SuicideNCT01507675
Burden, Belonging, and Response to Pain in Veterans
An observational study of Suicide, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The primary purpose of the current study is to rigorously test the psychometric properties of the INQ-12 and ACSS (Van Orden et al., 2008) in Veterans, something which has not been done to date. Factor structure, internal consistency, convergent and discriminant validity will all be assessed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from all individuals eligible to receive care at the Denver VA Medical Center (DVAMC), regardless of clinic.
Who may be able to join
- Military veteran
- 18 or older
- Ability to respond to questions regarding the informed consent
Who cannot join
- Active-duty military
- Non-English speaking
- Inability to respond to questions regarding the informed consent procedure
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of the current study is to rigorously test the psychometric properties of the INQ-12 and ACSS (Van Orden et al., 2008) in Veterans, something which has not been done to date. Factor structure, internal consistency, convergent and discriminant validity will all be assessed. Secondary goals are to determine if burdensomeness, failed belongingness, and acquired capability are distinct versus overlapping constructs and whether or not values mediate the relationship between reasons for living and suicide risk. Lastly, the inclusion of the Beck Scale for Suicidal Ideation (BSS) allows us to analyze participants' responses to explore whether or not participants can be grouped into those who want to die by suicide because they want to escape their problems and those who want to die to influence other people.
Read the detailed description
Suicide is a significant problem among Veterans of the U.S. Military. Katz (2007) reported that there were 144 suicides among Veterans who served in Operation Enduring Freedom (OEF) and/or Operation Iraqi Freedom (OIF) from 2002-2005. There is no nationwide surveillance system that tracks Veteran suicides. However, the National Violent Death Reporting System (NVDRS) created in 2003 by the Centers for Disease Control and Prevention (CDC) with the purpose of gathering thorough information about suicides and other violent deaths allows researchers to reasonably extrapolate national suicide rates for Veterans. A CDC report (2006) based on NVDRS data estimated that approximately 6,500 veterans from all wars die by suicide each year, accounting for approximately 20% of suicides per year nationwide. While much is known about risk factors for suicide (e.g., Beck, Steer, Kovacs, \& Garrison, 1985; Jobes \& Mann, 1999) such information has little clinical utility for predicting whether or not an individual is likely to die by suicide in the near-term. One of the few attempts to address this issue is the interpersonal-psychological theory of suicide (Joiner, 2005). The interpersonal psychological theory proposes that people die by suicide for three reasons: (1) they perceive themselves as a burden to others; (2) they experience a profound feeling of disconnectedness from others, what Joiner (2005) calls ''thwarted belongingness'' (p. 118); and (3) they have become habituated to the fear and physical pain inherent in a suicidal act by repeatedly enduring painful and provocative situations, whether through such experiences as repeated suicide attempts, other physically painful experiences, or frequent exposure to danger. Importantly, all three factors must be present for a suicide to occur, according to the interpersonal-psychological theory; together, these three characteristics are ''proximal, causal, interactive risk factors'' (Van Orden, Witte, Gordon et al., 2008a, p. 72). Components of the theory have been tested in adults (Joiner, Pettit, Walker, Voelz, Cruz, \& Rudd, 2002; Joiner \& Rudd, 2000), college students, and adolescents (Joiner, Rudd, Rouleau, \& Wagner, 2000). However, research has only begun to explore whether the theory applies to Veterans (Cornette, Deboard, Clark, Holloway, Brenner, Gutierrez, et al., 2007; Cornette, deRoon-Cassini, Joiner, \& Proescher, 2006). Brenner et al. (2008) conducted a qualitative study of OEF/OIF Veterans which found relevance of the theory to their experiences. In particular, themes emerged around combat as a context for exposure to painful stimuli, perceptions of burdensomeness, and failed belongingness. This theory shows promise for designing prevention and clinical intervention strategies for Veterans, but more data are needed on which to base such work. To facilitate testing the interpersonal-psychological theory of suicide, Joiner and colleagues have developed several instruments (Bender, Gordon, \& Joiner, 2007; Bryan, Morrow, Anestis, \& Joiner, 2010; Van Orden,Witte, Gordon et al., 2008a). The Interpersonal Needs Questionnaire (INQ) taps into the constructs of thwarted belongingness and perceived burdensomeness. The Acquired Capability for Suicide Scale (ACSS; Van Orden et al., 2008) measures fearlessness about suicide. The current study will focus on the 12-item version of the INQ (INQ-12; Van Orden, Witte, Gordon, Bender, \& Joiner, 2008a) recently validated by Freedenthal, Lamis, Osman, Kahlo, and Gutierrez (2011). This measure contains seven items that assess perceived burdensomeness and five items that assess belongingness. An example of a burdensomeness item in the INQ-12 is, ''These days, I think I have failed the people in my life''. An example of a belongingness item is, ''These days, other people care about me''. The ACSS is a 20-item measure rated on a scale of 1 (not at all like me) to 5 (very much like me). Sample items include, "I am not at all afraid to die" and "I can tolerate a lot more pain than most people". Van Orden et al. report acceptable convergent and discriminant validity. The authors also reported a strong negative correlation with the fear of suicide subscale on the Reasons for Living Inventory (RFL; Linehan, Nielsen, \& Chiles, 1983) and a positive correlation with the courage to kill oneself item on the Beck Scale for Suicide Ideation (BSS; Beck \& Steer, 1991). Bender, Gordon, Bresin, and Joiner (2011) reported acceptable internal consistency as well. However, formal psychometric studies of the ACSS have yet to be conducted. Joiner (2005) describes burdensomeness, failed belongingness and acquired capability as separate constructs, with the INQ-12 and ACSS designed to assess each independently. However, for purposes of explaining whether a given individual is likely to die by suicide, Joiner et al. (2009) explain that the first two constructs together create the desire for death and that the third is necessary for a person to engage in potentially lethal self-harm behavior. Therefore, a complex interaction between the three is proposed. Support for this interaction was found by Joiner et al. in two independent samples, one community sample of young adults and a second drawing on archival data from active duty military personnel being treated for a recent significant suicide-related event (e.g., serious ideation or attempt). A major limitation of this study was that measures of the constructs differed, making it somewhat difficult to determine what was being assessed in the two samples. Additionally, in their psychometric examination of the INQ-12 Freedenthal and colleagues (2011) found evidence of an overarching factor uniting the two subscales of burdensomeness and failed belongingness. Assessing for suicide risk is a key element of the clinical management of high-risk individuals (Gutierrez et al., 2009), but is only the first step. To adequately select appropriate interventions clinicians must know what is driving an individual's suicidality (Jobes, 2006) and also what factors are keeping the person from acting on their thoughts and urges. This information better helps the clinician and client to develop strategies aimed at creating (or rediscovering) what makes life worth living; focusing on plans, goals, and hope for the future (Jobes, Comtois, Brenner, \& Gutierrez, 2011). Historically, the RFL (Linehan et al., 1983) has been one of the primary measures of protective factors against suicide, and indeed has shown great utility. A potentially related area of study is the role of one's values. The consciously chosen way in which an individual lives her life, the driving force behind her actions, and the desired outcomes of her behaviors define what an individual values (Luoma, Hayes, \& Walser, 2007). Helping clients live lives consistent with their values provides purpose and meaning, gives direction to their choices, and allows them to set reasonable, flexible goals likely to motivate meaningful action (Luoma et al.). Accomplishing these things should greatly facilitate reducing an individual's risk of suicide, since it answers the fundamental existential question "why is life worth living?" Ciarrochi and Bailey (2008) created the Survey of Life Principles to assess values, and provide preliminary support for its use in their manual.
- Conditions
- Suicide
- Keywords
- suicide, psychometric properties, military, veterans, Interpersonal needs questionnaire, Acquired capability for suicide, mental health, Survey of Life Principles, Risk assessment
- Medical subject headings
- Suicide, Psychological Well-Being
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 |
|---|---|---|
| Military Veterans | Participants will be recruited from the Denver VA Medical Center (DVAMC), regardless of clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal consistency reliability.
The internal consistency reliability statistics will be calculated for all study variables to confirm the measures are reliable.
Measured: two years
Convergent validity.
Convergent validity of the Interpersonal Needs Questionnaire (INQ) will be determined by examining the correlation between it and the other study measures.
Measured: two years
Convergent validity.
Convergent validity of the acquired capability of suicide scale (ACSS) will be determined by correlating it with all other measures.
Measured: two years
Secondary outcomes (3)
Discriminant validity.
Discriminant validity of the interpersonal needs questionnaire (INQ) will be determined by examining correlations with measures of unrelated constructs.
Measured: two years
Suicide risk.
Examine the effects of scores on the SLP on the relationship between reasons that people have for living and the potential for engaging in at-risk behavior.
Measured: two years
Discriminant validity
Examine the discriminant validity of the acquired capability for suicide scale (ACSS) by examining correlations between it and measures of unrelated constructs.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: Study should not have been listed on ClinicalTrials
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter M. Gutierrez, PhD, Principal investigator, Clinical Research Psychologist VA VISN 19 MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507675
- Sponsor's protocol ID
- COMIRB 11-0948
- Status last verified
- Mar 2014
- First submitted
- 9 Dec 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden, Belonging, and Response to Pain in Veterans
- ClinicalTrials.gov ID
- NCT01507675
- Acronym / sponsor ID
- COMIRB 11-0948
- Conditions
- Suicide
- Keywords
- suicide, psychometric properties, military, veterans, Interpersonal needs questionnaire, Acquired capability for suicide, mental health, Survey of Life Principles
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study should not have been listed on ClinicalTrials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 11 Jan 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 primary purpose of the current study is to rigorously test the psychometric properties of the INQ-12 and ACSS (Van Orden et al., 2008) in Veterans, something which has not been done to date. Factor structure, internal consistency, convergent and discriminant validity will all be assessed. Secondary goals are to determine if burdensomeness, failed belongingness, and acquired capability are distinct versus overlapping constructs and whether or not values mediate the relationship between reasons for living and suicide risk. Lastly, the inclusion of the Beck Scale for Suicidal Ideation (BSS) allows us to analyze participants' responses to explore whether or not participants can be grouped into those who want to die by suicide because they want to escape their problems and those who want to die to influence other people.
Detailed description
Suicide is a significant problem among Veterans of the U.S. Military. Katz (2007) reported that there were 144 suicides among Veterans who served in Operation Enduring Freedom (OEF) and/or Operation Iraqi Freedom (OIF) from 2002-2005. There is no nationwide surveillance system that tracks Veteran suicides. However, the National Violent Death Reporting System (NVDRS) created in 2003 by the Centers for Disease Control and Prevention (CDC) with the purpose of gathering thorough information about suicides and other violent deaths allows researchers to reasonably extrapolate national suicide rates for Veterans. A CDC report (2006) based on NVDRS data estimated that approximately 6,500 veterans from all wars die by suicide each year, accounting for approximately 20% of suicides per year nationwide. While much is known about risk factors for suicide (e.g., Beck, Steer, Kovacs, \& Garrison, 1985; Jobes \& Mann, 1999) such information has little clinical utility for predicting whether or not an individual is likely to die by suicide in the near-term. One of the few attempts to address this issue is the interpersonal-psychological theory of suicide (Joiner, 2005). The interpersonal psychological theory proposes that people die by suicide for three reasons: (1) they perceive themselves as a burden to others; (2) they experience a profound feeling of disconnectedness from others, what Joiner (2005) calls ''thwarted belongingness'' (p. 118); and (3) they have become habituated to the fear and physical pain inherent in a suicidal act by repeatedly enduring painful and provocative situations, whether through such experiences as repeated suicide attempts, other physically painful experiences, or frequent exposure to danger. Importantly, all three factors must be present for a suicide to occur, according to the interpersonal-psychological theory; together, these three characteristics are ''proximal, causal, interactive risk factors'' (Van Orden, Witte, Gordon et al., 2008a, p. 72). Components of the theory have been tested in adults (Joiner, Pettit, Walker, Voelz, Cruz, \& Rudd, 2002; Joiner \& Rudd, 2000), college students, and adolescents (Joiner, Rudd, Rouleau, \& Wagner, 2000). However, research has only begun to explore whether the theory applies to Veterans (Cornette, Deboard, Clark, Holloway, Brenner, Gutierrez, et al., 2007; Cornette, deRoon-Cassini, Joiner, \& Proescher, 2006). Brenner et al. (2008) conducted a qualitative study of OEF/OIF Veterans which found relevance of the theory to their experiences. In particular, themes emerged around combat as a context for exposure to painful stimuli, perceptions of burdensomeness, and failed belongingness. This theory shows promise for designing prevention and clinical intervention strategies for Veterans, but more data are needed on which to base such work. To facilitate testing the interpersonal-psychological theory of suicide, Joiner and colleagues have developed several instruments (Bender, Gordon, \& Joiner, 2007; Bryan, Morrow, Anestis, \& Joiner, 2010; Van Orden,Witte, Gordon et al., 2008a). The Interpersonal Needs Questionnaire (INQ) taps into the constructs of thwarted belongingness and perceived burdensomeness. The Acquired Capability for Suicide Scale (ACSS; Van Orden et al., 2008) measures fearlessness about suicide. The current study will focus on the 12-item version of the INQ (INQ-12; Van Orden, Witte, Gordon, Bender, \& Joiner, 2008a) recently validated by Freedenthal, Lamis, Osman, Kahlo, and Gutierrez (2011). This measure contains seven items that assess perceived burdensomeness and five items that assess belongingness. An example of a burdensomeness item in the INQ-12 is, ''These days, I think I have failed the people in my life''. An example of a belongingness item is, ''These days, other people care about me''. The ACSS is a 20-item measure rated on a scale of 1 (not at all like me) to 5 (very much like me). Sample items include, "I am not at all afraid to die" and "I can tolerate a lot more pain than most people". Van Orden et al. report acceptable convergent and discriminant validity. The authors also reported a strong negative correlation with the fear of suicide subscale on the Reasons for Living Inventory (RFL; Linehan, Nielsen, \& Chiles, 1983) and a positive correlation with the courage to kill oneself item on the Beck Scale for Suicide Ideation (BSS; Beck \& Steer, 1991). Bender, Gordon, Bresin, and Joiner (2011) reported acceptable internal consistency as well. However, formal psychometric studies of the ACSS have yet to be conducted. Joiner (2005) describes burdensomeness, failed belongingness and acquired capability as separate constructs, with the INQ-12 and ACSS designed to assess each independently. However, for purposes of explaining whether a given individual is likely to die by suicide, Joiner et al. (2009) explain that the first two constructs together create the desire for death and that the third is necessary for a person to engage in potentially lethal self-harm behavior. Therefore, a complex interaction between the three is proposed. Support for this interaction was found by Joiner et al. in two independent samples, one community sample of young adults and a second drawing on archival data from active duty military personnel being treated for a recent significant suicide-related event (e.g., serious ideation or attempt). A major limitation of this study was that measures of the constructs differed, making it somewhat difficult to determine what was being assessed in the two samples. Additionally, in their psychometric examination of the INQ-12 Freedenthal and colleagues (2011) found evidence of an overarching factor uniting the two subscales of burdensomeness and failed belongingness. Assessing for suicide risk is a key element of the clinical management of high-risk individuals (Gutierrez et al., 2009), but is only the first step. To adequately select appropriate interventions clinicians must know what is driving an individual's suicidality (Jobes, 2006) and also what factors are keeping the person from acting on their thoughts and urges. This information better helps the clinician and client to develop strategies aimed at creating (or rediscovering) what makes life worth living; focusing on plans, goals, and hope for the future (Jobes, Comtois, Brenner, \& Gutierrez, 2011). Historically, the RFL (Linehan et al., 1983) has been one of the primary measures of protective factors against suicide, and indeed has shown great utility. A potentially related area of study is the role of one's values. The consciously chosen way in which an individual lives her life, the driving force behind her actions, and the desired outcomes of her behaviors define what an individual values (Luoma, Hayes, \& Walser, 2007). Helping clients live lives consistent with their values provides purpose and meaning, gives direction to their choices, and allows them to set reasonable, flexible goals likely to motivate meaningful action (Luoma et al.). Accomplishing these things should greatly facilitate reducing an individual's risk of suicide, since it answers the fundamental existential question "why is life worth living?" Ciarrochi and Bailey (2008) created the Survey of Life Principles to assess values, and provide preliminary support for its use in their manual.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Military Veterans | – | –Participants will be recruited from the Denver VA Medical Center (DVAMC), regardless of clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from all individuals eligible to receive care at the Denver VA Medical Center (DVAMC), regardless of clinic.
Key inclusion criteria (3 listed)
- Military veteran
- 18 or older
- Ability to respond to questions regarding the informed consent
Key exclusion criteria (3 listed)
- Active-duty military
- Non-English speaking
- Inability to respond to questions regarding the informed consent procedure
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
Internal consistency reliability.
Time frame: two years
The internal consistency reliability statistics will be calculated for all study variables to confirm the measures are reliable.
Convergent validity.
Time frame: two years
Convergent validity of the Interpersonal Needs Questionnaire (INQ) will be determined by examining the correlation between it and the other study measures.
Convergent validity.
Time frame: two years
Convergent validity of the acquired capability of suicide scale (ACSS) will be determined by correlating it with all other measures.
3 secondary outcomes
Discriminant validity.
Time frame: two years
Suicide risk.
Time frame: two years
Discriminant validity
Time frame: two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- The mission of the VISN 19 MIRECC is to study suicide with the goal of reducing suicidality in the veteran population.Link provided by the sponsor.
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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.
Peter M. Gutierrez, PhD principal investigator
Clinical Research Psychologist 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 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 3 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: withdrawn, as of the sponsor's last update on 26 Mar 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
Internal consistency reliability. (time frame: two years). The study lists 3 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 26 Mar 2014.