NCT01247025

Brief Summary

The primary research question in this study will ask, among those receiving outpatient mental health services (MHS) at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC), how many suffer from Prolonged Grief Disorder (PGD)? Here, it is hypothesized that PGD will occur within the sample. A secondary aim of this study will be to investigate how often PGD co-occurs with posttraumatic stress disorder (PTSD) and/or depression. Also, while PGD has been shown to have an effect on self-directed violence (SDV) among civilians (Prigerson, Bridge et al., 1999), no studies yet have examined the relationship between PGD and SDV among Veterans. Therefore, it also is hypothesized that as PGD severity increases among the Veteran sample, risk for SDV will increase as well. Additional research aims also will be addressed in this study. For one, it will be assessed which grief symptoms are most often reported among the Veteran sample. Also, no study has yet to examine if there are neuropsychological differences between PGD and PTSD. Therefore, another research question here is whether PGD indeed is neuropsychologically different from PTSD. Here, the exploratory hypothesis is that PGD sufferers will respond to a measure of multiple components of cognition (e.g., planning, sequencing, concentration, multitasking, and memory efficiency) in a manner that is significantly different from PTSD sufferers.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

November 22, 2010

Last Update Submit

March 21, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prolonged Grief Disorder- 13

    At least six months post-bereavement

Secondary Outcomes (1)

  • Adult Suicidal Ideation Questionnaire

    Within past month

Study Arms (1)

Veterans

Veterans receiving mental health services at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC)

Other: No intervention

Interventions

This study will not contain a specific intervention

Veterans

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants in this observational study will be all individuals willing and eligible among those seeking outpatient mental health services at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC). It is expected that 180 participants will be enrolled in an effort to obtain up to 150 completed protocols. Women and minorities will be recruited as a routine part of the study. However, given the participant population within the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC), it is expected the majority of participants will be Caucasian men.

You may qualify if:

  • Age 18 and above
  • Not currently active duty in any branch of the military
  • English-speaking
  • Ability to adequately respond to specific questions regarding the informed consent procedure.
  • Active case in Mental Health Services (MHS) at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC)

You may not qualify if:

  • Currently active duty in any branch of the military
  • Non-English-speaking
  • Inability to adequately respond to questions regarding the informed consent procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eastern Colorado Health Care System (ECHCS) / Denver VA Medical Center

Denver, Colorado, 80220, United States

Location

VA Eastern Colorado Health Care System

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Prolonged Grief DisorderSuicidal Ideation

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Peter M Gutierrez, PhD

    VA Eastern Colorado Health Care System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 24, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2011

Study Completion

August 1, 2011

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations