Clinical trial NCT03080168: The "AIM Study": Investigating Whether Actigraphy and Ideation Measures Can Promote Patient Safety
Official title: Assessing Actigraphy-Determined Movement Variability as a Novel Objective Marker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicidal Ideation
Suicidal Behavior
Mental Health Symptoms
Mental Health Hospitalizations
Keywords: suicidal ideation
suicidal behavior
Veterans
inpatients
Actigraphy
implicit associations
risk factors
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-03-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US Veteran inpatients hospitalized for suicidal ideation, suicidal behavior, or alcohol detoxification

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 12 months since discharge from index hospitalization
measure: INPATIENT: Sheehan STS scale
timeFrame: Last 24 hours up to assessment
Secondary outcomes:
measure: INPATIENT: Self-report response to Suicidal thinking diary questions re Combined Severity and Duration of suicidal thinking [Main Secondary Analysis]
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: POST DISCHARGE FOLLOW-UP: Actual Suicidal Behavior (self-report and chart informed) [Main Secondary]
timeFrame: 12 months (12 months since discharge from index hospitalization)
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]
timeFrame: 12 months since Discharge
measure: INPATIENT: Severity of Suicidal Ideation
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days [It is anticipated most subjects will provide from 2-7 days of data)
measure: INPATIENT: Duration of Suicidal Ideation (Thinking Diary)
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: Duration of Suicidal Ideation (Hours/minutes)
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: Maximum Level of Suicidal Ideation per CSSRS each day
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: Wish to be Dead
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: Combination of Maximum Level of Suicidal Ideation per CSSRS each day plus Frequency, Controllability, etc. items
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: Maximum severity of suicidal ideation in 12 months post-discharge (self-report, 0-10 scale)
timeFrame: 12 months post-discharge
Other outcomes:
measure: POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors (without Rehospitalization)
timeFrame: 12 months post Discharge
measure: POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation involves Plan and Intent
timeFrame: 12 months post discharge
measure: POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation includes Method, Intent, or Plan
timeFrame: 12 months post discharge
measure: INPATIENT: Nonsuicide Symptom Diary Items
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT:Sheehan STS score
timeFrame: 24 hours before enrollment (baseline)
measure: INPATIENT: Combination of Sheehan Measures
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: Individual Sheehan Items
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: CSSRS Duration Item
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: CSSRS at baseline
timeFrame: 1-2 weeks pre-enrollment
measure: INPATIENT: CSSRS Frequency Item
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: Duration of Suicidal Thinking
timeFrame: 24 hours pre-enrollment
measure: INPATIENT: CSSRS Frequency/Duration Item combination
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: PHQ-9 score Item 9 (0-3)
timeFrame: 2 weeks pre-enrollment (baseline)
measure: INPATIENT: CSSRS Controllability Item
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: CSSRS Deterrents Item
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: INPATIENT: CSSRS Reasons Item
timeFrame: Duration of Inpatient Stay (Daily Measures, up to 365 days)
measure: POST-DISCHARGE FOLLOW-UP: Actual Suicidal Behavior with Lethality of 1+ on CSSRS
timeFrame: 12 months post-discharge
measure: INPATIENT:Sheehan Tracking System
timeFrame: 24 hours pre-enrollment (baseline)
measure: INPATIENT: Change in Severity or Duration of Suicidal Thinking or the Composite Measure
timeFrame: 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)
measure: POST-DISCHARGE FOLLOW-UP: Actual Suicidal Behavior with Lethality 2+ on CSSRS
timeFrame: 12 months (post-discharge
measure: INPATIENT: Sheehan Tracking System
timeFrame: 24 hours pre-enrollment (baseline)
measure: INPATIENT: Sheehan Tracking System
timeFrame: 24 hours pre-enrollment (baseline)
measure: INPATIENT: CSSRS at baseline
timeFrame: 1-2 weeks prior to enrollment (baseline)
measure: INPATIENT: CSSRS at baseline
timeFrame: 1-2 weeks prior to enrollment (baseline)
measure: INPATIENT: Duration of Suicidal Thinking
timeFrame: Day of enrollment but for the hours prior to enrollment (baseline)
measure: INPATIENT: Duration of Suicidal Thinking
timeFrame: Day of enrollment but for the hours prior to enrollment (baseline)
measure: INPATIENT: PHQ-9 Item 9 Score (0-3)
timeFrame: 2 weeks prior to enrollment (baseline)
measure: INPATIENT: PHQ-9 Item 9 Score (0-3)
timeFrame: 2 weeks prior to enrollment (baseline)
measure: Wish to be Dead (0-10) scale at baseline
timeFrame: Baseline (that day)
measure: Wish to be Dead (0-10) scale at baseline
timeFrame: Baseline (that day)
Locations:
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
state: Massachusetts
Study officials:
affiliation: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
name: Eric G. Smith, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: