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

Completed

• Conditions: HIV/AIDS

• Registration Number: NCT01749007
• Lead Sponsor: VA Eastern Colorado Health Care System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-13
• Primary Completion: 2016-08
• Study Completion: 2017-01
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome Questionnaire (OQ-45)	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)	1 Time Administration	Measure of executive functioning.
Trail Making Test (TMT): Parts A & B	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)	1 Time Adminstration	The CVLT-II examines several aspects of verbal learning, organization, and memory.
Brief VisuoSpatial Memory Test-Revised (BVMT-R)	1 Time Administration	The BVMT-R measures immediate and delayed visual memory.
Wisconsin Card Sorting Test (WCST)	1 Time Administration	Measure of executive functioning.
Beck Scale for Suicide Ideation (BSS)	1 Time Administration	The BSS is a 19-item scale that assesses severity of suicide ideation.
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV)	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 Outcome Measures

Name	Time	Method
Participant Demographics Form	1 Time Administration	A questionnaire was created by members of the research team to collect data regarding demographics.
Health Status Questionnaire (HSQ)	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.
Military Suicide Research Consortium (MSRC) Common Data Elements	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.
Test of Memory Malingering (TOMM)	1 Time Administration	The TOMM is a measure of effortful performance on objective tasks.
Ohio State University TBI-ID (OSU TBI-ID) Short Form	1 Time Administration	The OSU TBI-ID Short Form will be used to determine history of TBI and presence of persistent TBI-related complaints.
The Beck Anxiety Inventory (BAI)	1 Time Administration	The BAI is a widely-used, 21-item, self-administered instrument used to measure the severity of an individual's anxiety.
The Structured Clinical Interview for DSM-IV-Research Version (SCID-I)	1 Time Administration	The SCID is a reliable and valid semi-structured interview used to make psychiatric diagnosis in both clinical and research settings.
Lifetime Suicide Attempt Self Injury Interview (L-SASI)	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.
University of Washington Risk Assessment Protocol-Revised (UWRAP)	1 Time Administration	The UWRAP will be used to address potential risk associated with participating in the study.
Beck Hopelessness Scale (BHS)	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.
The Beck Depression Inventory (BDI-II)	1 Time Administration	The BDI-II is a widely used 21 item, self-administered instrument used to detect depression.

Trial Locations

Locations (1)

Eastern Colorado Health Care System; 🇺🇸 Denver, Colorado, United States