Trial record 5 of 28 for:    " December 05, 2012":" January 04, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by VA Eastern Colorado Health Care System
Sponsor:
Information provided by (Responsible Party):
VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01749007
First received: December 11, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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
Veterans With HIV/AIDS Diagnosis.

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS

Resource links provided by NLM:


Further study details as provided by VA Eastern Colorado Health Care System:

Primary Outcome Measures:
  • Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    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.

  • Trail Making Test (TMT): Parts A & B [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 Time Adminstration ] [ Designated as safety issue: No ]
    The CVLT-II examines several aspects of verbal learning, organization, and memory.

  • Delis-Kaplan Executive Function System (D-KEFS) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    Measure of executive functioning.

  • Brief VisuoSpatial Memory Test-Revised (BVMT-R) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    The BVMT-R measures immediate and delayed visual memory.

  • Wisconsin Card Sorting Test (WCST) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    Measure of executive functioning.

  • Outcome Questionnaire (OQ-45) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    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).

  • Beck Scale for Suicide Ideation (BSS) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: Yes ]
    The BSS is a 19-item scale that assesses severity of suicide ideation.


Secondary Outcome Measures:
  • Health Status Questionnaire (HSQ) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    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.

  • University of Washington Risk Assessment Protocol-Revised (UWRAP) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: Yes ]
    The UWRAP will be used to address potential risk associated with participating in the study.

  • Test of Memory Malingering (TOMM) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    The TOMM is a measure of effortful performance on objective tasks.

  • The Structured Clinical Interview for DSM-IV-Research Version (SCID-I) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    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.

  • Participant Demographics Form [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    A questionnaire was created by members of the research team to collect data regarding demographics.

  • Ohio State University TBI-ID (OSU TBI-ID) Short Form [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    The OSU TBI-ID Short Form will be used to determine history of TBI and presence of persistent TBI-related complaints.

  • Beck Hopelessness Scale (BHS) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: Yes ]
    The BDI-II is a widely used 21 item, self-administered instrument used to detect depression.

  • The Beck Anxiety Inventory (BAI) [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    The BAI is a widely-used, 21-item, self-administered instrument used to measure the severity of an individual's anxiety.

  • Military Suicide Research Consortium (MSRC) Common Data Elements [ Time Frame: 1 Time Administration ] [ Designated as safety issue: No ]
    The Common Data Elements are a compilation of validated and reliable measures used to gather data on the risk factors for suicidal behavioral.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Veterans with HIV/AIDS

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749007

Contacts
Contact: Gina Signoracci, Ph.D. 303-399-8020 ext 4653 Gina.Signoracci@va.gov

Locations
United States, Colorado
Eastern Colorado Health Care System Recruiting
Denver, Colorado, United States, 80220
Contact: Gina Signoracci, Ph.D.    303-399-8020 ext 4653    Gina.Signoracci@va.gov   
Principal Investigator: Gina Signoracci, Ph.D.         
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Investigators
Principal Investigator: Gina Signoracci, Ph.D. VISN 19 Denver VA MIRECC
  More Information

No publications provided

Responsible Party: VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01749007     History of Changes
Other Study ID Numbers: 12-1039
Study First Received: December 11, 2012
Last Updated: December 11, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Suicide
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014