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

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ClinicalTrials.gov Identifier: NCT01749007
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
HIV/AIDS

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS
Study Start Date : November 2012
Primary Completion Date : August 2016
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Suicide
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Veterans with HIV/AIDS


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Veterans with HIV/AIDS
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749007


Locations
United States, Colorado
Eastern Colorado Health Care System
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Investigators
Principal Investigator: Gina Signoracci, Ph.D. VISN 19 Denver VA MIRECC
More Information

Responsible Party: VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01749007     History of Changes
Other Study ID Numbers: 12-1039
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: December 2012

Keywords provided by VA Eastern Colorado Health Care System:
Veterans
HIV
AIDS
Cognitive Functioning
Suicide

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms