Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS

May 12, 2017 updated by: VA Eastern Colorado Health Care System
The purpose of this project is to gather pilot data related to exploring relationships between cognitive impairment and/or psychiatric distress and suicidal thoughts and/or behaviors in Veterans with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS). To achieve this goal, a neuropsychological battery will be administered to Veterans with HIV/AIDS.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Eastern Colorado Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Veterans with HIV/AIDS

Description

Inclusion Criteria:

  • Veterans between ages 18 to 65
  • Have a diagnosis of HIV/AIDS confirmed via medical record
  • Currently receiving or eligible to receive physical and/or mental health care through the VA Eastern Colorado Health Care System

Exclusion Criteria:

  • Acute intoxication via alcohol or other illicit drugs at time of assessment as determined by observation and/or interview.
  • Psychosis at time of interview as determined by observation and/or interview.
  • Poor Test of Memory Malingering (TOMM) performance (scores below 25 on Trial 1 or scores lower than 45 on Trial 2)
  • Current status as a prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Veterans with HIV/AIDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV)
Time Frame: 1 Time Administration
The WAIS-IV is a widely used and well established instrument used to assesses an individual's intellectual functioning within various cognitive domains and organizes performance into several indices including Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, and Processing Speed Index. A composite, Full Scale IQ, is also generated to represent an estimation of overall intellectual functioning.
1 Time Administration
Trail Making Test (TMT): Parts A & B
Time Frame: 1 Time Administration
The TMT is a timed, pencil-paper, measure of attention, speed, and cognitive flexibility and requires participants to draw a line to accurately sequence 25 circles containing numbers (Part A) and alternating letters and numbers (Part B).
1 Time Administration
California Verbal Learning Test, Second Edition (CVLT-II)
Time Frame: 1 Time Adminstration
The CVLT-II examines several aspects of verbal learning, organization, and memory.
1 Time Adminstration
Delis-Kaplan Executive Function System (D-KEFS)
Time Frame: 1 Time Administration
Measure of executive functioning.
1 Time Administration
Brief VisuoSpatial Memory Test-Revised (BVMT-R)
Time Frame: 1 Time Administration
The BVMT-R measures immediate and delayed visual memory.
1 Time Administration
Wisconsin Card Sorting Test (WCST)
Time Frame: 1 Time Administration
Measure of executive functioning.
1 Time Administration
Outcome Questionnaire (OQ-45)
Time Frame: 1 Time Administration
The OQ-45 is a 45-item questionnaire that was designed to measure key areas of mental health functioning (symptom distress, interpersonal functioning, and social role).
1 Time Administration
Beck Scale for Suicide Ideation (BSS)
Time Frame: 1 Time Administration
The BSS is a 19-item scale that assesses severity of suicide ideation.
1 Time Administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Status Questionnaire (HSQ)
Time Frame: 1 Time Administration
The HSQ is a 39-item, multiple choice, self-report measure that collects patient-reported, subjective data on eight subscales: Health Perception, Physical Functioning, Role Limitations/Physical Health, Role Limitations/Emotional Problems, Social Functioning, Mental Health, Bodily Pain and Energy/Fatigue.
1 Time Administration
University of Washington Risk Assessment Protocol-Revised (UWRAP)
Time Frame: 1 Time Administration
The UWRAP will be used to address potential risk associated with participating in the study.
1 Time Administration
Test of Memory Malingering (TOMM)
Time Frame: 1 Time Administration
The TOMM is a measure of effortful performance on objective tasks.
1 Time Administration
The Structured Clinical Interview for DSM-IV-Research Version (SCID-I)
Time Frame: 1 Time Administration
The SCID is a reliable and valid semi-structured interview used to make psychiatric diagnosis in both clinical and research settings.
1 Time Administration
Lifetime Suicide Attempt Self Injury Interview (L-SASI)
Time Frame: 1 Time Administration
The L-SASI was developed as a very brief survey of lifetime intentional self-harm behaviors and categorizes them into suicide attempts and non-suicidal acts.
1 Time Administration
Participant Demographics Form
Time Frame: 1 Time Administration
A questionnaire was created by members of the research team to collect data regarding demographics.
1 Time Administration
Ohio State University TBI-ID (OSU TBI-ID) Short Form
Time Frame: 1 Time Administration
The OSU TBI-ID Short Form will be used to determine history of TBI and presence of persistent TBI-related complaints.
1 Time Administration
Beck Hopelessness Scale (BHS)
Time Frame: 1 Time Administration
The BHS is a 20-item true-false self-report scale that measures the level of negative expectations about the future held by respondents.
1 Time Administration
The Beck Depression Inventory (BDI-II)
Time Frame: 1 Time Administration
The BDI-II is a widely used 21 item, self-administered instrument used to detect depression.
1 Time Administration
The Beck Anxiety Inventory (BAI)
Time Frame: 1 Time Administration
The BAI is a widely-used, 21-item, self-administered instrument used to measure the severity of an individual's anxiety.
1 Time Administration
Military Suicide Research Consortium (MSRC) Common Data Elements
Time Frame: 1 Time Administration
The Common Data Elements are a compilation of validated and reliable measures used to gather data on the risk factors for suicidal behavioral.
1 Time Administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Eastern Colorado Health Care System

Investigators

  • Principal Investigator: Gina Signoracci, Ph.D., VISN 19 Denver VA MIRECC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 13, 2012

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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