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

NCT ID: NCT03080168

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2021-04-01

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.

Conditions

Suicidal Ideation; Suicidal Behavior; Mental Health Symptoms; Mental Health Hospitalizations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Actigraph

All participants will wear an Actigraph (monitoring device) for the duration of their inpatient stay.

NOTE: In clarification, for both this section and Section 4, this devices is an FDA-regulated monitoring device, but NOT an Intervention in this study.

Actigraph

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric G. Smith, MD PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Locations

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1I01CX001424-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MHBA-017-15S

Identifier Type: -

Identifier Source: org_study_id