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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01334385
Other study ID # 06-1080
Secondary ID
Status Completed
Phase N/A
First received April 11, 2011
Last updated April 12, 2011
Start date March 2007
Est. completion date November 2010

Study information

Verified date April 2011
Source VA Eastern Colorado Health Care System
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date November 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

Part I:

1. OEF/OIF returned veteran

2. Age 18-55 years old

3. Active case in mental health services

Part II:

1. OEF/OIF returned veteran

2. Female

3. Age 18-55 years old

Exclusion Criteria:

1. Failure to correctly answer questions related to the informed consent process

2. Active psychosis diagnosed by primary clinician

3. Imminent suicidality

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States VA Eastern Colorado Healthcare System Denver Colorado

Sponsors (4)

Lead Sponsor Collaborator
VA Eastern Colorado Health Care System Portland State University, University of Colorado, Denver, University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

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