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Protocol - Classification of Suicidal Ideation and Suicidal Behavior - Adult - Lifetime

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Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Description:

This protocol includes two subscales from the Baseline version of the Columbia-Suicide Severity Rating Scale© (C-SSRS): Severity of Suicidal Ideation and Suicidal Behavior. Both subscales provide definitions of suicidal ideation and behavior and corresponding probes. The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal, self-injurious behavior.

The Baseline version of the C-SSRS assesses lifetime suicidal ideation and behavior. This version is suitable as part of a patient’s first interview as part of a clinical study.

Protocol:

SUICIDAL IDEATION

Ask questions 1 and 2. If both are negative, proceed to "Suicidal Behavior" section. If the answer to question 2 is "yes," ask questions 3, 4, and 5. If the answer to question 1 and/or 2 is "yes," complete "Intensity of Ideation" section below.

Lifetime: Time He/She Felt Most Suicidal

1. Wish to be Dead

Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up.

Have you wished you were dead or wished you could go to sleep and not wake up?

If yes, describe:

Yes   No

□   □

2. Non-Specific Active Suicidal Thoughts

General, non-specific thoughts of wanting to end one’s life/commit suicide (e.g., "I’ve thought about killing myself") without thoughts of ways to kill oneself/associated methods, intent, or plan.

Have you actually had any thoughts of killing yourself?

If yes, describe:

Yes   No

□   □

3. Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act

Subject endorses thoughts of suicide and has thought of at least one method during the assessment period. This is different than a specific plan with time, place or method details worked out (e.g., thought of method to kill self but not a specific plan). Includes person who would say, "I thought about taking an overdose but I never made a specific plan as to when, where or how I would actually do it…and I would never go through with it."

Have you been thinking about how you might do this?

If yes, describe:

Yes   No

□   □

4. Active Suicidal Ideation with Some Intent to Act, without Specific Plan

Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to "I have the thoughts but I definitely will not do anything about them."

Have you had these thoughts and had some intention of acting on them?

If yes, describe:

Yes   No

□   □

5. Active Suicidal Ideation with Specific Plan and Intent

Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out.

Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?

If yes, describe:

Yes   No

□   □

SUICIDAL BEHAVIOR

(Check all that apply, so long as these are separate events; must ask about all types)

Lifetime

Actual Attempt:

A potentially self-injurious act committed with at least some wish to die, as a result of act. Behavior was in part thought of as method to kill oneself. Intent does not have to be 100%. If there is any intent/desire to die associated with the act, then it can be considered an actual suicide attempt. There does not have to be any injury or harm, just the potential for injury or harm. If person pulls trigger while gun is in mouth but gun is broken so no injury results, this is considered an attempt.

Inferring Intent: Even if an individual denies intent/wish to die, it may be inferred clinically from the behavior or circumstances. For example, a highly lethal act that is clearly not an accident so no other intent but suicide can be inferred (e.g., gunshot to head, jumping from window of a high floor/story). Also, if someone denies intent to die, but they thought that what they did could be lethal, intent may be inferred.

Have you made a suicide attempt?

Have you done anything to harm yourself?

Have you done anything dangerous where you could have died?

What did you do?

Did you______ as a way to end your life?

Did you want to die (even a little) when you_____?

Were you trying to end your life when you _____?

Or did you think it was possible you could have died from_____?

Or did you do it purely for other reasons/without ANY intention of killing yourself (like to relieve stress, feel better, get sympathy, or get something else to happen)? (Self-Injurious Behavior without suicidal intent)

If yes, describe:

Yes   No

□   □

Total # of Attempts

______

Has subject engaged in Non-Suicidal Self-Injurious Behavior?

Yes   No

□   □

Interrupted Attempt:

When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would have occurred).

Overdose: Person has pills in hand but is stopped from ingesting. Once they ingest any pills, this becomes an attempt rather than an interrupted attempt. Shooting: Person has gun pointed toward self, gun is taken away by someone else, or is somehow prevented from pulling trigger. Once they pull the trigger, even if the gun fails to fire, it is an attempt. Jumping: Person is poised to jump, is grabbed and taken down from ledge. Hanging: Person has noose around neck but has not yet started to hang-is stopped from doing so.

Has there been a time when you started to do something to end your life but someone or something stopped you before you actually did anything?

If yes, describe:

Yes   No

□   □

Total # of interrupted

______

Aborted Attempt:

When person begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-destructive behavior. Examples are similar to interrupted attempts, except that the individual stops him/herself, instead of being stopped by something else.

Has there been a time when you started to do something to try to end your life but you stopped yourself before you actually did anything?

If yes, describe:

Yes   No

□   □

Total # of aborted

______

Preparatory Acts or Behavior:

Acts or preparation towards imminently making a suicide attempt. This can include anything beyond a verbalization or thought, such as assembling a specific method (e.g., buying pills, purchasing a gun) or preparing for one’s death by suicide (e.g., giving things away, writing a suicide note).

Have you taken any steps towards making a suicide attempt or preparing to kill yourself (such as collecting pills, getting a gun, giving valuables away or writing a suicide note)?

If yes, describe:

Yes   No

□   □

Suicidal Behavior:

Suicidal behavior was present during the assessment period?

Yes   No

□   □

© 2008 Research Foundation for Mental Hygiene, Inc.

Scoring:

Columbia-Suicide Severity Rating Scale Scoring and Data Analysis Guide

Personnel and Training Required

This scale is intended to be used by individuals who have received training in its administration. The questions contained in the Columbia-Suicide Severity Rating Scale are suggested probes. Ultimately, the determination of the presence of suicidal ideation or behavior depends on the judgment of the individual administering the scale.

For inquiries and training requirements, please contact posnerk@nyspi.columbia.edu.

Equipment Needs

The PhenX Working Group acknowledges these questions can be administered in a computerized or non-computerized format (i.e., paper-and-pencil instrument). Computer software is necessary to develop computer-assisted instruments. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adult

Specific Instructions:

This protocol includes questions that can potentially identify respondents who are at risk of suicide. Investigators implementing this protocol should consider developing a risk management plan specific to their study to ensure the safety of participants. The following links provide additional information and guidelines for suicide-related research:

[link[ora.research.ucla.edu/OHRPP/Documents/Policy/8/Risk_of_Suicide.pdf|ora.research.ucla.edu/OHRPP/Documents/Policy/8/Risk_of_Suicide.pdf]]

[link[www.nimh.nih.gov/health/topics/suicide-prevention/issues-to-consider-in-intervention-research-with-persons-at-high-risk-for-suicidality.shtml|www.nimh.nih.gov/health/topics/suicide-prevention/issues-to-consider-in-intervention-research-with-persons-at-high-risk-for-suicidality.shtml]]

Research Domain Information

Release Date:

November 21, 2014

Definition

A questionnaire to assess suicidal ideation and suicidal behavior over a range of time frames.

Purpose

Suicidal ideation and suicidal behavior can indicate an increased risk of suicide attempts and death by suicide. This measure can be used to determine levels of suicide risk and aid in making clinical decisions about care. In contrast to the PhenX measure Intensity of Suicidal Ideation (Continuum), which considers suicidal ideation existing as a continuous scale within a single construct, this measure distinguishes and classifies suicidal ideation and behavior, separately.

Selection Rationale

The Columbia-Suicide Severity Rating Scale© (C-SSRS) is widely used in clinical trials, is low burden to participants and researchers, is not proprietary for non-industry-sponsored research, and has training materials available. Additionally, the C-SSRS corresponds to definitions for suicidal ideation and suicidal behavior endorsed by the Centers for Disease Control and Prevention (Crosby et al., 2011) and the U.S. Food and Drug Administration (FDA -Guidance for Industry Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration, 2012).

Language

English, Available in other languages

Standards

StandardNameIDSource
Common Data Elements (CDE)Adult Lifetime Suicidal Ideation Behavior Classification Questionnaire Score4588762CDE Browser

Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

The Columbia-Suicide Severity Rating Scale (C-SSRS) is copyrighted by the Research Foundation for Mental Hygiene, Inc.

For reprints of the C-SSRS contact:

Kelly Posner, PhD

New York State Psychiatric Institute

1051 Riverside Drive

New York City, NY 10032

General References

Center for Drug Evaluation and Research (CDER). (2012). Guidance for industry suicidal ideation and behavior: Prospective assessment of occurrence in clinical trials. Rockville, MD: U.S. Department of Health and Human Services, U.S. Food and Drug Administration.

Crosby, A. E., Ortega, L., & Melanson, C. (2011). Self-directed violence surveillance: Uniform definitions and recommended data elements, Version 1.0. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control.

Mundt, J. C., Greist, J. H., Jefferson, J. W., Federico, M., Mann, J. J., & Posner K. (2013). Prediction of suicidal behavior in clinical research by lifetime suicidal ideation and behavior ascertained by the electronic Columbia-Suicide Severity Rating Scale. Journal of Clinical Psychiatry, 74(9), 887-893.

Posner, K., Brown, G. K., Stanley, B., Brent, D. A., Yershova, K. V., Oquendo, M. A., Currier, G. W., Melvin, G., Greenhill, L., Shen, S., & Mann, J. J. (2011). The Columbia-Suicide Severity Rating Scale: Initial validity and internal consistency findings from three multisite studies with adolescents and adults. American Journal of Psychiatry, 168(12), 1266-1277.

Protocol ID:

640106

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX640106_Suicide_Interrupted_Attempt_LifetimePX640106150000When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would have occurred). Overdose: Person has pills in hand but is stopped from ingesting. Once they ingest any pills, this becomes an attempt rather than an interrupted attempt. Shooting: Person has gun pointed toward self, gun is taken away by someone else, or is somehow prevented from pulling trigger. Once they pull the trigger, even if the gun fails to fire, it is an attempt. Jumping: Person is poised to jump, is grabbed and taken down from ledge. Hanging: Person has noose around neck but has not yet started to hang - is stopped from doing so. Has there been a time when you started to do something to end your life but someone or something stopped you before you actually did anything?4N/A
PX640106_Suicide_Interrupted_Attempt_Lifetime_DescribePX640106160000When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would have occurred). Overdose: Person has pills in hand but is stopped from ingesting. Once they ingest any pills, this becomes an attempt rather than an interrupted attempt. Shooting: Person has gun pointed toward self, gun is taken away by someone else, or is somehow prevented from pulling trigger. Once they pull the trigger, even if the gun fails to fire, it is an attempt. Jumping: Person is poised to jump, is grabbed and taken down from ledge. Hanging: Person has noose around neck but has not yet started to hang - is stopped from doing so. Has there been a time when you started to do something to end your life but someone or something stopped you before you actually did anything? If yes, describe:4N/A
PX640106_Suicide_Interrupted_Attempt_TotalNumber_LifetimePX640106170000Total number of interrupted4N/A
PX640106_Suicide_Aborted_Attempt_LifetimePX640106180000When person begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-destructive behavior. Examples are similar to interrupted attempts, except that the individual stops him/herself, instead of being stopped by something else. Has there been a time when you started to do something to try to end your life but you stopped yourself before you actually did anything?4N/A
PX640106_Suicide_Aborted_Attempt_Lifetime_DescribePX640106190000When person begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-destructive behavior. Examples are similar to interrupted attempts, except that the individual stops him/herself, instead of being stopped by something else. Has there been a time when you started to do something to try to end your life but you stopped yourself before you actually did anything? If yes, describe:4N/A
PX640106_Suicide_Aborted_Attempt_TotalNumber_LifetimePX640106200000Total number of aborted4N/A
PX640106_Suicide_Preparatory_Acts_Behavior_LifetimePX640106210000Acts or preparation towards imminently making a suicide attempt. This can include anything beyond a verbalization or thought, such as assembling a specific method (e.g., buying pills, purchasing a gun) or preparing for one¿¿¿s death by suicide (e.g., giving things away, writing a suicide note). Have you taken any steps towards making a suicide attempt or preparing to kill yourself (such as collecting pills, getting a gun, giving valuables away or writing a suicide note)?4N/A
PX640106_Suicide_Preparatory_Acts_Behavior_Lifetime_DescribePX640106220000Acts or preparation towards imminently making a suicide attempt. This can include anything beyond a verbalization or thought, such as assembling a specific method (e.g., buying pills, purchasing a gun) or preparing for one¿¿¿s death by suicide (e.g., giving things away, writing a suicide note). Have you taken any steps towards making a suicide attempt or preparing to kill yourself (such as collecting pills, getting a gun, giving valuables away or writing a suicide note)? If yes, describe:4N/A
PX640106_Suicidal_Behavior_Present_Assessment_PeriodPX640106230000Suicidal behavior was present during the assessment period?4N/A
PX640106_Wish_ToBe_Dead_LifetimePX640106010000Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up. Have you wished you were dead or wished you could go to sleep and not wake up?4N/A
PX640106_Wish_ToBe_Dead_Lifetime_DescribePX640106020000Subject endorses thoughts about a wish to be dead or not alive anymore, or wish to fall asleep and not wake up. Have you wished you were dead or wished you could go to sleep and not wake up? If yes, describe:4N/A
PX640106_SuicidalThoughts_Nonspecific_Active_Lifetime_DescribePX640106040000General, non-specific thoughts of wanting to end one¿¿¿s life/commit suicide (e.g., ¿¿¿I¿¿¿ve thought about killing myself¿¿¿) without thoughts of ways to kill oneself/associated methods, intent, or plan during the assessment period. Have you actually had any thoughts of killing yourself? If yes, describe:4N/A
PX640106_SuicidalIdeation_WithMethods_WithoutIntent_LifetimePX640106050000Subject endorses thoughts of suicide and has thought of at least one method during the assessment period. This is different than a specific plan with time, place or method details worked out (e.g., thought of method to kill self but not a specific plan). Includes person who would say, ¿¿¿I thought about taking an overdose but I never made a specific plan as to when, where or how I would actually do it¿¿¿..and I would never go through with it.¿¿¿ Have you been thinking about how you might do this?4N/A
PX640106_SuicidalIdeation_WithMethods_WithoutIntent_Lifetime_DescribePX640106060000Subject endorses thoughts of suicide and has thought of at least one method during the assessment period. This is different than a specific plan with time, place or method details worked out (e.g., thought of method to kill self but not a specific plan). Includes person who would say, ¿¿¿I thought about taking an overdose but I never made a specific plan as to when, where or how I would actually do it¿¿¿..and I would never go through with it.¿¿¿ Have you been thinking about how you might do this? If yes, describe:4N/A
PX640106_SuicidalIdeation_WithIntent_WithoutPlan_LifetimePX640106070000Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to ¿¿¿I have the thoughts but I definitely will not do anything about them.¿¿¿ Have you had these thoughts and had some intention of acting on them?4N/A
PX640106_SuicidalIdeation_WithIntent_WithoutPlan_Lifetime_DescribePX640106080000Active suicidal thoughts of killing oneself and subject reports having some intent to act on such thoughts, as opposed to ¿¿¿I have the thoughts but I definitely will not do anything about them.¿¿¿ Have you had these thoughts and had some intention of acting on them? If yes, describe:4N/A
PX640106_SuicidalIdeation_WithIntent_WithPlan_LifetimePX640106090000Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out. Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?4N/A
PX640106_SuicidalIdeation_WithIntent_WithPlan_Lifetime_DescribePX640106100000Thoughts of killing oneself with details of plan fully or partially worked out and subject has some intent to carry it out. Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan? If yes, describe:4N/A
PX640106_Suicide_Actual_Attempt_LifetimePX640106110000A potentially self-injurious act committed with at least some wish to die, as a result of act. Behavior was in part thought of as method to kill oneself. Intent does not have to be 100%. If there is any intent/desire to die associated with the act, then it can be considered an actual suicide attempt. There does not have to be any injury or harm, just the potential for injury or harm. If person pulls trigger while gun is in mouth but gun is broken so no injury results, this is considered an attempt. Inferring Intent: Even if an individual denies intent/wish to die, it may be inferred clinically from the behavior or circumstances. For example, a highly lethal act that is clearly not an accident so no other intent but suicide can be inferred (e.g., gunshot to head, jumping from window of a high floor/story). Also, if someone denies intent to die, but they thought that what they did could be lethal, intent may be inferred. Have you made a suicide attempt? Have you done anything to harm yourself? Have you done anything dangerous where you could have died? What did you do? Did you___ as a way to end your life? Did you want to die (even a little) when you___? Were you trying to end your life when you ___? Or did you think it was possible you could have died from___? Or did you do it purely for other reasons / without ANY intention of killing yourself (like to relieve stress, feel better, get sympathy, or get something else to happen)? (Self-Injurious Behavior without suicidal intent)4N/A
PX640106_Suicide_Actual_Attempt_Lifetime_DescriptionPX640106120000A potentially self-injurious act committed with at least some wish to die, as a result of act. Behavior was in part thought of as method to kill oneself. Intent does not have to be 100%. If there is any intent/desire to die associated with the act, then it can be considered an actual suicide attempt. There does not have to be any injury or harm, just the potential for injury or harm. If person pulls trigger while gun is in mouth but gun is broken so no injury results, this is considered an attempt. Inferring Intent: Even if an individual denies intent/wish to die, it may be inferred clinically from the behavior or circumstances. For example, a highly lethal act that is clearly not an accident so no other intent but suicide can be inferred (e.g., gunshot to head, jumping from window of a high floor/story). Also, if someone denies intent to die, but they thought that what they did could be lethal, intent may be inferred. Have you made a suicide attempt? Have you done anything to harm yourself? Have you done anything dangerous where you could have died? What did you do? Did you___ as a way to end your life? Did you want to die (even a little) when you___? Were you trying to end your life when you ___? Or did you think it was possible you could have died from___? Or did you do it purely for other reasons / without ANY intention of killing yourself (like to relieve stress, feel better, get sympathy, or get something else to happen)? (Self-Injurious Behavior without suicidal intent) If yes, describe:4N/A
PX640106_Suicide_Actual_Attempt_TotalNumber_LifetimePX640106130000Total number of attempts4N/A
PX640106_NonSuicidal_SelfInjurious_Behavior_LifetimePX640106140000Has subject engaged in Non-Suicidal Self-Injurious Behavior?4N/A
PX640106_SuicidalThoughts_Nonspecific_Active_LifetimePX640106030000General, non-specific thoughts of wanting to end one¿¿¿s life/commit suicide (e.g., ¿¿¿I¿¿¿ve thought about killing myself¿¿¿) without thoughts of ways to kill oneself/associated methods, intent, or plan during the assessment period. Have you actually had any thoughts of killing yourself?4N/A