Prolonged Grief DisorderNCT01247025
Prolonged Grief and Suicide Among Veterans
An observational study of Prolonged Grief Disorder and Suicidality, run by VA Eastern Colorado Health Care System at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prolonged Grief Disorder, Suicidality
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Aug 2011
- 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: 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.
Who may be able to join
- 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)
Who cannot join
- Currently active duty in any branch of the military
- Non-English-speaking
- Inability to adequately respond to questions regarding the informed consent procedure.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eastern Colorado Health Care System (ECHCS) / Denver VA Medical Center
Denver, Colorado, 80220
VA Eastern Colorado Health Care System
Denver, Colorado, 80220
About this study
Official title: Examining Prolonged Grief Disorder and Its Relationship to Self-Directed Violence Among Veterans
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.
- Conditions
- Prolonged Grief Disorder, Suicidality
- Being tested
- No intervention
- Medical subject headings
- Prolonged Grief Disorder, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This study will not contain a specific intervention
| Study group | Role | What they receive |
|---|---|---|
| Veterans | Veterans receiving mental health services at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Grief Disorder- 13
Measured: At least six months post-bereavement
Secondary outcomes (1)
Adult Suicidal Ideation Questionnaire
Measured: Within past month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionAug 2011 (estimated)
Why it stopped: Study should not have been listed on ClinicalTrials.gov
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Grief 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver
- Investigators
- Peter M Gutierrez, PhD, Principal investigator, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247025
- Sponsor's protocol ID
- jrings1
- Status last verified
- Mar 2014
- First submitted
- 22 Nov 2010
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
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
- Examining Prolonged Grief Disorder and Its Relationship to Self-Directed Violence Among Veterans
- ClinicalTrials.gov ID
- NCT01247025
- Acronym / sponsor ID
- jrings1
- Conditions
- Prolonged Grief Disorder, Suicidality
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study should not have been listed on ClinicalTrials.gov
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- University of Colorado, Denver
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Aug 2011 (estimated)
- First posted
- 24 Nov 2010 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans | – | Other: No interventionVeterans receiving mental health services at the Eastern Colorado Healthcare System (ECHCS)/Denver Veterans Affairs Medical Center (VAMC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Currently active duty in any branch of the military
- Non-English-speaking
- Inability to adequately 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis study will not contain a specific intervention | Other | Veterans |
Primary outcome
Prolonged Grief Disorder- 13
Time frame: At least six months post-bereavement
1 secondary outcome
Adult Suicidal Ideation Questionnaire
Time frame: Within past month
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.
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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
VA Eastern Colorado Health Care System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolonged Grief Disorder and Suicidality, run by VA Eastern Colorado Health Care System at 2 sites 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 5 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 2 sites 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?
Prolonged Grief Disorder- 13 (time frame: At least six months post-bereavement). 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.