SuicideNCT01334385
Operation Enduring Freedom/Operation Iraqi Freedom Veterans' Experiences of Habituation to Pain, Perceived Burdensomeness, and Failed Belongingness
An observational study of Suicide, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
Veterans possess significant risk factors for self-directed violence (SDV). For example, depressed Veterans are at a greater risk for SDV than the general population. Although depressed male Veterans die by suicide at a higher rate than do their female counterparts (Zivin et al., 2007), female Operation Enduring… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Suicide
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2010
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Part I: Subjects were recruited from the population of over 250 OEF/OIF veterans with active cases in MHS within the Eastern Colorado Health Care System (ECHCS). Part II: Subjects were recruited from the population of over 250 OEF/OIF female veterans being cared for within the ECHCS.
Who may be able to join
- Part I:
- OEF/OIF returned veteran
- Age 18-55 years old
- Active case in mental health services
- Part II:
- OEF/OIF returned veteran
- Female
- Age 18-55 years old
Who cannot join
- Failure to correctly answer questions related to the informed consent process
- Active psychosis diagnosed by primary clinician
- Imminent suicidality
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Eastern Colorado Healthcare System
Denver, Colorado, 80220
About this study
Official title: OEF/OIF Veterans' Experiences of Habituation to Painful Stimuli, Perceived Burdensomeness and Failed Belongingness
Veterans possess significant risk factors for self-directed violence (SDV). For example, depressed Veterans are at a greater risk for SDV than the general population. Although depressed male Veterans die by suicide at a higher rate than do their female counterparts (Zivin et al., 2007), female Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans are at higher risk for depression than males (Seal et al., 2009). Joiner's (2005) theory states that suicidal individuals (a) perceive themselves to be unbearable burdens onto others; (b) view their efforts at establishing and maintaining social connections as having been thwarted or failed; and (c) have developed the ability to engage in SDV due to from increased habituation to pain. This two-part study uses semi-structured interviews in an effort to determine the extent to which Joiner's theory is applicable to OEF/OIF Veterans. Part I of this study, which has been completed, assessed the components of this theory among primarily male OEF/OIF Veterans. Part II of this study is assessing this theory's components among female OEF/OIF Veterans. Participants were recruited from the female OEF/OIF Veteran population receiving services through the Eastern Colorado Health Care System (ECHCS). Comparisons across the interview responses will be made to identify commonalities among the participants' experiences.
Read the detailed description
This is a qualitative, interview-based study designed to determine the extent to which three theoretical constructs - habituation to painful stimuli, perceived burdensomeness, and failed belongingness - are relevant to female veterans who have returned from OEF/OIF deployments. Joiner (2005) has proposed that the combination of those three factors is necessary and sufficient for an individual to engage in self-harm behaviors. Part I of this study, which explored Joiner's model among primarily male Veterans, is complete. Part II of the study will be a replication of Part I, but will instead be exploring Joiner's model in a female veteran population. The intention is to conduct a series of studies leading up to a full test of Joiner's model in a veteran population. OEF/OIF female veterans will be interviewed in an effort to determine how they understand these constructs and the language they use in discussing them.
Parts I and II of this study are necessary to determine that the key constructs are pertinent to veterans' experiences in general. It is also essential to identify the language they use when talking about these constructs. This information may be used in future studies to design veteran-specific measures. Using language which is meaningful to the population being studied increases the validity of a new measure and is considered good psychometric procedure (DeVellis, 2003; Haynes, Richard, \& Kubany, 1995). In addition, interviewing female veterans from the overall population of those receiving mental health services will increase the generalizability of future measures that are developed. Presuming Joiner's model is correct, participating in the interview may lead female veterans to spontaneously indicate that these factors could lead a person to think seriously about suicide. This possibility is despite the fact that the study will not be specifically targeting suicidal veterans or the fact that none of the questions ask about suicide or suicide-related behavior.
- Conditions
- Suicide
- Medical subject headings
- 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 |
|---|---|---|
| OEF/OIF Veterans through VA ECHCS | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMar 2007
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver, Portland State University, University of Missouri, Kansas City
- Investigators
- Lisa A Brenner, Ph.D., ABPP, Principal investigator, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334385
- Sponsor's protocol ID
- 06-1080
- Status last verified
- Apr 2011
- First submitted
- 11 Apr 2011
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OEF/OIF Veterans' Experiences of Habituation to Painful Stimuli, Perceived Burdensomeness and Failed Belongingness
- ClinicalTrials.gov ID
- NCT01334385
- Acronym / sponsor ID
- 06-1080
- Conditions
- Suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- University of Colorado, Denver, Portland State University, University of Missouri, Kansas City
- Study start
- Mar 2007
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Apr 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.
Veterans possess significant risk factors for self-directed violence (SDV). For example, depressed Veterans are at a greater risk for SDV than the general population. Although depressed male Veterans die by suicide at a higher rate than do their female counterparts (Zivin et al., 2007), female Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans are at higher risk for depression than males (Seal et al., 2009). Joiner's (2005) theory states that suicidal individuals (a) perceive themselves to be unbearable burdens onto others; (b) view their efforts at establishing and maintaining social connections as having been thwarted or failed; and (c) have developed the ability to engage in SDV due to from increased habituation to pain. This two-part study uses semi-structured interviews in an effort to determine the extent to which Joiner's theory is applicable to OEF/OIF Veterans. Part I of this study, which has been completed, assessed the components of this theory among primarily male OEF/OIF Veterans. Part II of this study is assessing this theory's components among female OEF/OIF Veterans. Participants were recruited from the female OEF/OIF Veteran population receiving services through the Eastern Colorado Health Care System (ECHCS). Comparisons across the interview responses will be made to identify commonalities among the participants' experiences.
Detailed description
This is a qualitative, interview-based study designed to determine the extent to which three theoretical constructs - habituation to painful stimuli, perceived burdensomeness, and failed belongingness - are relevant to female veterans who have returned from OEF/OIF deployments. Joiner (2005) has proposed that the combination of those three factors is necessary and sufficient for an individual to engage in self-harm behaviors. Part I of this study, which explored Joiner's model among primarily male Veterans, is complete. Part II of the study will be a replication of Part I, but will instead be exploring Joiner's model in a female veteran population. The intention is to conduct a series of studies leading up to a full test of Joiner's model in a veteran population. OEF/OIF female veterans will be interviewed in an effort to determine how they understand these constructs and the language they use in discussing them.
Parts I and II of this study are necessary to determine that the key constructs are pertinent to veterans' experiences in general. It is also essential to identify the language they use when talking about these constructs. This information may be used in future studies to design veteran-specific measures. Using language which is meaningful to the population being studied increases the validity of a new measure and is considered good psychometric procedure (DeVellis, 2003; Haynes, Richard, \& Kubany, 1995). In addition, interviewing female veterans from the overall population of those receiving mental health services will increase the generalizability of future measures that are developed. Presuming Joiner's model is correct, participating in the interview may lead female veterans to spontaneously indicate that these factors could lead a person to think seriously about suicide. This possibility is despite the fact that the study will not be specifically targeting suicidal veterans or the fact that none of the questions ask about suicide or suicide-related behavior.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OEF/OIF Veterans through VA ECHCS | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Part I: Subjects were recruited from the population of over 250 OEF/OIF veterans with active cases in MHS within the Eastern Colorado Health Care System (ECHCS). Part II: Subjects were recruited from the population of over 250 OEF/OIF female veterans being cared for within the ECHCS.
Key inclusion criteria (8 listed)
- OEF/OIF returned veteran
- Age 18-55 years old
- Active case in mental health services
- OEF/OIF returned veteran
- Female
Key exclusion criteria (3 listed)
- Failure to correctly answer questions related to the informed consent process
- Active psychosis diagnosed by primary clinician
- Imminent suicidality
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
Not reported in the source record.
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 13 Apr 2011.
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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 A Brenner, Ph.D., ABPP principal investigator
VA Eastern Colorado Health Care System
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 Suicide, 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 8 inclusion and 3 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 13 Apr 2011. 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.
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 13 Apr 2011.