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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749007
• Other study ID #: 12-1039
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: May 12, 2017
• Start date: November 2012
• Est. completion date: January 2017

Study information

• Verified date: December 2012
• Source: VA Eastern Colorado Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS
• Suicide

Locations

Country	Name	City	State
United States	Eastern Colorado Health Care System	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV)	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
Primary	Trail Making Test (TMT): Parts A & B	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
Primary	California Verbal Learning Test, Second Edition (CVLT-II)	The CVLT-II examines several aspects of verbal learning, organization, and memory.	1 Time Adminstration
Primary	Delis-Kaplan Executive Function System (D-KEFS)	Measure of executive functioning.	1 Time Administration
Primary	Brief VisuoSpatial Memory Test-Revised (BVMT-R)	The BVMT-R measures immediate and delayed visual memory.	1 Time Administration
Primary	Wisconsin Card Sorting Test (WCST)	Measure of executive functioning.	1 Time Administration
Primary	Outcome Questionnaire (OQ-45)	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
Primary	Beck Scale for Suicide Ideation (BSS)	The BSS is a 19-item scale that assesses severity of suicide ideation.	1 Time Administration
Secondary	Health Status Questionnaire (HSQ)	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
Secondary	University of Washington Risk Assessment Protocol-Revised (UWRAP)	The UWRAP will be used to address potential risk associated with participating in the study.	1 Time Administration
Secondary	Test of Memory Malingering (TOMM)	The TOMM is a measure of effortful performance on objective tasks.	1 Time Administration
Secondary	The Structured Clinical Interview for DSM-IV-Research Version (SCID-I)	The SCID is a reliable and valid semi-structured interview used to make psychiatric diagnosis in both clinical and research settings.	1 Time Administration
Secondary	Lifetime Suicide Attempt Self Injury Interview (L-SASI)	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
Secondary	Participant Demographics Form	A questionnaire was created by members of the research team to collect data regarding demographics.	1 Time Administration
Secondary	Ohio State University TBI-ID (OSU TBI-ID) Short Form	The OSU TBI-ID Short Form will be used to determine history of TBI and presence of persistent TBI-related complaints.	1 Time Administration
Secondary	Beck Hopelessness Scale (BHS)	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
Secondary	The Beck Depression Inventory (BDI-II)	The BDI-II is a widely used 21 item, self-administered instrument used to detect depression.	1 Time Administration
Secondary	The Beck Anxiety Inventory (BAI)	The BAI is a widely-used, 21-item, self-administered instrument used to measure the severity of an individual's anxiety.	1 Time Administration
Secondary	Military Suicide Research Consortium (MSRC) Common Data Elements	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