HIV/AIDSNCT01749007
Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS
An observational study of HIV/AIDS, run by VA Eastern Colorado Health Care System at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans with HIV/AIDS
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Colorado Health Care System
Denver, Colorado, 80220
About this study
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.
- Conditions
- HIV/AIDS
- Keywords
- Veterans, HIV, AIDS, Cognitive Functioning, Suicide
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with HIV/AIDS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Time Administration
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).
Measured: 1 Time Administration
California Verbal Learning Test, Second Edition (CVLT-II)
The CVLT-II examines several aspects of verbal learning, organization, and memory.
Measured: 1 Time Adminstration
Delis-Kaplan Executive Function System (D-KEFS)
Measure of executive functioning.
Measured: 1 Time Administration
Brief VisuoSpatial Memory Test-Revised (BVMT-R)
The BVMT-R measures immediate and delayed visual memory.
Measured: 1 Time Administration
Wisconsin Card Sorting Test (WCST)
Measure of executive functioning.
Measured: 1 Time Administration
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).
Measured: 1 Time Administration
Beck Scale for Suicide Ideation (BSS)
The BSS is a 19-item scale that assesses severity of suicide ideation.
Measured: 1 Time Administration
Secondary outcomes (11)
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.
Measured: 1 Time Administration
University of Washington Risk Assessment Protocol-Revised (UWRAP)
The UWRAP will be used to address potential risk associated with participating in the study.
Measured: 1 Time Administration
Test of Memory Malingering (TOMM)
The TOMM is a measure of effortful performance on objective tasks.
Measured: 1 Time Administration
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.
Measured: 1 Time Administration
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.
Measured: 1 Time Administration
Participant Demographics Form
A questionnaire was created by members of the research team to collect data regarding demographics.
Measured: 1 Time Administration
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.
Measured: 1 Time Administration
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.
Measured: 1 Time Administration
The Beck Depression Inventory (BDI-II)
The BDI-II is a widely used 21 item, self-administered instrument used to detect depression.
Measured: 1 Time Administration
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.
Measured: 1 Time Administration
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.
Measured: 1 Time Administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gina Signoracci, Ph.D., Principal investigator, VISN 19 Denver VA MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749007
- Sponsor's protocol ID
- 12-1039
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Functioning as it Relates to Risk for Suicide in Veterans With HIV/AIDS
- ClinicalTrials.gov ID
- NCT01749007
- Acronym / sponsor ID
- 12-1039
- Conditions
- HIV/AIDS
- Keywords
- Veterans, HIV, AIDS, Cognitive Functioning, Suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Nov 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans with HIV/AIDS | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with HIV/AIDS
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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.
Delis-Kaplan Executive Function System (D-KEFS)
Time frame: 1 Time Administration
Measure of executive functioning.
Brief VisuoSpatial Memory Test-Revised (BVMT-R)
Time frame: 1 Time Administration
The BVMT-R measures immediate and delayed visual memory.
Wisconsin Card Sorting Test (WCST)
Time frame: 1 Time Administration
Measure of executive functioning.
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).
Beck Scale for Suicide Ideation (BSS)
Time frame: 1 Time Administration
The BSS is a 19-item scale that assesses severity of suicide ideation.
11 secondary outcomes
Health Status Questionnaire (HSQ)
Time frame: 1 Time Administration
University of Washington Risk Assessment Protocol-Revised (UWRAP)
Time frame: 1 Time Administration
Test of Memory Malingering (TOMM)
Time frame: 1 Time Administration
The Structured Clinical Interview for DSM-IV-Research Version (SCID-I)
Time frame: 1 Time Administration
Lifetime Suicide Attempt Self Injury Interview (L-SASI)
Time frame: 1 Time Administration
Participant Demographics Form
Time frame: 1 Time Administration
Ohio State University TBI-ID (OSU TBI-ID) Short Form
Time frame: 1 Time Administration
Beck Hopelessness Scale (BHS)
Time frame: 1 Time Administration
The Beck Depression Inventory (BDI-II)
Time frame: 1 Time Administration
The Beck Anxiety Inventory (BAI)
Time frame: 1 Time Administration
Military Suicide Research Consortium (MSRC) Common Data Elements
Time frame: 1 Time Administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Related trials for HIV/AIDS
RecruitingPhase 2
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
HIV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Not yet recruiting
Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach
Hiv
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe
HIV (Human Immunodeficiency Virus), HPV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Signoracci, Ph.D. principal investigator
VISN 19 Denver VA MIRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) (time frame: 1 Time Administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.