What is the mechanism of action of this treatment?

Crisis Response Planning (CRP) and similar interventions work by providing structured planning and coping strategies to manage crises. These treatments involve identifying personal warning signs, developing internal coping mechanisms, and creating a list of contacts and resources for support during a crisis. This approach is crucial for suicide patients as it helps reduce immediate risk by offering concrete steps to follow during moments of acute distress, thereby enhancing their sense of control and preparedness. By having a clear plan, patients can better manage their emotions and reduce the likelihood of acting on suicidal impulses.

What side effects are associated with this type of intervention?

The most common treatments for managing crises in suicidal patients, such as Crisis Response Planning (CRP), cognitive-behavioral therapy (CBT), and dialectical behavior therapy (DBT), are generally well-tolerated with minimal side effects. However, some patients may experience increased emotional distress or anxiety as they confront and process difficult emotions and memories during therapy sessions. Additionally, there can be a temporary increase in suicidal thoughts or behaviors as patients begin to engage with the therapeutic process. It is crucial for these therapies to be conducted by trained professionals who can monitor and manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has not specifically approved any medications solely for the prevention of suicide. However, treatments such as antidepressants (e.g., SSRIs like fluoxetine and sertraline) are commonly used to manage underlying conditions like depression and anxiety, which can reduce suicidal ideation. Structured interventions like Crisis Response Planning (CRP), which involve creating detailed plans and coping strategies to manage crises, are being studied for their effectiveness in reducing suicide risk. These non-pharmacological approaches focus on immediate and practical steps to enhance safety and emotional regulation during crises.

What other types of research exist?

Promising novel alternatives to Crisis Response Planning for suicide patients include: 1) Digital mental health interventions such as mobile apps and online therapy platforms that provide real-time support and coping strategies. 2) Brief Cognitive Behavioral Therapy (CBT) interventions tailored for crisis situations. 3) Dialectical Behavior Therapy (DBT) skills training, which focuses on emotion regulation and distress tolerance. 4) Collaborative Assessment and Management of Suicidality (CAMS), a therapeutic framework that involves patients in their own treatment planning. 5) Use of telehealth services to provide immediate access to mental health professionals during crises.

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Crisis Response Planning for Suicide Prevention

N/A

Recruiting

Led By Stephanie Gorka, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older at the time of consent

Be older than 18 years old

Must not have

Medical or neurologic condition or neurocognitive dysfunction that would interfere with the study

Under 18 years old at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment, post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a one-hour session of Crisis Response Planning (CRP) can help adults with suicidal thoughts by giving them a personalized plan to manage their feelings. The study compares CRP to other methods to see which is more effective in reducing suicide risk over time.

Who is the study for?

Adults with current suicidal intent, as indicated by a score of 5 or more on the Beck's Scale for Suicidal Ideation. Participants must be generally healthy and able to give informed consent. Excluded are those with certain mental health conditions, pregnant women, individuals under drug influence during scans, people uncomfortable in small spaces, non-English speakers, and anyone with metal implants.

What is being tested?

The study compares two suicide prevention strategies: a one-hour session of Crisis Response Planning (CRP) versus standard crisis risk management. The impact on emotion regulation and suicide risk is assessed immediately after and six months post-intervention. Daily mood checks occur for the first ten days then monthly up to six months.

What are the potential side effects?

Since this trial involves counseling interventions rather than medications or medical procedures, traditional side effects are not applicable. However, participants may experience emotional discomfort discussing sensitive topics like suicidality.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health conditions that would affect my participation in the study.

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I am younger than 18.

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I have had a traumatic brain injury from a suicide attempt or another event.

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I am deaf in one or both ears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment, post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment, post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, post-treatment, 1-week post-intervention, monthly post-intervention, and 6-months post-intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frontolimbic neural circuit activation and connectivity

Suicidality

Secondary study objectives

Markers of negative affectivity

Mood and psychiatric symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Crisis Response Planning (CRP)Experimental Treatment1 Intervention

The crisis response planning (CRP) session will last between 30 minutes to 1-hour. It will occur face-to-face with a trained study therapist. The CRP session involves the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The CRP active component involves a collaborative process in which the therapist invites the patient to share the events, symptoms, and contextual factors leading up to and surrounding the participant's suicidal crisis. Next, the patient and therapist identify the patient's personal warning signs for an emotional crisis, self-management coping skills, patient's reasons for living, and sources of social support. These components are written, by the patient, on an index card. The index card serves as a concrete reference for patients in the real-world.

Group II: ControlActive Control1 Intervention

Individuals who have not experienced suicidal ideation will not complete a suicide intervention.

Group III: Crisis Risk CounselingActive Control1 Intervention

The crisis risk counseling session will last between 30 minutes to 1-hour. It will occur face-to-face with a trained study therapist. It will include the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The therapist will conduct a semi-structured suicide risk assessment interview, after which subjects will complete a self-guided safety plan worksheet. The worksheet takes approximately 10-minutes to complete and will be done independently.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Crisis Response Planning (CRP) and similar interventions work by providing structured planning and coping strategies to manage crises. These treatments involve identifying personal warning signs, developing internal coping mechanisms, and creating a list of contacts and resources for support during a crisis. This approach is crucial for suicide patients as it helps reduce immediate risk by offering concrete steps to follow during moments of acute distress, thereby enhancing their sense of control and preparedness. By having a clear plan, patients can better manage their emotions and reduce the likelihood of acting on suicidal impulses.