significantly moderate the time-lagged effects of Crisis Response Planning and emotion regulation strategy use on suicidal ideation. 4. Distinct profiles of demographic (e.g., gender, age), historical (e.g., prior suicide attempts), and psychological characteristics (e.g., emotion dysregulation, symptom severity) will predict who experiences a decrease in suicidal ideation following the use of Crisis Response Planning and emotion regulation strategies. 5. (Exploratory): Individuals who utilize their Crisis Response Planning more frequently and perceive Crisis Response Planning as more effective will be more likely to engage in mental health treatment at follow-up.

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 data supports the effectiveness of the treatment Crisis Response Planning for Suicidal Thoughts?

Research shows that the Crisis Response Plan (CRP) is effective in reducing suicidal behaviors compared to usual treatments. Additionally, the Safety Planning Intervention (SPI), which is similar to CRP, has been found to significantly lower suicidal behavior by helping individuals manage crises and remove dangerous means. ^{1 2 3 4 5}

Is Crisis Response Planning safe for humans?

Safety planning, including Crisis Response Planning, is generally considered safe and is used in many clinical settings to help prevent suicide. It involves creating a plan to manage suicidal thoughts and has been shown to be effective in reducing suicidal behaviors. ^{1 3 6 7 8}

How is the Crisis Response Planning treatment different from other treatments for suicidal thoughts?

Crisis Response Planning (CRP) is unique because it involves creating a personalized plan to manage suicidal thoughts by identifying warning signs, coping strategies, and support networks, rather than relying on medication or traditional therapy sessions. It is a brief, structured intervention that can be used in various settings and has been shown to effectively reduce suicidal behaviors. ^{1 2 3 8 9}

Eligibility Criteria

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.

Ability and willingness to complete research-related activities remotely

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

2. 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]

3. Israel pubmed.ncbi.nlm.nih.gov

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

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

The alignment of law, practice and need in suicide prevention. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Safety Planning on Crisis Lines: Feasibility, Acceptability, and Perceived Helpfulness of a Brief Intervention to Mitigate Future Suicide Risk. [2022]

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

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

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

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

8. Canada pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

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