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D059020 Suicidal Ideation NIH 1.00

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There is one clinical trial.

Clinical Trials


1 Assessing Actigraphy-Determined Movement Variability as a Novel Objective Marker

This is a research project looking at whether measuring movements or responses to certain questions can help predict suicidal thoughts or actions. This project has two parts: The first part will occur while the participant is receiving hospitalized at the Bedford VA Hospital. It involves wearing a watch-like device on his/her wrist and answering questions or doing tasks to measure mood and other mental health symptoms, and suicidal thoughts. In the second phase, the investigators will call the participant around 12 months after s/he has left the hospital. The investigators will discuss how s/he is doing and if s/he has had suicidal thoughts or made suicidal acts.

NCT03080168 Suicidal Ideation Suicidal Behavior Mental Health Symptoms Mental Health Hospitalizations Device: Actigraph
MeSH:Suicidal Ideation

Primary Outcomes

Description: The investigators will call some participants who are not undergoing alcohol detoxification and administer the Columbia-Suicide Severity Rating Scale to determine occurrence of all suicidal behavior (actual, interrupted, aborted, and preparatory), ask them to also self-report rehospitalization with suicidal ideation (SI), and use VA chart data as another source of information about suicidal behavior and rehospitalization. For those patients who we reach by phone we will use both their self-report and the information from chart review to inform this outcome, and from those patients not undergoing analysis who we don't reach, or those who are in participant groups not receiving phone calls (the participants undergoing alcohol detoxification). The data will then be reconciled and combined into a measure of Suicidal Behavior or rehospitalization with suicidal ideation over the 12 months since discharge.

Measure: POST DISCHARGE FOLLOW-UP (COMPOSITE): CSSRS Suicidal Behaviors (self-report), Rehospitalization with Suicidal Ideation (self-report), combined with chart data re Suicidal Behavior and Rehospitalization with Suicidal Ideation

Time: 12 months since discharge from index hospitalization

Description: Association of Actigraph measurements with Sheehan STS Scale

Measure: INPATIENT: Sheehan STS scale

Time: Last 24 hours up to assessment

Secondary Outcomes

Description: Participants rank the Severity and Duration of their suicidal thinking on 0-10 scales each day, This outcome will look at the distribution of the interaction between the scores (e.g., multiplicative/multiplication of scores) and determine whether that simple interaction/combination will be used, log or otherwise transformed, and/or more weighting given to duration than severity, etc. This determination will be made on the spread of this data, not any information about how it correlates with actigraphy or other data gathered. This is being designated a secondary outcome simply because how the measure will be determined is not yet specified, but it is expected that this composite measure will likely have a stronger association with actigraphy and other RFs (risk factors)/predictors than simply the severity of suicidal ideation, one of the co-primary outcomes.

Measure: INPATIENT: Self-report response to Suicidal thinking diary questions re Combined Severity and Duration of suicidal thinking [Main Secondary Analysis]

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: The investigators will use the data gathered from the CSSRS from phone interviews and chart review to determine the occurrence of Actual Suicidal Behavior in the 12 months since discharge. We will use both sources of information to assess those patients who are reached by phone and the chart review alone for those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls).

Measure: POST DISCHARGE FOLLOW-UP: Actual Suicidal Behavior (self-report and chart informed) [Main Secondary]

Time: 12 months (12 months since discharge from index hospitalization)

Description: The investigators will call patients and administer CSSRS to determine, and ask about rehospitalization with SI, as well as determine information from the chart about the occurrence of these outcomes, both for patients who are reached by phone and those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls).

Measure: POST-DISCHARGE FOLLOW-UP: All Suicidal Behavior plus Rehospitalization plus Severity of Worst Suicidal Ideation (Some Intent or Some Intent or Plan) [Main Secondary]

Time: 12 months since Discharge

Description: Daily rankings of Severity of Suicidal Ideation, from the Suicidal Thinking Diary, on a scale of 0-10.

Measure: INPATIENT: Severity of Suicidal Ideation

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days [It is anticipated most subjects will provide from 2-7 days of data)

Description: Daily rankings of Duration of Suicidal Ideation, from the Suicidal Thinking Diary, on a scale of 0-10.

Measure: INPATIENT: Duration of Suicidal Ideation (Thinking Diary)

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Daily rankings of Duration of Suicidal Ideation, from the Sheehan Tracking Scale, in hours and minutes.

Measure: INPATIENT: Duration of Suicidal Ideation (Hours/minutes)

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Maximum Level of Suicidal Ideation per CSSRS 5 Level scale (ranging from Wish to be Dead to Active Ideation with Intent and Plan).

Measure: INPATIENT: Maximum Level of Suicidal Ideation per CSSRS each day

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Daily rankings of Wish to be Dead, from the Thinking Diary, on a 0-10 scale. [This was the outcome used in the previous actigraphy study].

Measure: INPATIENT: Wish to be Dead

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Maximum Level of Suicidal Ideation per CSSRS 5 Level scale (ranging from Wish to be Dead to Active Ideation with Intent and Plan) combined with the items/scores in the 2nd half of the suicidal ideation assessment (frequency, controllability). Investigators will use chart and interview information for patients who can be reached by phone and interview information for those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls). Exact procedure for combining (e.g. simple addition) to be determined, possibly in consultation with Columbia scale staff.

Measure: INPATIENT: Combination of Maximum Level of Suicidal Ideation per CSSRS each day plus Frequency, Controllability, etc. items

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: We have created our own 0-10 scale of the highest intensity of suicidal thinking a participant experienced in the 12 months post-discharge. This will be used for some of the secondary analyses of outcomes 12 months after discharge. While it is not validated, it has the advantage that, as opposed to any Yes/No events (rehospitalization, experiencing of a certain severity of suicidal thinking), that every study participant will have a value on this particular scale.

Measure: Maximum severity of suicidal ideation in 12 months post-discharge (self-report, 0-10 scale)

Time: 12 months post-discharge

Other Outcomes

Description: The investigators will call patients and administer CSSRS to determine as well as determine events from the chart, both for patients who can be reached by phone and those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls).

Measure: POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors (without Rehospitalization)

Time: 12 months post Discharge

Description: The investigators will call patients and administer CSSRS to determine, and ask about rehospitalization with SI, as well as determine this information from the chart, both for patients who can be reached by phone and those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls).

Measure: POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation involves Plan and Intent

Time: 12 months post discharge

Description: The investigators will call patients and administer CSSRS to determine, and ask about rehospitalization with SI, as well as determine the occurrence of these outcomes from the chart, both for patients who can be reached by phone and those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls).

Measure: POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation includes Method, Intent, or Plan

Time: 12 months post discharge

Description: 11 items concerning psychiatric symptoms and movement/activity, on a 0-10 scale. Each will be examined individually.

Measure: INPATIENT: Nonsuicide Symptom Diary Items

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Association of the SIAT with Sheehan STS scale score for past 24 hours at baseline

Measure: INPATIENT:Sheehan STS score

Time: 24 hours before enrollment (baseline)

Description: The investigators will use Sheehan scale as an index, either: A) Weighting reach response on questions 2-6, and 8 with each question being worth 5X the previous question, and responses worth 0-4 points, depending on frequency (this will result in a scale from 0 - 4096), and/or B) a simple unweighted version which gives a score from 0 - 24 based on how frequently client endorses highest numbered item, based on specific thresholds ( a little, moderately, etc.) .

Measure: INPATIENT: Combination of Sheehan Measures

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: The investigators will examine the association of each Sheehan item, questions 2-6 and 8 with the actigraph and other predictors.

Measure: INPATIENT: Individual Sheehan Items

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Suicidal Ideation Item on CSSRS.

Measure: INPATIENT: CSSRS Duration Item

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Association of the SIAT with Level of Suicidal thinking (0-5) on Columbia Scale (CSSRS) at baseline (over last week for SI, last 2 weeks for SB)

Measure: INPATIENT: CSSRS at baseline

Time: 1-2 weeks pre-enrollment

Description: Suicidal Ideation Item on CSSRS.

Measure: INPATIENT: CSSRS Frequency Item

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Association of the SIAT with Duration of Suicidal Thinking (0-10) Today

Measure: INPATIENT: Duration of Suicidal Thinking

Time: 24 hours pre-enrollment

Description: The investigators will use some combination of the Frequency and Duration item (either simple addition or multiplication, or some other combination, taking into account as frequency increases the maximum duration must at some point decrease).

Measure: INPATIENT: CSSRS Frequency/Duration Item combination

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Association of the SIAT with PHQ-9 score Item 9 (Frequency for last 2 weeks, including better off dead) for last 2 weeks

Measure: INPATIENT: PHQ-9 score Item 9 (0-3)

Time: 2 weeks pre-enrollment (baseline)

Description: Suicidal Ideation Item on CSSRS.

Measure: INPATIENT: CSSRS Controllability Item

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Although this will be analyzed, it is not expected this will correlate as much with actigraphy or other predictors than other CSSRS items.

Measure: INPATIENT: CSSRS Deterrents Item

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Although this will be analyzed, it is not expected this will correlate as much with actigraphy or other predictors than other CSSRS items.

Measure: INPATIENT: CSSRS Reasons Item

Time: Duration of Inpatient Stay (Daily Measures, up to 365 days)

Description: Suicidal behavior, only counting behaviors of a certain level of lethality.

Measure: POST-DISCHARGE FOLLOW-UP: Actual Suicidal Behavior with Lethality of 1+ on CSSRS

Time: 12 months post-discharge

Description: Association of the SIAT with Sheehan STS scale score for past 24 hours at baseline.

Measure: INPATIENT:Sheehan Tracking System

Time: 24 hours pre-enrollment (baseline)

Description: For analyses examining CHANGE in the Actigraph index, or CHANGE in the Actigraph index plus change in some of the other predictors, the investigators will examine an outcome involving Change in Suicidal Thinking (probably the measure most predictive in the earlier analyses of the level of the index/predictors and the severity/duration of suicidal thinking).

Measure: INPATIENT: Change in Severity or Duration of Suicidal Thinking or the Composite Measure

Time: Inpatient (Daily Measures, Days 1 and 2 combined versus last 1, 2, or 3 days [longest period up to 3 days that does not overlap with days 1&2)

Description: Suicidal behavior, only counting behaviors of a certain level of lethality.

Measure: POST-DISCHARGE FOLLOW-UP: Actual Suicidal Behavior with Lethality 2+ on CSSRS

Time: 12 months (post-discharge

Description: Association of the Sheehan STS scale score for the 24 hours prior to enrollment (baseline) with the Actigraph movement index (called to this point the Vulnerability Index, but we may invert and call it the Resiliency index), for days 1-3 of the study.

Measure: INPATIENT: Sheehan Tracking System

Time: 24 hours pre-enrollment (baseline)

Description: Association of the Sheehan STS scale score for the 24 hours prior to enrollment (baseline) with a modified (shorter time-frame) version of the Actigraph movement index (called to this point the Vulnerability Index, but we may invert the index and call the Resiliency Index), for day 1 of the study, day 1 and 2 of the study combined, or both.

Measure: INPATIENT: Sheehan Tracking System

Time: 24 hours pre-enrollment (baseline)

Description: Association of the Level of Suicidal thinking (0-5) on Columbia Scale (CSSRS) at baseline (over last week for SI, last 2 weeks for SB) with the Actigraph movement index (called to this point the Vulnerability Index, but we may invert the index and call it the Resliency index), for days 1-3 of the study.

Measure: INPATIENT: CSSRS at baseline

Time: 1-2 weeks prior to enrollment (baseline)

Description: Association of the Level of Suicidal thinking (0-5) on Columbia Scale (CSSRS) at baseline (over last week for SI, last 2 weeks for SB) with a modified (shorter time-frame) version of the Actigraph movement index (called to this point the Vulnerability Index, but we may invert and call the Resiliency Index, for day 1 of the study, day 1 and 2 of the study combined, or both.

Measure: INPATIENT: CSSRS at baseline

Time: 1-2 weeks prior to enrollment (baseline)

Description: Association of the Duration of Suicidal Thinking (0-10) Today item of the Thinking Diary at baseline with the Actigraph movement index (called to this point the Vulnerability Index, but we may invert the index and call it the Resiliency index), for days 1-3 of the study.

Measure: INPATIENT: Duration of Suicidal Thinking

Time: Day of enrollment but for the hours prior to enrollment (baseline)

Description: Association of the Duration of Suicidal Thinking (0-10) Today item of the Thinking Diary at baseline with a modified (shorter time-frame) version of the Actigraph movement index (called to this point the Vulnerability Index, but we may invert and call the Resiliency Index, for day 1 of the study, day 1 and 2 of the study combined, or both.

Measure: INPATIENT: Duration of Suicidal Thinking

Time: Day of enrollment but for the hours prior to enrollment (baseline)

Description: Association of the PHQ-9 score for Item 9 (Frequency over the last 2 weeks of thoughts of self-harm, or thoughts would be better off dead) with the Actigraph movement index (called to this point the Vulnerability Index, but we may invert the index and call it the Resiliency index), for days 1-3 of the study.

Measure: INPATIENT: PHQ-9 Item 9 Score (0-3)

Time: 2 weeks prior to enrollment (baseline)

Description: Association of the PHQ-9 score for Item 9 (Frequency over the last 2 weeks of thoughts of self-harm, or thoughts would be better off dead) with a modified (shorter time-frame) version of the Actigraph movement index (called to this point the Vulnerability Index, but we may invert and call the Resiliency Index, for day 1 of the study, day 1 and 2 of the study combined, or both.

Measure: INPATIENT: PHQ-9 Item 9 Score (0-3)

Time: 2 weeks prior to enrollment (baseline)

Description: We will derive the Pearson correlation coefficient between the S-IAT d score at Baseline and their reported Wish to be Dead that day at baseline (ie., not considering any data from the subsequent hospitalization). This is being performed as pilot analysis to support a grant application.

Measure: Wish to be Dead (0-10) scale at baseline

Time: Baseline (that day)

Description: We will derive the Pearson correlation coefficient between the Actigraphy Vulnerability Index (also known as the Resiliency Index if the scores are inverted) their reported Wish to be Dead that day at baseline (ie., not considering any data from the subsequent hospitalization). This is being performed as pilot analysis to support a grant application.

Measure: Wish to be Dead (0-10) scale at baseline

Time: Baseline (that day)


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