Overview

This trial is active, not recruiting.

Condition veterans with hiv/aids diagnosis.
Sponsor VA Eastern Colorado Health Care System
Start date November 2012
End date September 2016
Trial size 50 participants
Trial identifier NCT01749007, 12-1039

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm

Primary Outcomes

Measure
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV)
time frame: 1 Time Administration
Trail Making Test (TMT): Parts A & B
time frame: 1 Time Administration
California Verbal Learning Test, Second Edition (CVLT-II)
time frame: 1 Time Adminstration
Delis-Kaplan Executive Function System (D-KEFS)
time frame: 1 Time Administration
Brief VisuoSpatial Memory Test-Revised (BVMT-R)
time frame: 1 Time Administration
Wisconsin Card Sorting Test (WCST)
time frame: 1 Time Administration
Outcome Questionnaire (OQ-45)
time frame: 1 Time Administration
Beck Scale for Suicide Ideation (BSS)
time frame: 1 Time Administration

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS
Principal investigator Gina Signoracci, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by VA Eastern Colorado Health Care System.