PTSDNCT01652430
Experiential Avoidance in Combat Veterans With and Without Posttraumatic Stress Disorder
An observational study of PTSD and Suicidal Ideation, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
This study plans to examine if symptoms of PTSD affect how Veterans who have served in combat think and react to certain information, and whether or not this has an influence on suicidal thoughts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, Suicidal Ideation
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jul 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample for the current project will be recruited from the group of veterans receiving or eligible to receive outpatient mental health services at the Denver VA Medical Center who have served in combat who may or may not have a diagnosis of PTSD.
Who may be able to join
- History of combat service
- Diagnosis of PTSD confirmed by the CAPS or
- No current diagnosis of PTSD
- Age 18-65
Who cannot join
- Inability to adequately respond to questions regarding the informed consent procedure.
- History of significant neurological disease
- Diagnosis of Schizophrenia or other Psychosis
- Alcohol abuse/dependence or illicit drug use in the two weeks prior to testing
- No history of combat service
Trial locations and contacts
1 site in 1 country.
About this study
This study plans to examine if symptoms of PTSD affect how Veterans who have served in combat think and react to certain information, and whether or not this has an influence on suicidal thoughts.
- Conditions
- PTSD, Suicidal Ideation
- Keywords
- PTSD, Suicidal ideation, Cognitive processes
- Medical subject headings
- Stress Disorders, Post-Traumatic, Suicidal Ideation
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 |
|---|---|---|
| PTSD cohort | Not described | |
| No PTSD cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Scale for Suicidal ideation
Measured: One time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nazanin Bahraini, Ph.D., Principal investigator, VA Eastern Colorado Healthcare System/MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652430
- Sponsor's protocol ID
- 10-0159
- Status last verified
- Jul 2012
- First submitted
- 9 Dec 2011
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiential Avoidance in Combat Veterans With and Without Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01652430
- Acronym / sponsor ID
- 10-0159
- Conditions
- PTSD, Suicidal Ideation
- Keywords
- PTSD, Suicidal ideation, Cognitive processes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Study start
- Oct 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Jul 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.
This study plans to examine if symptoms of PTSD affect how Veterans who have served in combat think and react to certain information, and whether or not this has an influence on suicidal thoughts.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD cohort | – | – |
| No PTSD cohort | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample for the current project will be recruited from the group of veterans receiving or eligible to receive outpatient mental health services at the Denver VA Medical Center who have served in combat who may or may not have a diagnosis of PTSD.
Key inclusion criteria (4 listed)
- History of combat service
- Diagnosis of PTSD confirmed by the CAPS or
- No current diagnosis of PTSD
- Age 18-65
Key exclusion criteria (5 listed)
- Inability to adequately respond to questions regarding the informed consent procedure.
- History of significant neurological disease
- Diagnosis of Schizophrenia or other Psychosis
- Alcohol abuse/dependence or illicit drug use in the two weeks prior to testing
- No history of combat service
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
Beck Scale for Suicidal ideation
Time frame: One time
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 8 Jan 2015.
Related trials for PTSD
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
Not yet recruiting
RISE for PTSD and Substance Use Disorder in Veterans
Stress Disorders, Post-Traumatic, Substance-Related Disorders
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Recovering Sleep After Trauma
Post-traumatic Stress Disorder
Not yet recruitingPhase 2
Written Exposure Therapy Plus Adjunctive Methylphenidate Treatment for Veterans With PTSD
PTSD - Post Traumatic Stress Disorder
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.
Nazanin Bahraini, Ph.D. principal investigator
VA Eastern Colorado Healthcare System/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 PTSD and Suicidal Ideation, 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 4 inclusion and 5 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 8 Jan 2015. 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.
What does the primary outcome measure?
Beck Scale for Suicidal ideation (time frame: One time). 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 8 Jan 2015.