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Clinical Trials/NCT01749007
NCT01749007
Completed
N/A

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

VA Eastern Colorado Health Care System1 site in 1 country50 target enrollmentNovember 2012
ConditionsHIV/AIDS

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
VA Eastern Colorado Health Care System
Enrollment
50
Locations
1
Primary Endpoint
Outcome Questionnaire (OQ-45)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
January 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

Delis-Kaplan Executive Function System (D-KEFS)

Time Frame: 1 Time Administration

Measure of executive functioning.

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).

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.

Brief VisuoSpatial Memory Test-Revised (BVMT-R)

Time Frame: 1 Time Administration

The BVMT-R measures immediate and delayed visual memory.

Wisconsin Card Sorting Test (WCST)

Time Frame: 1 Time Administration

Measure of executive functioning.

Beck Scale for Suicide Ideation (BSS)

Time Frame: 1 Time Administration

The BSS is a 19-item scale that assesses severity of suicide ideation.

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.

Secondary Outcomes

  • Health Status Questionnaire (HSQ)(1 Time Administration)
  • Participant Demographics Form(1 Time Administration)
  • Military Suicide Research Consortium (MSRC) Common Data Elements(1 Time Administration)
  • Test of Memory Malingering (TOMM)(1 Time Administration)
  • Ohio State University TBI-ID (OSU TBI-ID) Short Form(1 Time Administration)
  • The Beck Anxiety Inventory (BAI)(1 Time Administration)
  • University of Washington Risk Assessment Protocol-Revised (UWRAP)(1 Time Administration)
  • The Structured Clinical Interview for DSM-IV-Research Version (SCID-I)(1 Time Administration)
  • Lifetime Suicide Attempt Self Injury Interview (L-SASI)(1 Time Administration)
  • Beck Hopelessness Scale (BHS)(1 Time Administration)
  • The Beck Depression Inventory (BDI-II)(1 Time Administration)

Study Sites (1)

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