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



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:February 21, 2017
End Date:August 30, 2021
Contact:Eric G Smith, MD PhD MPH
Email:eric.smith5@va.gov
Phone:(781) 687-2766

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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.

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.

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
We found this trial at
1
site
Bedford, Massachusetts 01730
Principal Investigator: Eric G. Smith, MD PhD MPH
Phone: 781-687-2766
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Bedford, MA
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