Stress Disorders, PosttraumaticNCT01058031
Neural Correlates of PTSD Prevention With Mindfulness Based Stress Reduction (MBSR) in Iraqi Veterans
A study testing MBSR in people with Stress Disorders, Posttraumatic and PTSD, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive therapy control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Stress Disorders, Posttraumatic, PTSD
- What is being tested?
- MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2010
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTSD related to OEF/OIF service
Who cannot join
- History of brain injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033
About this study
Official title: Neural Correlates of PTSD Prevention With MBSR in Iraqi Veterans
The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive therapy control group.
- Conditions
- Stress Disorders, Posttraumatic, PTSD
- Being tested
- MBSR
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Mindfulness Based Stress Reduction
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | MBSR Receives: Behavioral: MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptom level measured with the CAPS
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJan 2007
- Primary completionApr 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, PosttraumaticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Doug Bremner, MD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058031
- Sponsor's protocol ID
- Bremner Merit 007
- Status last verified
- Nov 2013
- First submitted
- 26 Jan 2010
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of PTSD Prevention With MBSR in Iraqi Veterans
- ClinicalTrials.gov ID
- NCT01058031
- Acronym / sponsor ID
- Bremner Merit 007
- Conditions
- Stress Disorders, Posttraumatic, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Emory University
- Study start
- Jan 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 28 Jan 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 purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive therapy control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: MBSRMBSR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PTSD related to OEF/OIF service
Key exclusion criteria (1 listed)
- History of brain injury
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 |
|---|---|---|
| MBSRMindfulness Based Stress Reduction | Behavioural | Arm 1 |
Primary outcome
PTSD symptom level measured with the CAPS
Time frame: 3 months
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 5 Nov 2013.
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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.
Doug Bremner, MD principal investigator
Atlanta VA Medical and Rehab Center, Decatur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR in people with Stress Disorders, Posttraumatic and PTSD, run by US Department of Veterans Affairs 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 1 inclusion and 1 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 5 Nov 2013. 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?
PTSD symptom level measured with the CAPS (time frame: 3 months). 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 5 Nov 2013.