The "AIM Study": Investigating Whether Actigraphy and Ideation Measures Can Promote Patient Safety

Suicidal Ideation Clinical Trial

— AIM  

Official title:

Assessing Actigraphy-Determined Movement Variability as a Novel Objective Marker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080168
• Other study ID #: MHBA-017-15S
• Secondary ID: 1I01CX001424-01
• Status: Completed
• Start date: February 21, 2017
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

As a consequence of the COVID-19 pandemic, and after consultation with the appropriate research oversight, regulatory and monitoring entities, screening and enrollment was been placed on temporary administrative hold as of 3 17 2020. As the pandemic has continued, we have reviewed our data and decided to close the study to enrollment and proceed to our analyses of findings.

RESEARCH DESIGN: A prospective cohort study of Veterans will be conducted to determine if the previously-identified specific actigraphy-based measurements highly associated with suicidal ideation in non-Veterans will predict suicidal ideation, suicidal behavior, and/or rehospitalization in Veterans.

METHODS: An analysis of Veterans admitted to the Bedford, Massachusetts VAMC acute psychiatry unit will be conducted. The primary analysis will focus upon Veterans with current suicidal ideation or recent suicidal behavior (SI/SB) who do not have a primary psychotic disorder, Alzheimer's, or Parkinson's disease, and who are not undergoing alcohol detoxification. A separate analysis will be conducted of patients undergoing alcohol detoxification, half with SI/SB and half without SI/SB. Participants will wear a small, unobtrusive, wristwatch-like actigraph on their nondominant wrist, and complete self-rated and clinician-rated assessments of suicidal ideation, as well as self-rated assessments of the severity of other psychiatric symptoms. A Resiliency Index (RI) will be calculated using nonlinear dynamic analysis of the amplitude of movements over time frames from 6 minutes - 2 hours. These time frames are the periods for which a clear structure to the movement data is evident, with patients with suicidal ideation showing less variation in amplitude than patients without suicidal ideation. If medications given for alcohol detoxification are determined to not interfere with the RI, then a secondary analysis will examine the entire sample of Veterans. One Aim will focus upon determining whether the original Resiliency Index or alternative movement data indices, such as one based on the change in the movement data over the hospitalization, predicts the presence and severity of suicidal ideation among Veteran inpatients. This aim will also examine the sensitivity and specificity of the RI for detecting the presence of any suicidal ideation, and of substantial suicidal ideation. (In non-Veterans, the RI showed a sensitivity of 72% and a specificity of 100% for detecting any suicidal ideation, and 86% and 88%, respectively, for detecting substantial ideation). In addition, the investigators may determine whether the RI predicts subsequent suicidal behavior or rehospitalization over different time periods within the original 12 month followup period, alone or combined with data about symptom severity, past history, and the present hospitalization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age 18 years or older and endorsing either suicidal ideation upon admission or within the last 7 days, or endorsing (or otherwise documented) suicidal behavior within the past 14 days before admission; OR

2. age 18 years or older and undergoing alcohol detoxification (including patients who qualify under #1 and are undergoing alcohol detoxification).

Exclusion Criteria:

• presence of a primary psychotic disorder [schizophrenia, schizoaffective disorder, psychosis not otherwise specified, and other psychoses] diagnosis on admission; or major depressive disorder with psychosis, or current hallucinations or ideas of reference, endorsing current psychotic thinking on the Psychosis Screen measure

• presence of a flag specifying a history of disruptive or violent behavior, or, if found during review of elements of the patient's chart prior to study enrollment, indication of a history of violent behavior towards staff, caregivers, or other patients in the patient's record, or if discussion with hospital staff indicates the potential participant's mental status is unstable enough or hostile enough to raise concerns about assaultive behavior

• Prisoner (of federal, state, or local authorities)

• Currently admitted to 78G under an involuntary commitment (e.g., "Section 12"). Specifically, no patients will be enrolled as participants who were committed to the inpatient unit involuntarily who has not chosen voluntarily to change their status to that of a voluntarily admitted patient (ie., signed a "Conditional Voluntary" form)

• Interviewer or Hospital staff-suspected or chart-documented presence of mental retardation (IQ <70) or other DSM-IV organic mental disorder (e.g., including Alzheimer's dementia)

• acute alcohol or drug intoxication or any delirium

• receiving alcohol detoxification treatment [for Primary Analysis]

• women who are pregnant

• patients undergoing detoxification for opiates

Related Conditions & MeSH terms

• Mental Health Hospitalizations
• Mental Health Symptoms
• Suicidal Behavior
• Suicidal Ideation

Intervention

Device:
• Actigraph
This is NOT an intervention but a monitoring device. All participants will wear an Actigraph for the duration of their inpatient stay, as well as complete paper and computer assessments.

Locations

Country	Name	City	State
United States	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors (without Rehospitalization)	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).	12 months post Discharge
Other	POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation involves Plan and Intent	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).	12 months post discharge
Other	POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation includes Method, Intent, or Plan	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).	12 months post discharge
Other	INPATIENT: Nonsuicide Symptom Diary Items	11 items concerning psychiatric symptoms and movement/activity, on a 0-10 scale. Each will be examined individually.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Other	INPATIENT:Sheehan STS score	Association of the SIAT with Sheehan STS scale score for past 24 hours at baseline	24 hours before enrollment (baseline)
Other	INPATIENT: Combination of Sheehan Measures	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.) .	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Other	INPATIENT: Individual Sheehan Items	The investigators will examine the association of each Sheehan item, questions 2-6 and 8 with the actigraph and other predictors.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Other	INPATIENT: CSSRS Duration Item	Suicidal Ideation Item on CSSRS.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Other	INPATIENT: CSSRS at baseline	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)	1-2 weeks pre-enrollment
Other	INPATIENT: CSSRS Frequency Item	Suicidal Ideation Item on CSSRS.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Other	INPATIENT: Duration of Suicidal Thinking	Association of the SIAT with Duration of Suicidal Thinking (0-10) Today	24 hours pre-enrollment
Other	INPATIENT: CSSRS Frequency/Duration Item combination	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).	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Other	INPATIENT: PHQ-9 score Item 9 (0-3)	Association of the SIAT with PHQ-9 score Item 9 (Frequency for last 2 weeks, including better off dead) for last 2 weeks	2 weeks pre-enrollment (baseline)
Other	INPATIENT: CSSRS Controllability Item	Suicidal Ideation Item on CSSRS.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Other	INPATIENT: CSSRS Deterrents Item	Although this will be analyzed, it is not expected this will correlate as much with actigraphy or other predictors than other CSSRS items.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Other	INPATIENT: CSSRS Reasons Item	Although this will be analyzed, it is not expected this will correlate as much with actigraphy or other predictors than other CSSRS items.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Other	POST-DISCHARGE FOLLOW-UP: Actual Suicidal Behavior with Lethality of 1+ on CSSRS	Suicidal behavior, only counting behaviors of a certain level of lethality.	12 months post-discharge
Other	INPATIENT:Sheehan Tracking System	Association of the SIAT with Sheehan STS scale score for past 24 hours at baseline.	24 hours pre-enrollment (baseline)
Other	INPATIENT: Change in Severity or Duration of Suicidal Thinking or the Composite Measure	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).	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)
Other	POST-DISCHARGE FOLLOW-UP: Actual Suicidal Behavior with Lethality 2+ on CSSRS	Suicidal behavior, only counting behaviors of a certain level of lethality.	12 months (post-discharge
Other	INPATIENT: Sheehan Tracking System	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.	24 hours pre-enrollment (baseline)
Other	INPATIENT: Sheehan Tracking System	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.	24 hours pre-enrollment (baseline)
Other	INPATIENT: CSSRS at baseline	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.	1-2 weeks prior to enrollment (baseline)
Other	INPATIENT: CSSRS at baseline	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.	1-2 weeks prior to enrollment (baseline)
Other	INPATIENT: Duration of Suicidal Thinking	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.	Day of enrollment but for the hours prior to enrollment (baseline)
Other	INPATIENT: Duration of Suicidal Thinking	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.	Day of enrollment but for the hours prior to enrollment (baseline)
Other	INPATIENT: PHQ-9 Item 9 Score (0-3)	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.	2 weeks prior to enrollment (baseline)
Other	INPATIENT: PHQ-9 Item 9 Score (0-3)	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.	2 weeks prior to enrollment (baseline)
Other	Wish to be Dead (0-10) scale at baseline	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.	Baseline (that day)
Other	Wish to be Dead (0-10) scale at baseline	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.	Baseline (that day)
Primary	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	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.	12 months since discharge from index hospitalization
Primary	INPATIENT: Sheehan STS scale	Association of Actigraph measurements with Sheehan STS Scale	Last 24 hours up to assessment
Secondary	INPATIENT: Self-report response to Suicidal thinking diary questions re Combined Severity and Duration of suicidal thinking [Main Secondary Analysis]	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.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Secondary	POST DISCHARGE FOLLOW-UP: Actual Suicidal Behavior (self-report and chart informed) [Main Secondary]	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).	12 months (12 months since discharge from index hospitalization)
Secondary	POST-DISCHARGE FOLLOW-UP: All Suicidal Behavior plus Rehospitalization plus Severity of Worst Suicidal Ideation (Some Intent or Some Intent or Plan) [Main Secondary]	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).	12 months since Discharge
Secondary	INPATIENT: Severity of Suicidal Ideation	Daily rankings of Severity of Suicidal Ideation, from the Suicidal Thinking Diary, on a scale of 0-10.	Duration of Inpatient Stay (Daily Measures, up to 365 days [It is anticipated most subjects will provide from 2-7 days of data)
Secondary	INPATIENT: Duration of Suicidal Ideation (Thinking Diary)	Daily rankings of Duration of Suicidal Ideation, from the Suicidal Thinking Diary, on a scale of 0-10.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Secondary	INPATIENT: Duration of Suicidal Ideation (Hours/minutes)	Daily rankings of Duration of Suicidal Ideation, from the Sheehan Tracking Scale, in hours and minutes.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Secondary	INPATIENT: Maximum Level of Suicidal Ideation per CSSRS each day	Maximum Level of Suicidal Ideation per CSSRS 5 Level scale (ranging from Wish to be Dead to Active Ideation with Intent and Plan).	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Secondary	INPATIENT: Wish to be Dead	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].	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Secondary	INPATIENT: Combination of Maximum Level of Suicidal Ideation per CSSRS each day plus Frequency, Controllability, etc. items	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.	Duration of Inpatient Stay (Daily Measures, up to 365 days)
Secondary	Maximum severity of suicidal ideation in 12 months post-discharge (self-report, 0-10 scale)	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.	12 months post-discharge