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Completed

NCT Number: NCT01749007

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Self-Injurious Behavior Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Suicide Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Colorado Health Care System

Denver, Colorado, 80220, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. Delis-Kaplan Executive Function System (D-KEFS)

    Time frame: 1 Time Administration

    Measure of executive functioning.

  5. Brief VisuoSpatial Memory Test-Revised (BVMT-R)

    Time frame: 1 Time Administration

    The BVMT-R measures immediate and delayed visual memory.

  6. Wisconsin Card Sorting Test (WCST)

    Time frame: 1 Time Administration

    Measure of executive functioning.

  7. 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).

  8. Beck Scale for Suicide Ideation (BSS)

    Time frame: 1 Time Administration

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

Secondary outcomes

  1. 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.

  2. 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.

  3. Test of Memory Malingering (TOMM)

    Time frame: 1 Time Administration

    The TOMM is a measure of effortful performance on objective tasks.

  4. 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.

  5. 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.

  6. Participant Demographics Form

    Time frame: 1 Time Administration

    A questionnaire was created by members of the research team to collect data regarding demographics.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

VA Eastern Colorado Health Care System

Fed

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Dec 13, 2012
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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