Posttraumatic Stress DisorderNCT01502436
An Exploration of the Relationship Between Chronic Pain and Suicide Attempt Among Veterans
An observational study of Posttraumatic Stress Disorder and Traumatic Brain Injury, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The purpose of this study is to explore the relationship between attempted and/or completed suicide and reported experience of chronic pain among an adult veteran population. Specific aims include a) examining the experience of chronic pain between patients who have either attempted and/or completed suicide… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Traumatic Brain Injury, Suicide Attempt
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Nov 2014
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans who received care in the VA.
Who may be able to join
- Over the age of 18
- Record of a suicide attempt or completion between October 2004 and February 2006
Who cannot join
- For cases: upon chart review, no record of a suicide attempt or completion within the specified time frame
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Colorado Healthcare System
Denver, Colorado, 80220
About this study
The purpose of this study is to explore the relationship between attempted and/or completed suicide and reported experience of chronic pain among an adult veteran population. Specific aims include a) examining the experience of chronic pain between patients who have either attempted and/or completed suicide, non-suicide attempt mental health patients, and non-mental health chronic pain patients and b) determining possible differences in reported experiences of chronic pain based on mental and physical diagnoses, age, gender, ethnicity, occupation, and patient's recorded perceptions of depression and/or quality of life. As articulated in the Amendment approved on June 13, 2008, additional areas of interest include histories of neurological disease (e.g. traumatic brain injury) and/or mental health diagnoses. History of both neurologic disease and mental health diagnoses will also be identified by chart review (per approval obtained June 13, 2008). As such this study will also compare differences (e.g., mental health, neurological disease) between veterans who have history of a suicide attempt, completion, or a lifetime history of suicidality and matched control veterans without a history of suicide attempts, completions, or lifetime history of suicide. The relationship between suicidal behavior, attempted/completed suicide, and reported Post Traumatic Stress Disorder (PTSD) symptoms among an adult veteran population is also of interest. Additionally, this data set will be used to complete a validation study regarding the Self-Directed Violence Classification System (SDVCS). Specifically, relevant information in subject chart notes regarding self-directed violence (SDV) will be used to categorize thoughts and behaviors according to the SDVCS.
- Keywords
- posttraumatic stress disorder, traumatic brain injury, Suicide Attempt, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic, Suicide, Attempted
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa Brenner, PhD, Principal investigator, VA VISN 19 MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502436
- Sponsor's protocol ID
- 06-0214
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2011
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of the Relationship Between Chronic Pain and Suicide Attempt Among Veterans
- ClinicalTrials.gov ID
- NCT01502436
- Acronym / sponsor ID
- 06-0214
- Keywords
- posttraumatic stress disorder, traumatic brain injury, Suicide Attempt, Veterans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Dec 2011 (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 study is to explore the relationship between attempted and/or completed suicide and reported experience of chronic pain among an adult veteran population. Specific aims include a) examining the experience of chronic pain between patients who have either attempted and/or completed suicide, non-suicide attempt mental health patients, and non-mental health chronic pain patients and b) determining possible differences in reported experiences of chronic pain based on mental and physical diagnoses, age, gender, ethnicity, occupation, and patient's recorded perceptions of depression and/or quality of life. As articulated in the Amendment approved on June 13, 2008, additional areas of interest include histories of neurological disease (e.g. traumatic brain injury) and/or mental health diagnoses. History of both neurologic disease and mental health diagnoses will also be identified by chart review (per approval obtained June 13, 2008). As such this study will also compare differences (e.g., mental health, neurological disease) between veterans who have history of a suicide attempt, completion, or a lifetime history of suicidality and matched control veterans without a history of suicide attempts, completions, or lifetime history of suicide. The relationship between suicidal behavior, attempted/completed suicide, and reported Post Traumatic Stress Disorder (PTSD) symptoms among an adult veteran population is also of interest. Additionally, this data set will be used to complete a validation study regarding the Self-Directed Violence Classification System (SDVCS). Specifically, relevant information in subject chart notes regarding self-directed violence (SDV) will be used to categorize thoughts and behaviors according to the SDVCS.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans who received care in the VA.
Key inclusion criteria (2 listed)
- Over the age of 18
- Record of a suicide attempt or completion between October 2004 and February 2006
Key exclusion criteria (1 listed)
- For cases: upon chart review, no record of a suicide attempt or completion within the specified time frame
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
Suicidal Ideation
Time frame: Baseline
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 28 Dec 2023.
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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.
Lisa Brenner, PhD principal investigator
VA VISN 19 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 Posttraumatic Stress Disorder and Traumatic Brain Injury, 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 2 inclusion and 1 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 28 Dec 2023. 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?
Suicidal Ideation (time frame: Baseline). 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 28 Dec 2023.