Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS
This study is currently recruiting participants.
Verified December 2012 by VA Eastern Colorado Health Care System
Sponsor:
VA Eastern Colorado Health Care System
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
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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
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 May 16, 2013